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1. Longer transplant-free and liver-related event-free survival in obeticholic acid-treated patients with primary biliary cholangitis compared to external controls from two large real-world cohorts

Author

Terracciani, F., De Vincentis, A., D'Amato, D., Invernizzi, P., Morgando, A., Vanni, E., Viganò, M., Alvaro, D., Venere, R., Lleo, A., Colapietro, F., Degasperi, E., Viganò, R., Giannini, E.G., Labanca, S., Feletti, V., Mussetto, A., Cozzolongo, R., Losito, F., Pompili, M., Ponziani, F.R., Niro, G.A., Cotugno, R., Pozzoni, P., Chessa, L., Cuccorese, G., Pace Palitti, V., Russello, M., Cannavò, M., Frazzetto, E., Bertino, G., Marzioni, M., Terreni, N., Zolfino, T., Saitta, C., Pellicelli, A., Coco, B., Brunetto, M., Cazzagon, N., Floreani, A., Muratori, L., Rosina, F., Stefano, M. Di, Scifo, G., Baiocchi, L., Grassi, G., Sacco, R., Izzi, A., Crocè, S.L., Fiorini, C., Marra, F., Galli, A., Simone, L., Morelli, O., Abenavoli, L., Pizzolante, F., De Matthaeis, N., Scaravaglio, M., Gimignani, G., Boano, V., Manfredi, G.F., Marignani, M., Fanella, S., Giacchetto, M., Castellaneta, A., Poggi, G., Buzzanca, V., Scivetti, P., Tortora, A., Casella, S., Bellia, V., Omazzi, B.F., Alagna, G., Ricci, C., Poisa, P., Rigamonti, C., Calvaruso, V., Corpechot, C., Carrat, F., Hirschfield, G., Gulamhusein, A., Levy, C., Tananka, A., Montano-Loza, A. J, Londono, M., Eaton, J. E, Dalekos, G. N, Gatselis, N., Abbas, N., Trivedi, P., Thorburn, D., Bonder, A., van der Meer, A., Zigmond, E., Kremer, A. E, Bruns, T., Chazouilleres, O., Hansen, B. E, Carbone, M., and Vespasiani-Gentilucci, U.

Published
2024
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2. Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid

Author

De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., and Poggi G.

Abstract

Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with “advanced cirrhosis” because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy. Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs). Results: One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42–2.12), INR (1.37, 1.00–1.87), Child-Pugh score (1.79, 1.28–2.50), MELD (1.17, 1.04–1.30) and bilirubin (1.83, 1.11–3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10–3.36), lower albumin levels (0.18, 0.06–0.51), Child-Pugh score (2.43, 1.50–4.04), history of ascites (3.5, 1.85–6.5) and bilirubin (1.30, 1.05–1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA. Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use.

Published
2022

3. Long-term results from the Italian real-world experience on obeticholic acid treatment in primary biliary cholangitis: The RECAPITULATE study

Author

Terracciani, F., primary, De Vincentis, A., additional, D'Amato, D., additional, Invernizzi, P., additional, Morgando, A., additional, Vanni, E., additional, Viganò, M., additional, Alvaro, D., additional, Venere, R., additional, Lleo, A., additional, Colapietro, F., additional, Degasperi, E., additional, Viganò, R., additional, Giannini, E.G., additional, Labanca, S., additional, Feletti, V., additional, Mussetto, A., additional, Cozzolongo, R., additional, Losito, F., additional, Pompili, M., additional, Ponziani, F.R., additional, Niro, G.A., additional, Cotugno, R., additional, Pozzoni, P., additional, Chessa, L., additional, Cuccorese, G., additional, Palitti, V. Pace, additional, Russello, M., additional, Cannavò, M., additional, Frazzetto, E., additional, Bertino, G., additional, Marzioni, M., additional, Terreni, N., additional, Zolfino, T., additional, Saitta, C., additional, Pellicelli, A., additional, Coco, B., additional, Brunetto, M., additional, Cazzagon, N., additional, Floreani, A., additional, Muratori, L., additional, Rosina, F., additional, Di Stefano, M., additional, Scifo, G., additional, Baiocchi, L., additional, Grassi, G., additional, Sacco, R., additional, Izzi, A., additional, Crocè, S. Lory, additional, Fiorini, C., additional, Marra, F., additional, Simone, L., additional, Morelli, O., additional, Abenavoli, L., additional, Pizzolante, F., additional, De Matthaeis, N., additional, Scaravaglio, M., additional, Gimignani, G., additional, Boano, V., additional, Manfredi, G.F., additional, Marignani, M., additional, Fanella, S., additional, Giacchetto, M., additional, Castellaneta, A., additional, Poggi, G., additional, Buzzanca, V., additional, Scivetti, P., additional, Tortora, A., additional, Casella, S., additional, Bellia, V., additional, Omazzi, B.F., additional, Alagna, G., additional, Ricci, C., additional, Poisa, P., additional, Rigamonti, C., additional, Calvaruso, V., additional, Carbone, M., additional, and Vespasiani-Gentilucci, U., additional

Published
2023
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4. Prediction of response to obeticholic acid in primary biliary cholangitis: Development and validation of the OCA response score (ORS)

Author

De Vincentis, A., primary, Terracciani, F., additional, D'Amato, D., additional, Invernizzi, P., additional, Morgando, A., additional, Vanni, E., additional, Viganò, M., additional, Alvaro, D., additional, Venere, R., additional, Lleo, A., additional, Colapietro, F., additional, Degasperi, E., additional, Viganò, R., additional, Giannini, E.G., additional, Labanca, S., additional, Feletti, V., additional, Mussetto, A., additional, Cozzolongo, R., additional, Losito, F., additional, Pompili, M., additional, Ponziani, F.R., additional, Niro, G.A., additional, Cotugno, R., additional, Pozzoni, P., additional, Chessa, L., additional, Cuccorese, G., additional, Palitti, V. Pace, additional, Russello, M., additional, Cannavò, M., additional, Frazzetto, E., additional, Bertino, G., additional, Marzioni, M., additional, Terreni, N., additional, Zolfino, T., additional, Saitta, C., additional, Pellicelli, A., additional, Coco, B., additional, Brunetto, M., additional, Cazzagon, N., additional, Floreani, A., additional, Muratori, L., additional, Rosina, F., additional, Di Stefano, M., additional, Scifo, G., additional, Baiocchi, L., additional, Grassi, G., additional, Sacco, R., additional, Izzi, A., additional, Crocè, Saveria Lory, additional, Fiorini, Cecilia, additional, Marra, Fabio, additional, Simone, Loredana, additional, Morelli, Olivia, additional, Abenavoli, L., additional, Pizzolante, F., additional, De Matthaeis, N., additional, Scaravaglio, M., additional, Gimignani, G., additional, Boano, V., additional, Manfredi, G.F., additional, Marignani, M., additional, Fanella, S., additional, Giacchetto, M., additional, Castellaneta, A., additional, Poggi, G., additional, Buzzanca, V., additional, Scivetti, P., additional, Tortora, A., additional, Casella, S., additional, Bellia, V., additional, Omazzi, B.F., additional, Alagna, G., additional, Ricci, C., additional, Poisa, P., additional, Rigamonti, C., additional, Calvaruso, V., additional, Vespasiani-Gentilucci, U., additional, and Carbone, M., additional

Published
2023
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5. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author

D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., Vespasiani-Gentilucci U., D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., and Vespasiani-Gentilucci U.

Abstract

Background & aims: Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods: Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results: We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions: Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compare

Published
2021

6. Biochemical response to obeticholic acid drives liver stiffness variation over time and the risk of liver-related events in patients with primary biliary cholangitis

Author

De Vincentis, A., Terracciani, F., D'Amato, D., Scaravaglio, M., Invernizzi, P., Vanni, E., Campion, D., Floreani, A., Cazzagon, N., Alvaro, D., Venere, R., Giannini, E.G., Labanca, S., Lleo, A., Colapietro, F., Degasperi, E., Viganò, M., Pesatori, E., Fagiuoli, S., Marzioni, M., Buzzanca, V., Viganò, R., D'Amico, F., Galli, A., Curto, A., Marra, F., Begini, P., Baiocchi, L., Carnì, P., Muratori, L., Coco, B., Brunetto, M., Pizzolante, F., De Matthaeis, N., Falbo, E., Surace, L., Mattalia, A., Ieluzzi, D., Salomone, F., Delle Monache, G., Tatonetti, R., Cavalli, I., Cossiga, V., Morisco, F., Valiani, V., Gatti, P., Boccaccio, V., Angrisani, D., Vettori, G., Cuffari, B., Moretti, A., Rocco, A., Nardone, G., Scivetti, P., Costanzo, M., Boano, V., Manfredi, G.F., Simone, L., Palitti, V. Pace, Russello, M., Cannavò, M., Frazzetto, E., Bertino, G., Di Stefano, M., Izzi, A., Cerini, F., Chessa, L., Miglianti, M., Feletti, V., Mussetto, A., Cozzolongo, R., Losito, F., Niro, G.A., Cotugno, R., Sacco, R., Ricci, C., Poise, P., Cadamuro, L., Castellaneta, A., Squeo, F., Terreni, N., Bina, N., Pozzoni, P., Casella, S., Zani, F., Morelli, O., Cuccorese, G., Saitta, C., Zolfino, T., Rigamonti, C., Calvaruso, V., Carbone, M., and Vespasiani-Gentilucci, U.

Published
2024
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7. Clinical management and patient outcomes of acute lower gastrointestinal bleeding. A multicenter, prospective, cohort study

Author

Radaelli, F., Frazzoni, L., Repici, A., Rondonotti, E., Mussetto, A., Feletti, V., Spada, Cristiano, Manes, G., Segato, S., Grassi, Elisa Maria, Musso, A., Di Giulio, E., Coluccio, C., Manno, M., De Nucci, G., Festa, V., Di Leo, A., Marini, Martina, Ferraris, L., Feliziani, M., Amato, A., Soriani, P., Del Bono, C., Paggi, S., Hassan, Cesare, Fuccio, L., Spada C. (ORCID:0000-0002-5692-0960), Grassi E. (ORCID:0000-0002-8456-3702), Marini M., Hassan C., Radaelli, F., Frazzoni, L., Repici, A., Rondonotti, E., Mussetto, A., Feletti, V., Spada, Cristiano, Manes, G., Segato, S., Grassi, Elisa Maria, Musso, A., Di Giulio, E., Coluccio, C., Manno, M., De Nucci, G., Festa, V., Di Leo, A., Marini, Martina, Ferraris, L., Feliziani, M., Amato, A., Soriani, P., Del Bono, C., Paggi, S., Hassan, Cesare, Fuccio, L., Spada C. (ORCID:0000-0002-5692-0960), Grassi E. (ORCID:0000-0002-8456-3702), Marini M., and Hassan C.

Abstract

Background & aim: Although acute lower GI bleeding (LGIB) represents a significant healthcare burden, prospective real-life data on management and outcomes are scanty. Present multicentre, prospective cohort study was aimed at evaluating mortality and associated risk factors and at describing patient management. Methods: Adult outpatients acutely admitted for or developing LGIB during hospitalization were consecutively enrolled in 15 high-volume referral centers. Demographics, comorbidities, medications, interventions and outcomes were recorded. Results: Overall 1,198 patients (1060 new admissions;138 inpatients) were included. Most patients were elderly (mean-age 74±15 years), 31% had a Charlson-Comorbidity-Index ≥3, 58% were on antithrombotic therapy. In-hospital mortality (primary outcome) was 3.4% (95%CI 2.5–4.6). At logistic regression analysis, independent predictors of mortality were increasing age, comorbidity, inpatient status, hemodynamic instability at presentation, and ICU-admission. Colonoscopy had a 78.8% diagnostic yield, with significantly higher hemostasis rate when performed within 24-hours than later (21.3% vs.10.8%, p = 0.027). Endoscopic hemostasis was associated with neither in-hospital mortality nor rebleeding. A definite or presumptive source of bleeding was disclosed in 90.4% of investigated patients. Conclusion: Mortality in LGIB patients is mainly related to age and comorbidities. Although early colonoscopy has a relevant diagnostic yield and is associated with higher therapeutic intervention rate, endoscopic hemostasis is not associated with improved clinical outcomes [ClinicalTrial.gov number: NCT 04364412].

Published
2021

8. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients

Author

Fuccio, L., Frazzoni, L., Spada, Cristiano, Mussetto, A., Fabbri, Carlo, Manno, M., Aragona, G., Zagari, Rocco Maurizio, Rondonotti, E., Manes, G., Occhipinti, P., Cadoni, S., Bazzoli, F., Hassan, Cesare, Radaelli, F., Laterza, Lucrezia, Alemanni, L. V., Buttitta, F., Cirota, G., Cominardi, A., Impellizzeri, G., La Marca, M., Marasco, G., Metelli, F., Pierantoni, C., Sansone, V., Tamanini, G., Cesaro, Paola, Piccirelli, Stefania, Feletti, V., Triossi, O., Arena, Rosanna, Binda, C., Nicolini, G., Sbrancia, M., Trebbi, M., Cuffari, B., Soriani, P., Comparato, G., Prati, G. M., Reati, R., Corte, C. D., Liggi, M., Mura, D., Spada C. (ORCID:0000-0002-5692-0960), Fabbri C., Zagari R. M., Hassan C., Laterza L., Cesaro P., Piccirelli S., Arena R., Fuccio, L., Frazzoni, L., Spada, Cristiano, Mussetto, A., Fabbri, Carlo, Manno, M., Aragona, G., Zagari, Rocco Maurizio, Rondonotti, E., Manes, G., Occhipinti, P., Cadoni, S., Bazzoli, F., Hassan, Cesare, Radaelli, F., Laterza, Lucrezia, Alemanni, L. V., Buttitta, F., Cirota, G., Cominardi, A., Impellizzeri, G., La Marca, M., Marasco, G., Metelli, F., Pierantoni, C., Sansone, V., Tamanini, G., Cesaro, Paola, Piccirelli, Stefania, Feletti, V., Triossi, O., Arena, Rosanna, Binda, C., Nicolini, G., Sbrancia, M., Trebbi, M., Cuffari, B., Soriani, P., Comparato, G., Prati, G. M., Reati, R., Corte, C. D., Liggi, M., Mura, D., Spada C. (ORCID:0000-0002-5692-0960), Fabbri C., Zagari R. M., Hassan C., Laterza L., Cesaro P., Piccirelli S., and Arena R.

Abstract

Background & Aims: Hospitalization is associated with inadequate colon cleansing before colonoscopy. We aimed to identify factors associated to inadequate colon cleansing among inpatients, and to derive and validate a model to identify inpatients with inadequate cleansing. Methods: We performed a prospective observational study at 12 hospitals in Italy. Consecutive adult inpatients scheduled for colonoscopy for any indication were enrolled from February through May 2019 (derivation cohort, n = 1016) and from June through August 2019 (validation cohort, n = 508). Inadequate cleansing was defined as Boston bowel preparation scale scores below 2 in any colon segment. We performed multivariate logistic regression to identify factors associated with inadequate cleansing. Results: In the combined cohorts, 1032 patients (68%) had adequate colon cleansing. Physicians’ meetings to optimize bowel preparation (odds ratio [OR], 0.42; 95% CI, 0.27–0.65), written and oral instructions to patients (OR, 0.48; 95% CI, 0.36–0.65), admission to gastroenterology unit (OR, 0.71; 95% CI, 0.51–0.98), split-dose regimens (OR, 0.27; 95% CI, 0.20–0.35), a 1-liter polyethylene glycol-based bowel purge (OR, 0.39; 95% CI, 0.23—0.65), and 75% or more intake of bowel preparation (OR, 0.09; 95% CI, 0.05–0.15) significantly reduced odds of inadequate colon cleansing. Alternatively, bedridden status (OR, 2.14; 95% CI, 1.55–2.98), constipation (OR, 2.16; 95% CI, 1.55–3.0), diabetes mellitus (OR, 1.61; 95% CI, 1.18–2.20), use of anti-psychotic drugs (OR, 3.26; 95% CI, 1.62–6.56), and 7 or more days of hospitalization (OR, 1.02; 95% CI, 1.00–1.04) increased risk of inadequate colon cleansing. We developed a model to identify patients with inadequate cleaning using data from patients in the derivation cohort and tested it in the validation cohort. Calibration values were P = .218 for the discrimination cohort and P = .232 for the validation cohort. Discrimination values were c-statistic, 0.78 (95% C

Published
2021

10. Curative therapies are superior to standard of care (transarterial chemoembolization) for intermediate stage hepatocellular carcinoma

Author

Pecorelli A, Lenzi B, Gramenzi A, Garuti F, Farinati F, Giannini EG, Ciccarese F, Piscaglia F, Rapaccini GL, Di Marco M, Caturelli E, Zoli M, Borzio F, Sacco R, Cabibbo G, Felder M, Morisco F, Gasbarrini A, Baroni GS, Foschi FG, Biasini E, Masotto A, Virdone R, Bernardi M, Trevisani F, Bolondi L, Biselli M, Bucci L, Caraceni P, Cucchetti A, Domenicali M, Venerandi L, Giacomin A, Maddalo G, Pozzan C, Vani V, Poggio PD, Olmi S, Balsamo C, Vavassori E, Benvegnù L, Cappelli A, Golfieri R, Mosconi C, Renzulli M, Bosco G, Roselli P, Dell'Isola S, Ialungo AM, Bruzzone L, Picciotto A, Marenco S, Risso D, Sammito G, Savarino V, Cammà C, Maida M, Costantino A, Barcellona MR, Affronti A, Mega A, Rinninella E, Mismas V, Cappa FM, Dall'Aglio AC, Feletti V, Lanzi A, Neri E, Stefanini GF, Tamberi S, Missale G, Porro E, Guarino M, Gemini S, Schiadà L, for the Italian LiverCancer (ITA. LI. CA) group, Donatella Magalotti, Carla Serra, Pecorelli A, Lenzi B, Gramenzi A, Garuti F, Farinati F, Giannini EG, Ciccarese F, Piscaglia F, Rapaccini GL, Di Marco M, Caturelli E, Zoli M, Borzio F, Sacco R, Cabibbo G, Felder M, Morisco F, Gasbarrini A, Baroni GS, Foschi FG, Biasini E, Masotto A, Virdone R, Bernardi M, Trevisani F, Bolondi L, Biselli M, Bucci L, Caraceni P, Cucchetti A, Domenicali M, Magalotti D, Serra C, Venerandi L, Giacomin A, Maddalo G, Pozzan C, Vani V, Poggio PD, Olmi S, Balsamo C, Vavassori E, Benvegnù L, Cappelli A, Golfieri R, Mosconi C, Renzulli M, Bosco G, Roselli P, Dell'Isola S, Ialungo AM, Bruzzone L, Picciotto A, Marenco S, Risso D, Sammito G, Savarino V, Cammà C, Maida M, Costantino A, Barcellona MR, Affronti A, Mega A, Rinninella E, Mismas V, Cappa FM, Dall'Aglio AC, Feletti V, Lanzi A, Neri E, Stefanini GF, Tamberi S, Missale G, Porro E, Guarino M, Gemini S, Schiadà L, Pecorelli, A., Lenzi, B., Gramenzi, A., Garuti, F., Farinati, F., Giannini, E. G., Ciccarese, F., Piscaglia, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Cabibbo, G., Felder, M., Morisco, F., Gasbarrini, A., Baroni, G. S., Foschi, F. G., Biasini, E., Masotto, A., Virdone, R., Bernardi, M., Trevisani, F., Bolondi, L., Biselli, M., Bucci, L., Caraceni, P., Cucchetti, A., Domenicali, M., Magalotti, D., Serra, C., Venerandi, L., Giacomin, A., Maddalo, G., Pozzan, C., Vani, V., Poggio, P. D., Olmi, S., Balsamo, C., Vavassori, E., Benvegnu, L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Bosco, G., Roselli, P., Dell'Isola, S., Ialungo, A. M., Bruzzone, L., Picciotto, A., Marenco, S., Risso, D., Sammito, G., Savarino, V., Camma, C., Maida, M., Costantino, A., Barcellona, M. R., Affronti, A., Mega, A., Rinninella, E., Mismas, V., Cappa, F. M., Dall'Aglio, A. C., Feletti, V., Lanzi, A., Neri, E., Stefanini, G. F., Tamberi, S., Missale, G., Porro, E., Guarino, M., Gemini, S., Schiada, L., Pecorelli, Anna, Lenzi, Barbara, Gramenzi, Annagiulia, Garuti, Francesca, Farinati, Fabio, Giannini, Edoardo G, Ciccarese, Francesca, Piscaglia, Fabio, Rapaccini, Gian Lodovico, Di Marco, Maria, Caturelli, Eugenio, Zoli, Marco, Borzio, Franco, Sacco, Rodolfo, Cabibbo, Giuseppe, Felder, Martina, Morisco, Filomena, Gasbarrini, Antonio, Baroni, Gianluca Svegliati, Foschi, Francesco G, Biasini, Elisabetta, Masotto, Alberto, Virdone, Roberto, Bernardi, Mauro, and Trevisani, Franco

Subjects
Sorafenib, Male, Niacinamide, medicine.medical_specialty, Standard of care, Carcinoma, Hepatocellular, Antineoplastic Agents, Gastroenterology, Intermediate stage, 03 medical and health sciences, 0302 clinical medicine, HCC, BCLC-B, Treatment, Hepatology, Internal medicine, medicine, Humans, Chemoembolization, Therapeutic, Propensity Score, Aged, Neoplasm Staging, Retrospective Studies, intermediate stage, treatment, business.industry, Patient Selection, Phenylurea Compounds, Liver Neoplasms, Settore MED/09 - MEDICINA INTERNA, Standard of Care, Middle Aged, medicine.disease, Survival Analysis, Treatment Outcome, Italy, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Propensity score matching, Multivariate Analysis, 030211 gastroenterology & hepatology, Female, Liver function, Liver cancer, business, medicine.drug
Abstract

Background and aims the Barcelona Clinic Liver Cancer intermediate stage (BCLC-B) of hepatocellular carcinoma (HCC) includes extremely heterogeneous patients in terms of tumor burden and liver function. Transarterial-chemoembolization (TACE) is the first-line treatment for these patients although it may be risky/useless for someone, while others could undergo curative treatments. This study assesses the treatment type performed in a large cohort of BCLC-B patients and its outcome. Methods retrospective analysis of 485 consecutive BCLC-B patients from the ITA.LI.CA database diagnosed with naive HCC after 1999. Patients were stratified by treatment. Results 29 patients (6%) were lost to follow-up before receiving treatment. Treatment distribution was: TACE (233, 51.1%), curative treatments (145 patients, 31.8%), sorafenib (18, 3.9%), other (39, 8.5%), best supportive care (BSC) (21, 4.6%). Median survival (95% CI) was 45 months (37.4-52.7) for curative treatments, 30 (24.7-35.3) for TACE, 14 (10.5-17.5) for sorafenib, 14 (5.2-22.7) for other treatments and 10 (6.0-14.2) for BSC (p

Published
2017

12. Real-world data on the treatment of primary biliary cholangitis with obeticholic acid in Italy: the CLEO-AIGO OCA cohort

Author

Vespasiani-Gentilucci, U., primary, Pellicelli, A., additional, Pace-Palitti, V., additional, Rosina, F., additional, De Vincentis, A., additional, Russello, M., additional, Storato, S., additional, Cannavò, M.R., additional, Niro, G., additional, Feletti, V., additional, Mussetto, A., additional, Fontana, R., additional, Cozzolongo, R., additional, Galati, G., additional, Scifo, G., additional, Distefano, M., additional, Bertino, G., additional, Frazzetto, E., additional, Chessa, L., additional, D’Antò, M., additional, Barlattani, M., additional, Picardi, A., additional, Sacco, R., additional, Claar, E., additional, and Izzi, A., additional

Published
2020
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13. Differential diagnosis between focal nodular hyperplasia and hepatocellular adenoma: Potential role of double tracer PET with 11C-Acetate and 18F-FDG

Author

Magini G, Frigerio M, Farsad M, Serra C, Colecchia A, Jovine E, Vivarelli M, Feletti V, Golfieri R, Lodi F, Franchi R, Fanti S, Bernardi M, Trevisani F, and Magini G, Frigerio M, Farsad M, Serra C, Colecchia A, Jovine E, Vivarelli M, Feletti V, Golfieri R, Lodi F, Franchi R, Fanti S, Bernardi M, Trevisani F

Subjects
focal nodular hyperplasia, 18F-FDG, PET, hepatocellular adenoma, Positon Emission Tomography, 11C-Acetate, 18F-Fluorodeoxyglucose
Abstract

Background and Aims: We evaluated the usefulness of Positon Emission Tomography (PET) with two tracers, 11C-Acetate and 18FFluorodeoxyglucose (FDG), for differentiating focal nodular hyperplasia (FNH), that is managed conservatively, from hepatic adenoma (HA) that needs to be resected. Methods: We prospectively enrolled 30 patients with known or suspected FNH or HA. The diagnostic work-up included Doppler ultrasonography (US), contrast enhanced computed tomography (CT) and/or magnetic resonance imaging (MRI). Fine needle biopsy (FNB) was performed if imaging study was inconclusive. All patients underwent double tracer PET with a single day protocol. The images were acquired with a PET-CT tomograph to obtain image fusion. The tracer uptake was evaluated using the maximum standardized uptake value (SUVmax). The target to background (T/B) ratio was also calculated. Lesions

Published
2008

14. UDCA UP-REGULATES HUMAN PLACENTAL BCRP EXPRESSION: PRELIMINARY RESULTS

Author

Azzaroli, F., Raspanti, M. E., Alessandrelli, F., Feletti, V., Buonfiglioli, F., Cecinato, P., Montagnani, M., Colecchia, A., Festi, D., Roda, E., Mazzella, G., F. Azzaroli, M.E. Raspanti, F. Alessandrelli, V. Feletti, F. Buonfiglioli, P. Cecinato, M. Montagnani, A. Colecchia, D. Festi, E. Roda, and G. Mazzella

Subjects
BA TRANSPORTER, TROPHOBLAST, BCRP
Abstract

In Intrahepatic Cholestasis of Pregnancy (ICP) an accumulation of bile acids (BA) in the fetal compartment occurs. It is known that a BA efflux is induced by UDCA administration but the molecular basis of this transplacental transport is only partially defined. Aim of the present study was to determine if placental BCRP, able to transport BA, is regulated by UDCA in ICP. Methods: 14 pregnant women with ICP (6 untreated, 37.5±1.33 years; 8 treated with UDCA − 25 mg/kg/day, 32.14±2.16 years) and 7 agematched healthy controls (34.2±1.2 years) have agreed to participate to the study (none had gallstone disease, abnormal liver tests, liver steatosis on ultrasonography). Placentas were obtained at delivery and processed for membrane extraction. Protein expression was evaluated by standard immunoblotting techniques using actin as an internal control. Statistical differences between groups were evaluated by one way ANOVA with Dunn’s Multiple Comparison test. Results: BCRP was expressed only on the apical membrane of the syncytiotrophoblast. A significant difference was observed between the three groups (ANOVA, p = 0.01). BCRP expression was similar in cont rols and in the untreated ICP group. The administration of UDCA induced a significant increase in placental BCRP expression compared to controls (254.5±58.46 vs 100±8.002% of control, p

Published
2009

15. The foetal-maternal circulation of bile acids and bilirubin: effects of cholestasis and UDCA administration

Author

Azzaroli, F., Baglivo, E., Montagnani, M., Feletti, V., Simoni, P., Locatelli, M., DE ALOYSIO, D., Pelusi, G., Lodato, F., Festi, D., Colecchia, A., Roda, A., Roda, E., G. MAZZELLA., E. Baglivo, F. Azzaroli, M. Montagnani, V. Feletti, P. Simoni, M. Locatelli, D. De Aloysio, G. Pelusi, F. Lodato, D. Festi, A. Colecchia, A. Roda, E. Roda, G. Mazzella, and G. Mazzella.

Subjects
PREGNANCY, BILIRUBIN, CHOLESTASIS, BILE ACIDA, BILE ACIDS, UDCA
Published
2006

16. Correlazione materno-fetale degli acidi biliari in corso di colestasi gravidica

Author

Baglivo, E., Azzaroli, F., Locatelli, M., Feletti, V., Simoni, P., Santarsiero, G., Franchina, M., Rizzo, N., Lodato, Montagnani, M., Colecchia, A., Festi, D., Roda, A., Roda, E., Mazzella, G., E. Baglivo, F. Azzaroli, M. Locatelli, V. Feletti, P. Simoni, G. Santarsiero, M. Franchina, N. Rizzo, Lodato, M. Montagnani, A. Colecchia, D. Festi, A. Roda, E. Roda, and G. Mazzella

Subjects
GRAVIDANZA, ACIDO URSODEOSSICOLICO, COLESTASI, ACIDI BILIARI
Published
2005

20. Long-term treatment with α-IFN in hepatitits C recurrence after OLT

Author

Buonfiglioli, F., primary, Tamè, M.R., additional, Lodato, F., additional, Colecchia, A., additional, Cecinato, P., additional, Azzaroli, F., additional, Feletti, V., additional, Vivarelli, M., additional, Del Gaudio, M., additional, Piscaglia, F., additional, Roda, E., additional, Pinna, A.D., additional, and Mazzella, G., additional

Published
2009
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23. PA.85 HYPERTRANSAMINASEMIA AND PREGNANCY OUTCOME

Author

Azzaroli, F., primary, Di Girolamo, M., additional, Lodato, F., additional, Cecinato, P., additional, Feletti, V., additional, Alessandrelli, F., additional, Pelusi, G., additional, Colecchia, A., additional, Festi, D., additional, Roda, E., additional, and Mazzella, G., additional

Published
2008
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24. PA.190 DAILY LONG TERM ALFA-IFN IN HCV RECURRENCE AFTER LIVER TRANSPLANTATION: RESULTS OF AN ONGOING STUDY

Author

Di Girolamo, M., primary, Lodato, F., additional, Tamè, M.R., additional, Buonfiglioli, F., additional, Colecchia, A., additional, Azzaroli, F., additional, Feletti, V., additional, Cecinato, P., additional, Lisotti, A., additional, Grenci, C., additional, Roda, E., additional, Vivarelli, M., additional, Piscaglia, F., additional, Pinna, A.D., additional, and Mazzella, G., additional

Published
2008
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27. PO.27 TREATMENT OF ACUTE HEPATITIS B WITH HIGH DOSE LAMIVUDINE

Author

Lodato, F., primary, Lisotti, A., additional, Di Girolamo, M., additional, Buonfiglioli, F., additional, Festi, D., additional, Azzaroli, F., additional, Feletti, V., additional, Cecinato, P., additional, Colecchia, A., additional, Montagnani, M., additional, Granci, C., additional, Roda, E., additional, and Mazzella, G., additional

Published
2008
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28. 394 DIFFERENTIAL DIAGNOSIS BETWEEN FOCAL NODULAR HYPERPLASIA AND HEPATOCELLULAR ADENOMA: POTENTIAL ROLE OF DOUBLE TRACER PET WITH 11C-ACETATE AND 18F-FDG

Author

Magini, G., primary, Frigerio, M., additional, Farsad, M., additional, Serra, C., additional, Colecchia, A., additional, Jovine, E., additional, Vivarelli, M., additional, Feletti, V., additional, Golfieri, R., additional, Lodi, F., additional, Franchi, R., additional, Fanti, S., additional, Bernardi, M., additional, and Trevisani, F., additional

Published
2008
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29. [659] EFFECTS OF UDCA ON THE FOETUS-MATERNAL CIRCULATION OF BILIRUBIN IN CHOLESTASIS OF PREGNANCY

Author

Azzaroli, F., primary, Baglivo, E., additional, Feletti, V., additional, Locatelli, M., additional, Rizzo, N., additional, De Aloysio, D., additional, Pelusi, G., additional, Montagnani, M., additional, Lodato, F., additional, Festi, D., additional, Colecchia, A., additional, Roda, A., additional, Roda, E., additional, and Mazzella, G., additional

Published
2007
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31. 5 MRP2 is upregulated by UDCA in cholestasis of pregnancy

Author

Azzaroli, F., primary, Feletti, V., additional, Mazzeo, C., additional, Simoni, P., additional, Giovanelli, S., additional, Nigro, G., additional, Miracolo, A., additional, Lodato, F., additional, Roda, A., additional, Roda, E., additional, and Mazzela, G., additional

Published
2004
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37. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author

Anna Morgando, Mauro Viganò, Ana Lleo, Maurizio Pompili, Elisabetta De Gasperi, Daphne D’Amato, Alessandro Mussetto, Nora Cazzagon, Pietro Invernizzi, Francesca Colapietro, Vincenzo Ronca, Sara Labanca, Ester Vanni, M.R. Cannavò, Francesco Losito, Ernesto Claar, G. Scifo, Giovanni Galati, Umberto Vespasiani-Gentilucci, Silvia Storato, Alessio Gerussi, Grazia Anna Niro, Antonio Izzi, Barbara Omazzi, Antonio De Vincentis, Valentina Feletti, Giuseppe Grassi, Valeria Pace Palitti, Clara Mancuso, Vincenza Calvaruso, Evelise Frazzetto, Roberto Boldizzoni, Marco Marzioni, Floriano Rosina, Andrea Palermo, Antonino Picciotto, Valentina Bellia, Gaetano Bertino, Italian Pbc Registry, Guido Poggi, Rodolfo Sacco, Domenico Alvaro, Luigi Muratori, Maria Vinci, Marie Graciella Pigozzi, Raffaele Cozzolongo, Natalia Terreni, Annarosa Floreani, Maurizio Russello, Marco Distefano, Rinaldo Pellicano, Maria D'Antò, Marco Carbone, Rosanna Venere, R. Fontana, Antonio Picardi, Silvia Casella, S. E. O'Donnell, Federica Malinverno, Stefano Fagiuoli, Laura Cristoferi, Luchino Chessa, Giacomo Mulinacci, Pietro Pozzoni, Antonino Castellaneta, Giulia Marconi, Adriano M. Pellicelli, Francesca Romana Ponziani, Leonardo Baiocchi, D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D, De Vincentis A, Malinverno F, Viganò M, Alvaro D, Pompili M, Picciotto A, Palitti VP, Russello M, Storato S, Pigozzi MG, Calvaruso V, De Gasperi E, Lleo A, Castellaneta A, Pellicelli A, Cazzagon N, Floreani A, Muratori L, Fagiuoli S, Niro GA, Feletti V, Cozzolongo R, Terreni N, Marzioni M, Pellicano R, Pozzoni P, Baiocchi L, Chessa L, Rosina F, Bertino G, Vinci M, Morgando A, Vanni E, Scifo G, Sacco R, D'Antò M, Bellia V, Boldizzoni R, Casella S, Omazzi B, Poggi G, Cristoferi L, Gerussi A, Ronca V, Venere R, Ponziani F, Cannavò M, Mussetto A, Fontana R, Losito F, Frazzetto E, Distefano M, Colapietro F, Labanca S, Marconi G, Grassi G, Galati G, O'Donnell SE, Mancuso C, Mulinacci G, Palermo A, Claar E, Izzi A, Picardi A, Invernizzi P, Carbone M, Vespasiani-Gentilucci U, and Italian PBC Registry and the Club Epatologi Ospedalieri (CLEO)/Associazione Italiana Gastroenterologi ed Endoscopisti Digestivi Ospedalieri (AIGO) PBC Study Group.

Subjects
upper limit of normal, Cirrhosis, ALT, AMA, Autoimmunity, antinuclear antibodies, ULN, PBC, Gastroenterology, UDCA, Settore MED/12, ULN, upper limit of normal, obeticholic acid, aRR, adjusted risk ratio, CRFs, case record form, AST, aspartate transferase, Clinical endpoint, GGT, gamma-glutamyl transferase, QC, primary biliary cholangitis, Ursodeoxycholic acid, ANA, TCC, Cholestasi, TIPS, Treatment Completer Cohort, ANA, antinuclear antibodie, medicine.medical_specialty, RR, UDCA, ursodeoxycholic acid, TIPS, transjugular intrahepatic portosystemic shunt, OCA, Cirrhosi, ALP, alkaline phosphatase, autoimmune hepatitis, medicine.disease, digestive system diseases, Discontinuation, Keywords: AIH, autoimmune hepatiti, QC, quality control, chemistry, gamma-glutamyl transferase, randomised controlled trial, electronic data capture, antimitochondrial antibodies, aspartate transferase, Autoimmune hepatitis, chemistry.chemical_compound, AIH, CRFs, Immunology and Allergy, adjusted risk ratio, ANA, antinuclear antibodies, RR, risk ratio, Overall cohort, ALT, alanine transferase, AMA, antimitochondrial antibodie, Cholestasis, CRFs, case record forms, Obeticholic acid, Overlap PBC-AIH, ursodeoxycholic acid, OCA, obeticholic acid, Tolerability, alkaline phosphatase, RCT, Research Article, medicine.drug, case record forms, Context (language use), AMA, antimitochondrial antibodies, Internal medicine, EDC, electronic data capture, transjugular intrahepatic portosystemic shunt, Internal Medicine, medicine, RCT, randomised controlled trial, OC, lcsh:RC799-869, quality control, alanine transferase, AST, aRR, Hepatology, business.industry, AIH, autoimmune hepatitis, TCC, Treatment Completer Cohort, PBC, primary biliary cholangiti, GGT, risk ratio, OC, Overall cohort, ALP, lcsh:Diseases of the digestive system. Gastroenterology, PBC, primary biliary cholangitis, business, EDC
Abstract

Background & aims Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compared with patients with pure PBC. Lay summary Obeticholic acid (OCA) was shown to be effective in more than one-third of patients not responding to ursodeoxycholic acid in a real-world context in Italy. Patients with cirrhosis had more side effects with OCA, and this led to suspension of the drug in one-third of patients. OCA was also effective in patients who had overlap between autoimmune hepatitis and primary biliary cholangitis., Graphical abstract, Highlights • Under real-world conditions, OCA was effective in ~43% of patients who were non-responders to UDCA, according to Poise criteria. • Patients with cirrhosis showed lower efficacy (29.5%), mainly attributed to reduced tolerability and higher discontinuation rate. • Patients with overlap AIH-PBC showed a comparable efficacy to pure PBC, with a higher ALT reduction at 6 months. • Most patients with PBC are still in need of additional therapy if aiming to normalise liver biochemistry.

Published
2021

38. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients

Author

Giovanni Aragona, Sergio Cadoni, Gianni Nicolini, Marina La Marca, G. M. Prati, Rosario Arena, Pietro Occhipinti, Alessandro Mussetto, Franco Bazzoli, Biagio Cuffari, Giacomo Tamanini, Anna Cominardi, Cecilia Binda, Chiara Pierantoni, S. Piccirelli, Flavio Metelli, Cesare Hassan, Giovanna Impellizzeri, Liboria Laterza, Omero Triossi, Luigina Vanessa Alemanni, Rocco Maurizio Zagari, Margherita Trebbi, Cristina della Corte, Giovanna Grazia Cirota, Franco Radaelli, Carlo Fabbri, Monica Sbrancia, R. Reati, Donatella Mura, Mauro Manno, G. Comparato, Cristiano Spada, Gianpiero Manes, Giovanni Marasco, Paola Cesaro, Emanuele Rondonotti, Leonardo Frazzoni, Francesco Buttitta, Mauro Liggi, Paola Soriani, Vito Sansone, V. Feletti, Lorenzo Fuccio, Fuccio L., Frazzoni L., Spada C., Mussetto A., Fabbri C., Manno M., Aragona G., Zagari R.M., Rondonotti E., Manes G., Occhipinti P., Cadoni S., Bazzoli F., Hassan C., Radaelli F., Laterza L., Alemanni L.V., Buttitta F., Cirota G., Cominardi A., Impellizzeri G., La Marca M., Marasco G., Metelli F., Pierantoni C., Sansone V., Tamanini G., Cesaro P., Piccirelli S., Feletti V., Triossi O., Arena R., Binda C., Nicolini G., Sbrancia M., Trebbi M., Cuffari B., Soriani P., Comparato G., Prati G.M., Reati R., Corte C.D., Liggi M., and Mura D.

Subjects
Adult, medicine.medical_specialty, Constipation, Colorectal cancer, Colon, medicine.medical_treatment, Colon cleansing, Colonoscopy, Bowel Preparation, Logistic regression, Polyethylene Glycols, 03 medical and health sciences, 0302 clinical medicine, Hospitalized Patient, Predictive Model, Internal medicine, medicine, Humans, Colon Cleansing, Hepatology, medicine.diagnostic_test, business.industry, Cathartics, Gastroenterology, Odds ratio, medicine.disease, Confidence interval, 030220 oncology & carcinogenesis, Cohort, Colorectal Cancer, 030211 gastroenterology & hepatology, medicine.symptom, Inpatient, business
Abstract

Background & Aims Hospitalization is associated with inadequate colon cleansing before colonoscopy. We aimed to identify factors associated to inadequate colon cleansing among inpatients, and to derive and validate a model to identify inpatients with inadequate cleansing. Methods We performed a prospective observational study at 12 hospitals in Italy. Consecutive adult inpatients scheduled for colonoscopy for any indication were enrolled from February through May 2019 (derivation cohort, n = 1016) and from June through August 2019 (validation cohort, n = 508). Inadequate cleansing was defined as Boston bowel preparation scale scores below 2 in any colon segment. We performed multivariate logistic regression to identify factors associated with inadequate cleansing. Results In the combined cohorts, 1032 patients (68%) had adequate colon cleansing. Physicians’ meetings to optimize bowel preparation (odds ratio [OR], 0.42; 95% CI, 0.27–0.65), written and oral instructions to patients (OR, 0.48; 95% CI, 0.36–0.65), admission to gastroenterology unit (OR, 0.71; 95% CI, 0.51–0.98), split-dose regimens (OR, 0.27; 95% CI, 0.20–0.35), a 1-liter polyethylene glycol-based bowel purge (OR, 0.39; 95% CI, 0.23—0.65), and 75% or more intake of bowel preparation (OR, 0.09; 95% CI, 0.05–0.15) significantly reduced odds of inadequate colon cleansing. Alternatively, bedridden status (OR, 2.14; 95% CI, 1.55–2.98), constipation (OR, 2.16; 95% CI, 1.55–3.0), diabetes mellitus (OR, 1.61; 95% CI, 1.18–2.20), use of anti-psychotic drugs (OR, 3.26; 95% CI, 1.62–6.56), and 7 or more days of hospitalization (OR, 1.02; 95% CI, 1.00–1.04) increased risk of inadequate colon cleansing. We developed a model to identify patients with inadequate cleaning using data from patients in the derivation cohort and tested it in the validation cohort. Calibration values were P = .218 for the discrimination cohort and P = .232 for the validation cohort. Discrimination values were c-statistic, 0.78 (95% CI, 0.74–0.81) for the discrimination cohort and c-statistic, 0.73 (95% CI, 0.69–0.78) for the validation cohort. We developed app for use by clinicians. Conclusions In a prospective observational study, we identified setting-, patient- and preparation-related factors that affect colon cleansing among inpatients. We derived and validated a model to identify patients with inadequate preparation and developed an app for clinicians. ClinicalTrials.gov no: NCT03925506

Published
2019

39. Rate of non-response to ursodeoxycholic acid in a large real-world cohort of primary biliary cholangitis patients in Italy

Author

D. Bacca, Valeria Pace-Palitti, G. Scifo, Floriano Rosina, Rodolfo Sacco, Antonio Ascione, Giuseppe D'Adamo, Adriano M. Pellicelli, Luigi Elio Adinolfi, T. Zolfino, Giovanni Garrucciu, Grazia Anna Niro, Maurizio Russello, A. Barlattani, Alessandro Mussetto, Valentina Feletti, Raffaele Cozzolongo, Umberto Vespasiani-Gentilucci, Michela Barlattani, Luchino Chessa, Ernesto Claar, Antonio Izzi, Antonio De Vincentis, Gaetano Bertino, Vespasiani-Gentilucci, U, Rosina, F, Pace-Palitti, V, Sacco, R, Pellicelli, A, Chessa, L, De Vincentis, A, Barlattani, M, Barlattani, A, Feletti, V, Mussetto, A, Zolfino, T, Russello, M, Cozzolongo, R, Garrucciu, G, Niro, G, Bacca, D, Bertino, G, Claar, E, Ascione, A, D'Adamo, G, Adinolfi, Le, Scifo, G, and Izzi, A

Subjects
Adult, Male, Cholagogues and Choleretics, medicine.medical_specialty, real-world, Severity of Illness Index, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, non-responder, Primary biliary cholangitis, ursodeoxycholic acid, Internal medicine, medicine, Humans, Treatment Failure, Practice Patterns, Physicians', Response criteria, Aged, Aged, 80 and over, Liver Cirrhosis, Biliary, business.industry, Middle Aged, digestive system diseases, Ursodeoxycholic acid, Italy, Primary biliary cholangiti, 030220 oncology & carcinogenesis, Cohort, Female, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Background and aim: Response to ursodeoxycholic acid (UDCA) is crucial for the prediction of primary biliary cholangitis (PBC) prognosis, and different response criteria were validated and proposed by reference centers for PBC. To date, rates of non-response to UDCA from real-world series are lacking.Methods: Hepatology/Gastroenterology centers belonging to 'Club Epatologi Ospedalieri' (CLEO) and 'Associazione Italiana Gastroenterologi Ospedalieri' (AIGO) were invited to participate in the study, and asked to extract all patients followed for PBC, without any selection or exclusion, and fill in the database provided.Results: Thirty-four centers were enrolled throughout Italy, for a total of 713 patients. None of these centers, except one, had a hepatology outpatient clinic devoted to the care of patients with autoimmune liver diseases. After excluding 79 cases of PBC/autoimmune hepatitis overlaps, 634 patients were analyzed: mean age, 64.4 ± 12.0 years; 91.2% females; F/M 10.3/1. For patients with at least 1 year of UDCA treatment (583), rates of non-response to UDCA were evaluated according to the Paris-I/-II, Toronto and GLOBE criteria, and compared with those in the original cohorts: 27% vs 39% in Paris-I cohort; 39.6% vs 52% in Paris-II; 20.1% vs 43.5% in Toronto; 15.7% vs 30% in GLOBE (age-specific cutoffs). Mean alkaline phosphatase levels on UDCA treatment, and the age-adjusted prevalence of F3/F4 fibrosis, appeared lower in this PBC population than in reference cohorts.Conclusions: A mean ∼15% better response to UDCA is observed in a real-world PBC population, probably due to migration of some of most severe/advanced cases to PBC referral centers.

Published
2019

40. A meta-analysis of single HCV-untreated arm of studies evaluating outcomes after curative treatments of HCV-related hepatocellular carcinoma

Author

Cabibbo, Giuseppe, Petta, Salvatore, Barbã ra, Marco, Missale, Gabriele, Virdone, Roberto, Caturelli, Eugenio, Piscaglia, Fabio, Morisco, Filomena, Colecchia, Antonio, Farinati, Fabio, Giannini, Edoardo, Trevisani, Franco, Craxã¬, Antonio, Colombo, Massimo, Cammã , Calogero, Bucci, Laura, Zoli, Marco, Garuti, Francesca, Lenzi, Barbara, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Benvegnã¹, Luisa, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Ciccarese, Francesca, Del Poggio, Paolo, Olmi, Stefano, de Matthaeis, Nicoletta, Balsamo, Mariella Di Marco Claudia, Vavassori, Elena, Roselli, Paola, Dell’Isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Attardo, Simona, Rossi, Margherita, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Felder, Martina, Mega, Andrea, Gasbarrini, Antonio, Pompili, Maurizio, Rinninella, Emanuele, Sacco, Rodolfo, Mismas, Valeria, Foschi, Francesco Giuseppe, Dall’Aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Olivani, Andrea, Biasini, Elisabetta, Nardone, Gerardo, Guarino, Maria, Svegliati-Baroni, Gialuca, Ortolani, Alessio, Masotto, Alberto, Marchetti, Fabiana, Valerio, Matteo, Marra, Fabio, Aburas, Sami, Inghilesi, Andrea L, Cappelli, Alberta, Golfieri, Rita, Mosconi, MARIA CRISTINA, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Benvegnu', Luisa, Cabibbo, Giuseppe, Petta, Salvatore, Barbàra, Marco, Missale, Gabriele, Virdone, Roberto, Caturelli, Eugenio, Piscaglia, Fabio, Morisco, Filomena, Colecchia, Antonio, Farinati, Fabio, Giannini, Edoardo, Trevisani, Franco, Craxì, Antonio, Colombo, Massimo, Cammà, Calogero, Nardone, GERARDO ANTONIO PIO, Cabibbo, G., Petta, S., Barbara, M., Missale, G., Virdone, R., Caturelli, E., Piscaglia, F., Morisco, F., Colecchia, A., Farinati, F., Giannini, E., Trevisani, F., Craxi, A., Colombo, M., Camma, C., Bucci, L., Zoli, M., Garuti, F., Lenzi, B., Biselli, M., Caraceni, P., Cucchetti, A., Gramenzi, A., Granito, A., Magalotti, D., Serra, C., Negrini, G., Napoli, L., Salvatore, V., Benevento, F., Benvegnu, L., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Moscatelli, A., Pellegatta, G., Picciotto, A., Savarino, V., Ciccarese, F., Del Poggio, P., Olmi, S., de Matthaeis, N., Balsamo, M. D. M. C., Vavassori, E., Roselli, P., Dell'Isola, S., Ialungo, A. M., Rastrelli, E., Attardo, S., Rossi, M., Costantino, A., Affronti, A., Affronti, M., Mascari, M., Felder, M., Mega, A., Gasbarrini, A., Pompili, M., Rinninella, E., Sacco, R., Mismas, V., Foschi, F. G., Dall'Aglio, A. C., Feletti, V., Lanzi, A., Cappa, F. M., Neri, E., Stefanini, G. F., Tamberi, S., Olivani, A., Biasini, E., Nardone, G., Guarino, M., Svegliati-Baroni, G., Ortolani, A., Masotto, A., Marchetti, F., Valerio, M., Marra, F., Aburas, S., Inghilesi, A. L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Coccoli, P., Zamparelli, M. S., Barbã ra, Marco, Craxã¬, Antonio, Cammã , Calogero, Bucci, Laura, Zoli, Marco, Garuti, Francesca, Lenzi, Barbara, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Benvegnã¹, Luisa, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Ciccarese, Francesca, Del Poggio, Paolo, Olmi, Stefano, de Matthaeis, Nicoletta, Balsamo, Mariella Di Marco Claudia, Vavassori, Elena, Roselli, Paola, Dellâ isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Attardo, Simona, Rossi, Margherita, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Felder, Martina, Mega, Andrea, Gasbarrini, Antonio, Pompili, Maurizio, Rinninella, Emanuele, Sacco, Rodolfo, Mismas, Valeria, Foschi, Francesco Giuseppe, Dallâ aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Federica Mirici, Cappa, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Olivani, Andrea, Biasini, Elisabetta, Nardone, Gerardo, Guarino, Maria, Svegliati-Baroni, Gialuca, Ortolani, Alessio, Masotto, Alberto, Marchetti, Fabiana, Valerio, Matteo, Marra, Fabio, Aburas, Sami, Inghilesi, Andrea L, Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Camma', C., Benvegnã¹, L., Balsamo, M., Dell’Isola, S., Ialungo, A., Foschi, F., Dall’Aglio, A., Cappa, F., Stefanini, G., Inghilesi, A., and Zamparelli, M.

Subjects
Oncology, medicine.medical_specialty, Carcinoma, Hepatocellular, recurrence, Hepatitis C virus, medicine.medical_treatment, medicine.disease_cause, survival, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Adjuvant therapy, hepatocellular carcinoma, prognosis, recurrences, Humans, Survival analysis, Hepatology, business.industry, Liver Neoplasms, medicine.disease, Hepatitis C, 030220 oncology & carcinogenesis, Meta-analysis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Neoplasm Recurrence, Local, business, Adjuvant, prognosi
Abstract

Background & Aims: Determining risk for recurrence or survival after curative resection or ablation in patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) is important for stratifying patients according to expected outcomes in future studies of adjuvant therapy in the era of direct-acting antivirals (DAAs). The aims of this meta-analysis were to estimate the recurrence and survival probabilities of HCV-related early HCC following complete response after potentially curative treatment and to identify predictors of recurrence and survival. Methods: Studies reporting time-dependent outcomes (HCC recurrence or death) after potentially curative treatment of HCV-related early HCC were identified in MEDLINE through May 2016. Data on patient populations and outcomes were extracted from each study by three independent observers and combined using a distribution-free summary survival curve. Primary outcomes were actuarial probabilities of recurrence and survival. Results: Eleven studies met the inclusion criteria. Pooled estimates of actuarial recurrence rates were 7.4% at 6months and 47.0% at 2years. Pooled estimates of actuarial survival rates were 79.8% at 3years and 58.6% at 5years. Heterogeneity among studies was highly significant for all outcomes. By univariate meta-regression analyses, lower serum albumin, randomized controlled trial study design and follow-up were independently associated with higher recurrence risk, whereas tumour size and alpha-foetoprotein levels were associated with higher mortality. Conclusions: This meta-analysis showed that recurrence risk and survival are extremely variable in patients with successfully treated HCV-related HCC, providing a useful benchmark for indirect comparisons of the benefits of DAAs and for a correct design of randomized controlled trials in the adjuvant setting.

Published
2017

41. Hepatocellular carcinoma recurrence in patients with curative resection or ablation: impact of HCV eradication does not depend on the use of interferon

Author

Petta, S., Cabibbo, G., Barbara, M., Attardo, S., Bucci, L., Farinati, F., Giannini, E. G., Tovoli, F., Ciccarese, F., Rapaccini, Gian Ludovico, Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Virdone, R., Marra, F., Felder, M., Morisco, F., Benvegnù, L., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Olivani, A., Masotto, A., Nardone, G., Colecchia, A., Persico, M., Boccaccio, V., Craxì, A., Bruno, S., Trevisani, F., Cammà, C, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Domenicali, Marco, Piscaglia, Fabio, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, L., Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Delpoggio, Paolo, Olmi, Stefano, De Matthaeis, Nicoletta, Balsamo, Claudia, Vavassori, Elena, Roselli, Paola, Dell’Isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Rini, Francesca, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Mega, Andrea, Pompili, Maurizio, Rinninella, Emanuele, Mismas, Valeria, Dall’Aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Biasini, Elisabetta, Missale, Gabriele, Guarino, Maria, Ortolani, Alessio, Chiaramonte, Maria, Marchetti, Fabiana, Valerio, Matteo, Aburas, Sami, Inghilesi, Andrea L., Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Petta, Salvatore, Cabibbo, Giuseppe, Barbara, Marco, Attardo, Simona, Bucci, Laura, Farinati, Fabio, Giannini, Edoardo G., Tovoli, Francesco, Ciccarese, Francesca, Rapaccini, Gian Lodovico, Dimarco, Maria, Caturelli, Eugenio, Zoli, Marco, Borzio, Franco, Sacco, Rodolfo, Virdone, Roberto, Marra, Fabio, Felder, Martina, Morisco, Filomena, Benvegnù, Luisa, Svegliati-Baroni, Gianluca, Foschi, Francesco Giuseppe, Olivani, Andrea, Masotto, Alberto, Nardone, Gerardo, Colecchia, Antonio, Persico, Marcello, Boccaccio, Vincenzo, Craxì, Antonio, Bruno, Savino, Trevisani, Franco, Cammà, Calogero, Petta, S, Cabibbo, G, Barbara, M, Attardo, S, Bucci, L, Farinati, F, Giannini, E. G, Tovoli, F, Ciccarese, F, Rapaccini, G. L, Di Marco, M, Caturelli, E, Zoli, M, Borzio, F, Sacco, R, Virdone, R, Marra, F, Felder, M, Morisco, Filomena, Benvegnù, L, Gasbarrini, A, Svegliati Baroni, G, Foschi, F. G, Olivani, A, Masotto, A, Nardone, GERARDO ANTONIO PIO, Colecchia, A, Persico, M, Boccaccio, V, Craxì, A, Bruno, S, Trevisani, F, Cammà, C., DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE, DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, Facolta' di MEDICINA e CHIRURGIA, Da definire, AREA MIN. 06 - Scienze mediche, Petta, S., Cabibbo, G., Barbara, M., Attardo, S., Bucci, L., Farinati, F., Giannini, E., Tovoli, F., Ciccarese, F., Rapaccini, G., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Virdone, R., Marra, F., Felder, M., Morisco, F., Benvegnã¹, L., Gasbarrini, A., Svegliati-Baroni, G., Foschi, F., Olivani, A., Masotto, A., Nardone, G., Colecchia, A., Persico, M., Boccaccio, V., Craxi, A., Bruno, S., Trevisani, F., Camma', C., Biselli, M., Caraceni, P., Cucchetti, A., Domenicali, M., Piscaglia, F., Gramenzi, A., Granito, A., Magalotti, D., Serra, C., Negrini, G., Napoli, L., Salvatore, V., Benevento, F., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Moscatelli, A., Pellegatta, G., Picciotto, A., Savarino, V., Delpoggio, P., Olmi, S., Dematthaeis, N., Balsamo, C., Vavassori, E., Roselli, P., Dell’Isola, S., Ialungo, A., Rastrelli, E., Rini, F., Costantino, A., Affronti, A., Affronti, M., Mascari, M., Mega, A., Pompili, M., Rinninella, E., Mismas, V., Dall’Aglio, A., Feletti, V., Lanzi, A., Cappa, F., Neri, E., Stefanini, G., Tamberi, S., Biasini, E., Missale, G., Guarino, M., Ortolani, A., Chiaramonte, M., Marchetti, F., Valerio, M., Aburas, S., Inghilesi, A., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Coccoli, P., Zamparelli, M., Giannini, E.G., Rapaccini, G.L., Benvegnù, L., Foschi, F.G., Craxì, A., Cammà, C, the Italian Liver Cancer (ITALICA) Group [, Maurizio Biselli, Paolo Caraceni, Alessandro Cucchetti, Marco Domenicali, Fabio Piscaglia, Annagiulia Gramenzi, Alessandro Granito, Donatella Magalotti, Carla Serra, Giulia Negrini, Lucia Napoli, Veronica Salvatore, Francesca Benevento, ], Giannini, E. G., Rapaccini, G. L., Benvegnu, L., Foschi, F. G., Camma, C., Dell'Isola, S., Ialungo, A. M., Dall'Aglio, A. C., Cappa, F. M., Stefanini, G. F., Inghilesi, A. L., and Zamparelli, M. S.

Subjects
Liver Cirrhosis, Male, Cirrhosis, Databases, Factual, Gastroenterology, HCV-infected cirrhotic patients, hepatocellular carcinoma, HCC, sustained viral eradication, SVR, interferon, 0302 clinical medicine, Retrospective Studie, Pharmacology (medical), Prospective Studies, Prospective cohort study, Aged, 80 and over, Liver Neoplasms, virus diseases, Hepatitis C, Middle Aged, Liver Neoplasm, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Catheter Ablation, Interferon, 030211 gastroenterology & hepatology, Female, Liver cancer, Human, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, Liver Cirrhosi, Antiviral Agents, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Carcinoma, Early Hepatocellular Carcinoma, Humans, Aged, Retrospective Studies, Antiviral Agent, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Retrospective cohort study, medicine.disease, digestive system diseases, Surgery, Prospective Studie, Interferons, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

none 48 no Background: In HCV-infected cirrhotic patients with successfully treated early hepatocellular carcinoma (HCC), the time to HCC recurrence and the effects of sustained viral eradication (SVR) by interferon (IFN)-based or IFN-free regimens on HCC recurrence remain unclear. Aim: To perform an indirect comparison of time to recurrence (TTR) in patients with successfully treated early HCC and active HCV infection with those of patients with SVR by IFN-based and by IFN-free regimens. Methods: We evaluated 443 patients with HCV-related cirrhosis and Barcelona Clinic Liver Cancer Stage A/0 HCC who had a complete radiological response after curative resection or ablation. Active HCV infection was present in 328, selected from the Italian Liver Cancer group cohort; 58 patients had SVR achieved by IFN-free regimens after HCC cure, and 57 patients had SVR achieved by IFN-based regimens after HCC cure. Individual data of patients in the last two groups were extracted from available publications. Results: TTR by Kaplan–Meier curve was significantly lower in patients with active HCV infection compared with those with SVR both by IFN-free (P = 0.02) and by IFN-based (P < 0.001) treatments. TTR was similar in patients with SVR by IFN-free or by IFN-based (P = 0.49) strategies. Conclusion: In HCV-infected, successfully treated patients with early HCC, SVR obtained by IFN-based or IFN-free regimens significantly reduce tumour recurrence without differences related to the anti-viral strategy used. Petta, S.; Cabibbo, G.; Barbara, M.; Attardo, S.; Bucci, L.; Farinati, F.; Giannini, E.G.; Tovoli, F.; Ciccarese, F.; Rapaccini, G.L.; Di Marco, M.; Caturelli, E.; Zoli, M.; Borzio, F.; Sacco, R.; Virdone, R.; Marra, F.; Felder, M.; Morisco, F.; Benvegnù, L.; Gasbarrini, A.; Svegliati-Baroni, G.; Foschi, F.G.; Olivani, A.; Masotto, A.; Nardone, G.; Colecchia, A.; Persico, M.; Boccaccio, V.; Craxì, A.; Bruno, S.; Trevisani, F.; Cammà, C; the Italian Liver Cancer (ITALICA) Group [ ; Maurizio Biselli; Paolo Caraceni; Alessandro Cucchetti; Marco Domenicali; Fabio Piscaglia; Annagiulia Gramenzi; Alessandro Granito; Donatella Magalotti; Carla Serra; Giulia Negrini; Lucia Napoli; Veronica Salvatore; Francesca Benevento;] Petta, S.; Cabibbo, G.; Barbara, M.; Attardo, S.; Bucci, L.; Farinati, F.; Giannini, E.G.; Tovoli, F.; Ciccarese, F.; Rapaccini, G.L.; Di Marco, M.; Caturelli, E.; Zoli, M.; Borzio, F.; Sacco, R.; Virdone, R.; Marra, F.; Felder, M.; Morisco, F.; Benvegnù, L.; Gasbarrini, A.; Svegliati-Baroni, G.; Foschi, F.G.; Olivani, A.; Masotto, A.; Nardone, G.; Colecchia, A.; Persico, M.; Boccaccio, V.; Craxì, A.; Bruno, S.; Trevisani, F.; Cammà, C; the Italian Liver Cancer (ITALICA) Group [ ; Maurizio Biselli; Paolo Caraceni; Alessandro Cucchetti; Marco Domenicali; Fabio Piscaglia; Annagiulia Gramenzi; Alessandro Granito; Donatella Magalotti; Carla Serra; Giulia Negrini; Lucia Napoli; Veronica Salvatore; Francesca Benevento;]

Published
2017

42. Years of life that could be saved from prevention of hepatocellular carcinoma

Author

Andrea Costantino, Marcello Maida, Fabio Farinati, Laura Schiadà, Stefano Tamberi, Alessandro Moscatelli, Elena Rastrelli, Maria Chiaramonte, Paolo Poggio, Gianluca Svegliati Baroni, Matteo Renzulli, Fabio Piscaglia, Filomena Morisco, Paola Roselli, Roberto Virdone, Anna Maria Lalungo, Matteo Ravaioli, E.G. Giannini, Anna Chiara Dall’Aglio, Antonio Daniele Pinna, Elena Vavassori, Fabiana Marchetti, Eugenio Caturelli, Marco Domenicali, Calogero Cammà, Giulia Bosco, Carla Serra, Claudia Balsamo, Donatella Magalotti, Gian Ludovico Rapaccini, Valeria Mismas, S. Gemini, Stefano Olmi, Alberto Masotto, V. Feletti, Francesca Murer, Gaia Pellegatta, Maria Rosa Barcellona, A. Gazzola, Andrea Mega, Luigi Bolondi, Paolo Caraceni, Laura Bucci, Rita Golfieri, Annagiulia Gramenzi, Francesca Ciccarese, Rodolfo Sacco, Cristina Mosconi, Franco Borzio, Emanuele Rinninella, M. Di Marco, Alberta Cappelli, Marco Zoli, V. Vanin, Luisa Benvegnù, Mauro Bernardi, Emanuela Porro, Matteo Valerio, A. Pecorelli, Antonino Picciotto, Federica Mirici Cappa, Martina Felder, Elisabetta Biasini, Antonio Gasbarrini, Maurizio Biselli, Alessandro Cucchetti, Gabriele Missale, L. Venerandi, Serena Dell'Isola, Franco Trevisani, Elga Neri, Vincenzo Savarino, Maria Guarino, C. Pozzan, Giuseppe Cabibbo, F.G. Foschi, Giuseppe Francesco Stefanini, Arianna Lanzi, Andrea Affronti, Cucchetti, A, Trevisani, F, Bucci, L, Ravaioli, M, Farinati, F, Giannini, E. G, Ciccarese, F, Piscaglia, F, Rapaccini, G. L, Di Marco, M, Caturelli, E, Zoli, M, Borzio, F, Sacco, R, Maida, M, Felder, M, Morisco, Filomena, Gasbarrini, A, Gemini, S, Foschi, F. G, Missale, G, Masotto, A, Affronti, A, Bernardi, M, Pinna, A. D., Giannini, Eg, Rapaccini, Gl, Morisco, F, Foschi, Fg, Pinna, AD, Italian Liver Cancer (ITA.LI.CA.) Group, Bolondi, L, Biselli, M, Caraceni, P, Domenicali, M, Gramenzi, A., Cucchetti, A., Trevisani, F., Bucci, L., Ravaioli, M., Farinati, F., Giannini, E. G., Ciccarese, F., Piscaglia, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Maida, M., Felder, M., Morisco, F., Gasbarrini, A., Gemini, S., Foschi, F. G., Missale, G., Masotto, A., Affronti, A., Bernardi, M., Bolondi, L., Biselli, M., Caraceni, P., Domenicali, M., Magalotti, D., Pecorelli, A., Serra, C., Venerandi, L., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Del Poggio, P., Olmi, S., Balsamo, C., Vavassori, E., Benvegnu, L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Bosco, G., Roselli, P., Dell'Isola, S., Lalungo, A. M., Rastrelli, E., Moscatelli, A., Pellegatta, G., Picciotto, A., Savarino, V., Barcellona, M. R., Camma, C., Cabibbo, G., Costantino, A., Virdone, R., Mega, A., Rinninella, E., Mismas, V., Dall'Aglio, A. C., Feletti, V., Lanzi, A., Cappa, F. M., Neri, E., Stefanini, G. F., Tamberi, S., Biasini, E., Porro, E., Guarino, M., Baroni, G. S., Schiada, L., Chiaramonte, M., Marchetti, F., and Valerio, M.

Subjects
Registrie, Male, Pediatrics, Databases, Factual, Hepatocellular carcinoma, 0302 clinical medicine, prevention, 80 and over, Secondary Prevention, Pharmacology (medical), Prospective Studies, Registries, Young adult, Prospective cohort study, Secondary prevention, Aged, 80 and over, education.field_of_study, Liver Neoplasms, Gastroenterology, Disease Management, Middle Aged, Primary Prevention, diagnosi, Italy, Liver Neoplasm, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, Human, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, Adolescent, Population, life expentancy, Milan criteria, 03 medical and health sciences, Databases, Young Adult, Life Expectancy, medicine, Humans, Aged, education, Factual, Hepatology, business.industry, Carcinoma, Settore MED/09 - MEDICINA INTERNA, Hepatocellular, medicine.disease, Surgery, Prospective Studie, Years of potential life lost, Life expectancy, business
Abstract

Summary Background Hepatocellular carcinoma (HCC) causes premature death and loss of life expectancy worldwide. Its primary and secondary prevention can result in a significant number of years of life saved. Aim To assess how many years of life are lost after HCC diagnosis. Methods Data from 5346 patients with first HCC diagnosis were used to estimate lifespan and number of years of life lost after tumour onset, using a semi-parametric extrapolation having as reference an age-, sex- and year-of-onset-matched population derived from national life tables. Results Between 1986 and 2014, HCC lead to an average of 11.5 years-of-life lost for each patient. The youngest age-quartile group (18–61 years) had the highest number of years-of-life lost, representing approximately 41% of the overall benefit obtainable from prevention. Advancements in HCC management have progressively reduced the number of years-of-life lost from 12.6 years in 1986–1999, to 10.7 in 2000–2006 and 7.4 years in 2007–2014. Currently, an HCC diagnosis when a single tumour

Published
2016

43. Autoamputation of a large pedunculated colon polyp

Author

V. Feletti, Pietro Fusaroli, Giancarlo Caletti, Fusaroli P., Feletti V., and Caletti G.

Subjects
Male, medicine.medical_specialty, Sigmoid Diseases, business.industry, Colon, Gastroenterology, Colonic Polyps, Endoscopic ultrasonography, Colonoscopy, Middle Aged, medicine.disease, digestive system, digestive system diseases, Colon polyps, ENDOSCOPIC ULTRASONOGRAPHY, surgical procedures, operative, Neoplasm Regression, Spontaneous, Internal medicine, medicine, otorhinolaryngologic diseases, Humans, Radiology, business, Autoamputation
Abstract

A 49-year old man was referred for colonoscopy due to positive fecal occult blood test. Laboratory tests and physical examination were unrevealing. A large pedunculated polyp was found in the sigmoid colon (Figures 1A-1B). Due to inadequate bowel cleansing, polypectomy was not performed at that time. Upon repeat colonoscopy, 120 days later, bowel cleansing was excellent. The exam was performed by an expert endoscopist, achieving a good vision with a good colonic distension and without blind angulations. However, despite every effort, he was unable to find the polyp. A second expert endoscopist was asked to repeat the exam in the same session. Although he had reached the cecum twice, he couldn’t detect the polyp as well. Interestingly, both endoscopists described a prolapsed normal mucosa with a scar on its edge, in the site previously described as the polyp location (Figure 3). On close inspection, no adenomatous tissue was visible. We hypothesized a case of polyp autoamputation, with the prolapsed mucosa being the remnant of the stalk of the missing polyp. Indeed, the patient reported having suffered of a passage of bright red material and clots per rectum a few weeks before, without relevant consequences. To our knowledge only 3 cases of polyp autoamputation have been reported in the colon - ; autoamputation has been described also in the stomach and in the duodenum. It has been linked mainly with pedunculated type of polyps, which are subject to higher mechanical traction and torsion of the stalk. This is the first case documented with endoscopic images both before and after the event. Autoamputation can be either asymptomatic or accompanied by abdominal pain and bleeding, eventually leading to hospitalization.4 No fatalities have been reported. Intrinsic limitations of colonoscopy usually represent the first cause of missed polyps. Nevertheless, in case of pedunculated polyps that are not found anymore in subsequent colonoscopies, autoamputation is a possibility that gastroenterologists should take into account.

Published
2012

45. Proton pump inhibitors in cirrhosis: Tradition or evidence based practice?

Author

Francesca Lodato, Paolo Cecinato, V. Feletti, Maria Di Girolamo, Giuseppe Mazzella, Francesco Azzaroli, Andrea Lisotti, Davide Festi, Enrico Roda, Lodato F, Azzaroli F, Di Girolamo M, Feletti V, Cecinato P, Lisotti A, Festi D, Roda E, and Mazzella G.

Subjects
Liver Cirrhosis, medicine.medical_specialty, Peptic Ulcer, Cirrhosis, medicine.medical_treatment, Peptic, Disease, Review, Achlorhydria, Esophageal and Gastric Varices, Gastroenterology, Gastric Acid, Internal medicine, medicine, Sclerotherapy, Humans, CIRRHOSIS, Evidence-Based Medicine, biology, Helicobacter pylori, business.industry, HELICOBACTER P, Proton Pump Inhibitors, General Medicine, medicine.disease, biology.organism_classification, Treatment Outcome, Practice Guidelines as Topic, Gastroesophageal Reflux, Gastric acid, ACID GASTRIC SECRETION, business, Varices
Abstract

Proton pump inhibitors (PPI) are very effective in inhibiting acid secretion and are extensively used in many acid related diseases. They are also often used in patients with cirrhosis sometimes in the absence of a specific acid related disease, with the aim of preventing peptic complications in patients with variceal or hypertensive gastropathic bleeding receiving multidrug treatment. Contradicting reports support their use in cirrhosis and evidence of their efficacy in this condition is poor. Moreover there are convincing papers suggesting that acid secretion is reduced in patients with liver cirrhosis. With regard to Helicobacter pylori (H pylori) infection, its prevalence in patients with cirrhosis is largely variable among different studies, and it seems that H pylori eradication does not prevent gastro-duodenal ulcer formation and bleeding. With regard to the prevention and treatment of oesophageal complications after banding or sclerotherapy of oesophageal varices, there is little evidence for a protective role of PPI. Moreover, due to liver metabolism of PPI, the dose of most available PPIs should be reduced in cirrhotics. In conclusion, the use of this class of drugs seems more habit related than evidence-based eventually leading to an increase in health costs.

Published
2008

46. Higher doses of peginterferon alpha-2b administered twice weekly improve sustained virological response in difficult-to-treat patients with chronic hepatitis C: results of a pilot randomized study

Author

Silvia Giovanelli, Giuseppe Mazzella, V. Feletti, Mariarosa Tamè, Rosangela Muratori, Francesco Azzaroli, Enrico Roda, M.L. Bacchi Reggiani, Marco Montagnani, Francesca Lodato, Antonio Colecchia, Stefano Brillanti, Lodato F., Azzaroli F., Brillanti S., Colecchia A., Tame M.R., Montagnani M., Muratori R., Giovanelli S., Feletti V., Bacchi Reggiani M.L., Roda E., and Mazzella G.

Subjects
Adult, Male, medicine.medical_specialty, VIRAL HEPATITIS, PEGINTERFERON 12KD ALFA-2A, Pilot Projects, Interferon alpha-2, Antiviral Agents, Gastroenterology, Drug Administration Schedule, Polyethylene Glycols, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Pegylated interferon, Virology, Internal medicine, medicine, Humans, Drug Interactions, Dose-Response Relationship, Drug, Hepatology, business.industry, Ribavirin, GENOTYPE 1, Interferon-alpha, virus diseases, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Viral Load, medicine.disease, HCV, RIBAVIRIN, Recombinant Proteins, Discontinuation, Treatment Outcome, Infectious Diseases, Tolerability, chemistry, Immunology, Drug Therapy, Combination, Female, business, Viral hepatitis, Viral load, medicine.drug
Abstract

SUMMARY: Beside substantial progress in treatment of chronic hepatitis C (CHC) particular patients (genotype 1/4, high viral load, previous nonresponse, cirrhosis) remain difficult to treat. The aim of our pilot randomized study was to compare efficacy and tolerability of standard doses of Peginterferon alpha-2b + ribavirin with higher doses of Peginterferon alpha-2b administered twice weekly + ribavirin. Sixty-five outpatients with CHC were subsequently enrolled. Group A (n = 22) received recommended doses of Peginterferon alpha-2b and group B (n = 43), received high doses twice weekly. Groups were comparable for baseline characteristics. All genotype 1/4 patients had high baseline viraemia. Sustained virological response (SVR) was significantly higher in group B among naïve patients (72%vs 25%, P = 0.024). A significantly higher rate of SVR was observed in group B both considering only genotype 1/4 patients, (46%vs 13%, P = 0.03) and grouping together genotype 1/4 naive and relapsers (57%vs 11%, P = 0.039). Discontinuation rate was 32% (7 of 22) in group A and 21% (9 [corrected] of 43) in group B. Our response rates are the highest reported for genotype 1/4 with high viraemia. Our pilot study supports the need of randomized studies to evaluate both viral kinetics and efficacy of high dose and twice weekly administration of Peginterferon alpha-2b in genotype 1/4 patients with high viraemia who may need personalized treatment schedules. SUMMARY: Beside substantial progress in treatment of chronic hepatitis C (CHC) particular patients (genotype 1/4, high viral load, previous nonresponse, cirrhosis) remain difficult to treat. The aim of our pilot randomized study was to compare efficacy and tolerability of standard doses of Peginterferon alpha-2b + ribavirin with higher doses of Peginterferon alpha-2b administered twice weekly + ribavirin. Sixty-five outpatients with CHC were subsequently enrolled. Group A (n = 22) received recommended doses of Peginterferon alpha-2b and group B (n = 43), received high doses twice weekly. Groups were comparable for baseline characteristics. All genotype 1/4 patients had high baseline viraemia. Sustained virological response (SVR) was significantly higher in group B among naive patients (72%vs 25%, P = 0.024). A significantly higher rate of SVR was observed in group B both considering only genotype 1/4 patients, (46%vs 13%, P = 0.03) and grouping together genotype 1/4 naive and relapsers (57%vs 11%, P = 0.039). Discontinuation rate was 32% (7 of 22) in group A and 19% (8 of 43) in group B. Our response rates are the highest reported for genotype 1/4 with high viraemia. Our pilot study supports the need of randomized studies to evaluate both viral kinetics and efficacy of high dose and twice weekly administration of Peginterferon alpha-2b in genotype 1/4 patients with high viraemia who may need personalized treatment schedules.

Published
2005

47. Placental MRP2 is upregulated by UDCA in cholestasis of pregnancy

Author

AZZAROLI, FRANCESCO, FELETTI, VALENTINA, MAZZEO, COSTANZA, SIMONI, PATRIZIA, NIGRO, GIORGIO, LODATO, FRANCESCA, RODA, ALDO, RODA, ENRICO, MAZZELLA, GIUSEPPE, Giovanelli S., Miracolo A., Boyer J.L., Azzaroli F., Feletti V., Mazzeo C., Simoni P., Giovanelli S., Miracolo A., Nigro G., Lodato F., Roda A., Roda E., Boyer JL., and Mazzella G

Published
2004

48. Outcomes of Double Balloon-Enteroscopy in Elderly vs. Adult Patients: A Retrospective 16-Year Single-Centre Study.

Author

Trebbi M, Casadei C, Dari S, Buzzi A, Brancaccio ML, Feletti V, and Mussetto A

Abstract

Background and Aim : Double-balloon enteroscopy (DBE) is a well-established procedure for direct visualisation of the entire small bowel mucosa, and, in contrast with other imaging techniques, allows to perform biopsies and therapeutic interventions. The aim of this study was to evaluate the indications, diagnostic yield, therapeutic yield, and complications of DBE in a cohort of consecutive patients according to patients' age. Methods : We conducted a retrospective study of consecutive patients who underwent DBE in our endoscopy unit between January 2006 and December 2021. Results : A total of 387 consecutive patients who underwent 460 DBE procedures were included. Mean age of the patients was 63 years. The overall diagnostic yield was 67.6%; vascular lesions were the predominant endoscopic findings (31.5%), followed by polyps or neoplastic masses (17.6%). Older patients (≥65 years) showed statistically higher rates of clinically relevant findings than adult patients (18-65 years) ( p = 0.001). Crohn's disease and polyps or neoplastic masses were more frequent in the younger group ( p = 0.009 and p = 0.066, respectively), while vascular lesions and non-specific inflammation were the most common findings in the older group ( p < 0.001 and p < 0.001, respectively). The therapeutic intervention rate was 31.7%. Rates of endoscopic treatment were significantly higher in the older group ( p < 0.001). Total complications occurred in five procedures (1.1%). Conclusion : In clinical practice, DBE is an efficient diagnostic and therapeutic tool with a high safety profile, particularly in the elderly population.

Published
2023
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49. The management of endoscopic retrograde cholangio- pancreatography-related infections risk: results of an italian survey at regional level.

Author

Cennamo V, Landi S, Aragona G, Colecchia A, Conigliaro R, Di Lorenzo D, Di Marco M, Fabbri C, Falcone P, Gaiani F, Manno M, Merighi A, Mussetto A, Peghetti A, Sassateli R, Solfrini V, Zagari RM, Arena R, Bertani H, Binda C, Boarino V, De Padova A, Feletti V, Fuccio L, Iori V, Nervi G, Prati GM, Soriani P, and De Palma R

Subjects
Humans, Surveys and Questionnaires, Drug Resistance, Multiple, Bacterial, Italy epidemiology, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Duodenoscopes microbiology
Abstract

Background and Aim: Among the Endoscopic retrograde cholangiopancreatography (ERCP) adverse events, an increasingly arising problem is the transmission of Multi Drug Resistant (MDR) Bacteria through duodenoscopes. The aim of this survey was to evaluate the current clinical practice of management of ERCP associated infections in Emilia-Romagna, Italy., Methods: An online survey was developed including 12 questions on management of ERCP associated infections risk. The survey was proposed to all 12 endoscopy centers in Emilia Romagna that perform at least &gt; 200 ERCPs per year., Results: 11 centers completed the survey (92%). Among all risk factors of ERCP infections, hospitalization in intensive care units, immunosuppressant therapies, and previous MDR infections have achieved a 80 % minimum of concurrence by our respondents. The majority of them did not have a formalized document in their hospital describing categories and risk factors helpful in the detection of patients undergoing ERCP with an high-level infective risk (9/11, 82%). Most centers (8/11, 72%) do not perform screening in patients at risk of ERCP infections. Post procedural monitoring is performed by 6 of 11 centers (55%)., Conclusion: Our survey showed that, at least at regional level, there is a lack of procedures and protocols related to the management of patients at risk of ERCP infections.

Published
2023
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50. Clinical management and patient outcomes of acute lower gastrointestinal bleeding. A multicenter, prospective, cohort study.

Author

Radaelli F, Frazzoni L, Repici A, Rondonotti E, Mussetto A, Feletti V, Spada C, Manes G, Segato S, Grassi E, Musso A, Di Giulio E, Coluccio C, Manno M, De Nucci G, Festa V, Di Leo A, Marini M, Ferraris L, Feliziani M, Amato A, Soriani P, Del Bono C, Paggi S, Hassan C, and Fuccio L

Subjects
Age Factors, Aged, Aged, 80 and over, Comorbidity, Female, Gastrointestinal Hemorrhage etiology, Hospital Mortality, Hospitalization statistics & numerical data, Humans, Male, Middle Aged, Prospective Studies, Gastrointestinal Hemorrhage mortality
Abstract

Background & Aim: Although acute lower GI bleeding (LGIB) represents a significant healthcare burden, prospective real-life data on management and outcomes are scanty. Present multicentre, prospective cohort study was aimed at evaluating mortality and associated risk factors and at describing patient management., Methods: Adult outpatients acutely admitted for or developing LGIB during hospitalization were consecutively enrolled in 15 high-volume referral centers. Demographics, comorbidities, medications, interventions and outcomes were recorded., Results: Overall 1,198 patients (1060 new admissions;138 inpatients) were included. Most patients were elderly (mean-age 74±15 years), 31% had a Charlson-Comorbidity-Index ≥3, 58% were on antithrombotic therapy. In-hospital mortality (primary outcome) was 3.4% (95%CI 2.5-4.6). At logistic regression analysis, independent predictors of mortality were increasing age, comorbidity, inpatient status, hemodynamic instability at presentation, and ICU-admission. Colonoscopy had a 78.8% diagnostic yield, with significantly higher hemostasis rate when performed within 24-hours than later (21.3% vs.10.8%, p = 0.027). Endoscopic hemostasis was associated with neither in-hospital mortality nor rebleeding. A definite or presumptive source of bleeding was disclosed in 90.4% of investigated patients., Conclusion: Mortality in LGIB patients is mainly related to age and comorbidities. Although early colonoscopy has a relevant diagnostic yield and is associated with higher therapeutic intervention rate, endoscopic hemostasis is not associated with improved clinical outcomes [ClinicalTrial.gov number: NCT04364412]., Competing Interests: Conflict of Interest None declared., (Copyright © 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Published
2021
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