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3. Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study

Author

Carnovali, M., Spada, Cristiano, Uebel, P., Bocus, P., Cannizzaro, Rino, Cavallaro, Fabio, Cesana, Bruno Mario, Cesaro, Paola, Costamagna, Guido, Dipaolo, D., Ferrari, A. P., Hinkel, C., Kashin, S., Massella, A., Melnikova, E., Orsatti, A., Ponchon, T., Prada, A., Radaelli, F., Sferrazza, Silvia, Soru, P., Testoni, P. A., Tontini, G. E., Vecchi, M., Fiori, G., Adyshirin, Z. S., Amato, Arianna, Anesi, A., Arpurt, J. P., Attardo, S., Balzarini, M., Bellon, S., Benini, M., Blanc, P., Bonato, G., Bordin, D., Bravi, I., Bulanova, N., Bunkova, E., Cadoni, S., Carparelli, S., Chashkova, E. Y., Ciprandi, Guido, Ciuffini, Cristina, Codazzi, M., Elli, L., Fedorishina, O., Hartmann, D., Jakobs, R., Janke, D., Kamalova, O., Karpova, I., Khitaryan, A., Lombardo, V., Lovera, Mauro, Maiero, S., Manes, G., Martino, G., Merkulova, E., Mura, D., Mutignani, Massimiliano, Occhipinti, P., Pescarolo, M., Petruzziello, Lucio, Pioche, M., Pisani, Anna, Poltorykhina, E., Pretti, C., Puzzono, M., Realdon, S., Reiche, P., Roberto, P., Roman, K., Rondonotti, E., Schettino, M., Segato, S., Shishin, K., Spina, L., Stefania, M., Trovato, C., Valats, J. C., Vena, N., Veselov, V., Viale, E., Vollmar, J., Zavyalov, D., Zimmermann, Thomas Alexander, Spada C. (ORCID:0000-0002-5692-0960), Cannizzaro R., Cavallaro F., Cesana B. M., Cesaro P., Costamagna G. (ORCID:0000-0002-8100-2731), Sferrazza S., Amato A., Ciprandi G., Ciuffini C., Lovera M., Mutignani M. (ORCID:0000-0002-1272-4888), Petruzziello L., Pisani A., Zimmermann T., Carnovali, M., Spada, Cristiano, Uebel, P., Bocus, P., Cannizzaro, Rino, Cavallaro, Fabio, Cesana, Bruno Mario, Cesaro, Paola, Costamagna, Guido, Dipaolo, D., Ferrari, A. P., Hinkel, C., Kashin, S., Massella, A., Melnikova, E., Orsatti, A., Ponchon, T., Prada, A., Radaelli, F., Sferrazza, Silvia, Soru, P., Testoni, P. A., Tontini, G. E., Vecchi, M., Fiori, G., Adyshirin, Z. S., Amato, Arianna, Anesi, A., Arpurt, J. P., Attardo, S., Balzarini, M., Bellon, S., Benini, M., Blanc, P., Bonato, G., Bordin, D., Bravi, I., Bulanova, N., Bunkova, E., Cadoni, S., Carparelli, S., Chashkova, E. Y., Ciprandi, Guido, Ciuffini, Cristina, Codazzi, M., Elli, L., Fedorishina, O., Hartmann, D., Jakobs, R., Janke, D., Kamalova, O., Karpova, I., Khitaryan, A., Lombardo, V., Lovera, Mauro, Maiero, S., Manes, G., Martino, G., Merkulova, E., Mura, D., Mutignani, Massimiliano, Occhipinti, P., Pescarolo, M., Petruzziello, Lucio, Pioche, M., Pisani, Anna, Poltorykhina, E., Pretti, C., Puzzono, M., Realdon, S., Reiche, P., Roberto, P., Roman, K., Rondonotti, E., Schettino, M., Segato, S., Shishin, K., Spina, L., Stefania, M., Trovato, C., Valats, J. C., Vena, N., Veselov, V., Viale, E., Vollmar, J., Zavyalov, D., Zimmermann, Thomas Alexander, Spada C. (ORCID:0000-0002-5692-0960), Cannizzaro R., Cavallaro F., Cesana B. M., Cesaro P., Costamagna G. (ORCID:0000-0002-8100-2731), Sferrazza S., Amato A., Ciprandi G., Ciuffini C., Lovera M., Mutignani M. (ORCID:0000-0002-1272-4888), Petruzziello L., Pisani A., and Zimmermann T.

Abstract

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).

Published
2023

4. Pharmacokinetics of oral mannitol for bowel preparation for colonoscopy

Author

Fiori, G., Spada, Cristiano, Soru, P., Tontini, G. E., Bravi, I., Cesana, Bruno Mario, Cesaro, Paola, Manes, G., Orsatti, A., Prada, A., Quadarella, Alessandro, Schettino, M., Spina, L., Trovato, C., Carnovali, M., Vecchi, M., Cavallaro, Fabio, Codazzi, M., De Nucci, G., De Roberto, G., Devani, M., Di Paolo, D., Elli, L., Hinkel, C., Jakobs, R., Janke, D., Lombardo, V., Lovera, Mauro, Radaelli, F., Ravizza, D., Uebel, P., Valats, J. C., Vollmar, J., Zimmermann, Thomas Alexander, Ciprandi, Guido, Spada C. (ORCID:0000-0002-5692-0960), Cesana B. M., Cesaro P., Quadarella A., Cavallaro F., Lovera M., Zimmermann T., Ciprandi G., Fiori, G., Spada, Cristiano, Soru, P., Tontini, G. E., Bravi, I., Cesana, Bruno Mario, Cesaro, Paola, Manes, G., Orsatti, A., Prada, A., Quadarella, Alessandro, Schettino, M., Spina, L., Trovato, C., Carnovali, M., Vecchi, M., Cavallaro, Fabio, Codazzi, M., De Nucci, G., De Roberto, G., Devani, M., Di Paolo, D., Elli, L., Hinkel, C., Jakobs, R., Janke, D., Lombardo, V., Lovera, Mauro, Radaelli, F., Ravizza, D., Uebel, P., Valats, J. C., Vollmar, J., Zimmermann, Thomas Alexander, Ciprandi, Guido, Spada C. (ORCID:0000-0002-5692-0960), Cesana B. M., Cesaro P., Quadarella A., Cavallaro F., Lovera M., Zimmermann T., and Ciprandi G.

Abstract

This study aimed to define the pharmacokinetics (PKs) of oral mannitol used as an osmotic laxative for bowel preparation for colonoscopy. The PKs of oral mannitol was evaluated in a substudy as part of a phase II dose-finding, international, multicenter, randomized, parallel-group, endoscopist-blinded study. Patients were randomly assigned to take 50, 100, or 150 g mannitol. Venous blood samples were drawn at baseline (T0), 1 h (T1), 2 h (T2), 4 h (T4), and 8 h (T8) after completion of mannitol self-administration. The mean mannitol plasma concentrations (mg/ml) were dose-dependent with a consistent difference among doses. The mean maximum concentration (Cmax) ± SD was 0.63 ± 0.15, 1.02 ± 0.28, and 1.36 ± 0.39 mg/ml, in the three dosage groups, respectively. The mean area under the curve from zero to infinity (AUC0−∞) was 2.667 ± 0.668, 4.992 ± 1.706, and 7.403 ± 3.472 mg/ml*h in the 50, 100, and 150 g mannitol dose groups, respectively. Bioavailability was similar in the three dose groups and was just over 20% (0.243 ± 0.073, 0.209 ± 0.081, and 0.228 ± 0.093 in the 50, 100, and 150 g mannitol dose groups, respectively). The present study showed that the bioavailability of oral mannitol is just over 20% and is similar for the three tested doses (50, 100, and 150 g). The linear increase in Cmax, AUC0−t8, and AUC0−∞ must be considered when choosing the oral mannitol dose for bowel preparation to avoid its systemic osmotic effects.

Published
2022

5. Oral mannitol for bowel preparation: a dose-finding phase II study

Author

Spada, Cristiano, Fiori, G., Uebel, P., Tontini, G. E., Cesaro, Paola, Grazioli, L. M., Soru, P., Bravi, I., Hinkel, C., Prada, A., Di Paolo, D., Zimmermann, Thomas Alexander, Manes, G., Valats, J. C., Jakobs, R., Elli, L., Carnovali, M., Ciprandi, Guido, Radaelli, F., Vecchi, M., Spada C. (ORCID:0000-0002-5692-0960), Cesaro P., Zimmermann T., Ciprandi G., Spada, Cristiano, Fiori, G., Uebel, P., Tontini, G. E., Cesaro, Paola, Grazioli, L. M., Soru, P., Bravi, I., Hinkel, C., Prada, A., Di Paolo, D., Zimmermann, Thomas Alexander, Manes, G., Valats, J. C., Jakobs, R., Elli, L., Carnovali, M., Ciprandi, Guido, Radaelli, F., Vecchi, M., Spada C. (ORCID:0000-0002-5692-0960), Cesaro P., Zimmermann T., and Ciprandi G.

Abstract

Background: Successful bowel preparation (BP) for colonoscopy depends on the instructions, diet, the laxative product, and patient adherence, which all affect colonoscopy quality. Nevertheless, there are no laxatives which combine effectiveness, safety, easy self-administration, good patient acceptance, and low cost. However, mannitol, a sugar alcohol, could be an attractive candidate for use in clinical practice if it is shown to demonstrate adequate efficacy and safety. Aims: The present phase II dose-finding study compared three doses of mannitol (50, 100, and 150 g) to identify the best dose to be used in a subsequent phase III study. Methods: The Boston Bowel Preparation Scale, caecal intubation rate, adherence, acceptability, and safety profile, including measurement of potentially dangerous colonic gas concentrations (CH4, H2, O2), were considered in all patients. A weighted algorithm was used to identify the best mannitol dose for use in the subsequent study. Results: The per-protocol population included 60 patients in the 50 g group, 54 in the 100 g group, and 49 in the 150 g group. The 100 g dose was the best as it afforded optimal colon cleansing efficacy (94.4% of patients had adequate BP), adherence, acceptability, and safety, including negligible gas concentrations. Conclusions: The present study demonstrated that the colon cleansing efficacy and safety of mannitol were dose dependent. Conversely, gas concentrations were not dose dependent and negligible in all patients. Combined evaluation of efficacy, tolerability, and safety, using a weighted algorithm, determined that mannitol 100 g was the best dose for the phase III study.

Published
2022

21. Periendoscopic management of direct oral anticoagulants: a prospective cohort study

Author

Radaelli, F, Fuccio, L, Paggi, S, Hassan, C, Repici, A, Rondonotti, E, Semeraro, R, Di Leo, M, Anderloni, A, Amato, A, Trovato, C, Bravi, I, Buda, A, de Bellis, M, D'Angelo, V, Segato, S, Tarantino, O, Musso, A, Fasoli, R, Frazzoni, L, Liverani, E, Fabbri, C, Di Giulio, E, Esposito, G, Pigò, F, Iannone, A, Dentali, F, Bowell, Group., Radaelli, Franco, Fuccio, Lorenzo, Paggi, Silvia, Hassan, Cesare, Repici, Alessandro, Rondonotti, Emanuele, Semeraro, Rossella, Di Leo, Milena, Anderloni, Andrea, Amato, Arnaldo, Trovato, Cristina, Bravi, Ivana, Buda, Andrea, de Bellis, Mario, D'Angelo, Valentina, Segato, Sergio, Tarantino, Ottaviano, Musso, Alessandro, Fasoli, Renato, Frazzoni, Leonardo, Liverani, Elisa, Fabbri, Carlo, Di Giulio, Emilio, Esposito, Gianluca, Pigò, Flavia, Iannone, Andrea, and Dentali, Francesco

Subjects
Male, therapeutic endoscopy, medicine.medical_specialty, Time Factors, DOAC, medicine.medical_treatment, bleeding, gastroenterology, Administration, Oral, complication, 030204 cardiovascular system & hematology, Transient ischaemic attacks, Lower risk, Risk Assessment, Endoscopy, Gastrointestinal, Perioperative Care, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Thromboembolism, medicine, Humans, Prospective Studies, Elective surgery, Prospective cohort study, Gastroenterology, Aged, Rivaroxaban, business.industry, Anticoagulants, Perioperative, Middle Aged, Stroke, Treatment Outcome, Italy, Withholding Treatment, Elective Surgical Procedures, Therapeutic endoscopy, 030211 gastroenterology & hepatology, Apixaban, Female, Patient Safety, business, Gastrointestinal Hemorrhage, medicine.drug, Follow-Up Studies
Abstract

Objective To assess the frequency of adverse events associated with periendoscopic management of direct oral anticoagulants (DOACs) in patients undergoing elective GI endoscopy and the efficacy and safety of the British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) recommendations (NCT 02734316). Design Consecutive patients on DOACs scheduled for elective GI endoscopy were prospectively included. The timing of DOAC interruption and resumption before and after the procedures were recorded, along with clinical and procedural data. Procedures were stratified into low-risk and high-risk for GI-related bleeding, and patients into low-risk and high-risk for thromboembolic events. Patients were followed-up for 30 days for major and clinically relevant non-major bleeding events (CRNMB), arterial and venous thromboembolism and death. Results Of 529 patients, 38% and 62% underwent high-risk and low-risk procedures, respectively. There were 45 (8.5%; 95% CI 6.3% to 11.2%) major or CRNMB events and 2 (0.4%; 95% CI 0% to 1.4%) thromboembolic events (transient ischaemic attacks). Overall, the incidence of bleeding events was 1.8% (95% CI 0.7% to 4%) and 19.3% (95% CI 14.1% to 25.4%) in low-risk and high-risk procedures, respectively. For high-risk procedures, the incidence of intraprocedural bleeding was similar in patients who interrupted anticoagulation according to BSG/ESGE guidelines or earlier (10.3%vs10.8%, p=0.99), with a trend for a lower risk as compared with those who stopped anticoagulation later (10.3%vs25%, p=0.07). The incidence of delayed bleeding appeared similar in patients who resumed anticoagulation according to BSG/ESGE guidelines or later (6.6%vs7.7%, p=0.76), but it tended to increase when DOAC was resumed earlier (14.4%vs6.6%, p=0.27). The risk of delayed major bleeding was significantly higher in patients receiving heparin bridging than in non-bridged ones (26.6%vs5.9%, p=0.017). Conclusion High-risk procedures in patients on DOACs are associated with a substantial risk of bleeding, further increased by heparin bridging. Adoption of the BSG/ESGE guidelines in periendoscopic management of DOACs seems to result in a favourable benefit/risk ratio. Trial registration number NCT 02734316; Pre-results.

Published
2018

24. Update on Talc Pleurodesis. What’s New?

Author

Vannucci J, Capozzi R, Pecoriello R, Rao F, Floridi C, Bufalari A, Bravi I, Marziani F, Tassi V, Ceccarelli S, Ragusa M, Puma F., DADDI, NICCOLO', Vannucci J, Daddi N, Capozzi R, Pecoriello R, Rao F, Floridi C, Bufalari A, Bravi I, Marziani F, Tassi V, Ceccarelli S, Ragusa M, and Puma F.

Subjects
pleurodesis, TALC
Abstract

Introduction: Talc is currently the most common agent used for pleurodesis. Despite its role acknowledged as an effective bed side strategy primarily in neoplastic pleural effusion, recently it has been introduced in the treatment of benign diseases such as spontaneous pneumothorax. Aim of this study is to investigate side effects and results of different concentrations of talc pleurod- esis (TP) in rabbits. Materials and Methods: Twenty-six New Zealand rabbits were randomly injected intrapleurally with saline (n=6) or talc slurry at usual dosage 40mg/kg (T40, n=10) and 200mg/kg (T200, n=10). Chest tube was opened at day1 post-operative and removed in day4. Clinical signs and symptoms, fluid lactate dehydrogenase and protein levels were measured daily after the injection until drainage removal, then on day7 and before sacrifice. All groups were equally divided in two endpoints: day14 and day28. At post- mortem examination, pleurodesis was graded, according to Light criteria, from 1(none) to 8(>50% symphysis), by two observers blinded to treatment groups. Results: Adverse reactions were discovered with fever and weight loss in T200 group at 14 and 28 days. Pleurodesis score in the control Saline was negative while it did not differ significantly between T200 (4.0±1.4 at 14 days, 4.2±1.6 at 28 days) and T40 (2.8±2.0 at 14 days, 3.6±1.9 at 28 days) at days 14 and 28 (p=0.25 and p=0.56 respectively). Microscopically several granulomas, moderate localized pleural thickness, few areas of neoangiogen- esis and mediastinal lymphathic tissue infiltration were present in both study groups. Conclusions: TP at usual clinical dosage is well tolerated with acceptable clinical results. By increasing the concentration we observed severe side-effects with only mild improvement of pleurodesis.

Published
2009

27. Cortical Lewy bodies and Aβ burden are associated with prevalence and timing of dementia in Lewy body diseases

Author

Ruffmann, C., primary, Calboli, F. C. F., additional, Bravi, I., additional, Gveric, D., additional, Curry, L. K., additional, de Smith, A., additional, Pavlou, S., additional, Buxton, J. L., additional, Blakemore, A. I. F., additional, Takousis, P., additional, Molloy, S., additional, Piccini, P., additional, Dexter, D. T., additional, Roncaroli, F., additional, Gentleman, S. M., additional, and Middleton, L. T., additional

Published
2015
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29. Functional testing: pharyngeal pH monitoring and high-resolution manometry

Author

Savarino, EDOARDO VINCENZO, Zentilin, P, Savarino, V, Tenca, A, Penagini, R, Clarke, Jo, Bravi, I, Zerbib, F, and Y?ksel, Es

Subjects
Chest Pain, Esophageal pH Monitoring, NERD, Manometry, swallow, GERD, HIGH-RESOLUTION MANOMETRY, TLESR, Hydrogen-Ion Concentration, Esophagus, Electric Impedance, Gastroesophageal Reflux, Humans, Pharynx
Abstract

The following paper on functional testing of the pharynx includes commentaries on the use of 24-h pH-impedance testing to identify patients with nonacid reflux and the caveats associated with automatic and visual analysis; the potential diagnostic yield of ambulatory high-resolution manomentry (HRM), particularly in identifying non-cardiac chest pain and transient lower esophageal sphincter relaxations; the differential manometric identification of conditions facilitated by using solid swallows, and the advantages of the newly developed ResTech oropharyngeal pH probe in the detection of proximal reflux events.

Published
2013

36. Cortical Lewy bodies and Aβ burden are associated with prevalence and timing of dementia in Lewy body diseases.

Author

Ruffmann, C., Calboli, F. C. F., Bravi, I., Gveric, D., Curry, L. K., Smith, A., Pavlou, S., Buxton, J. L., Blakemore, A. I. F., Takousis, P., Molloy, S., Piccini, P., Dexter, D. T., Roncaroli, F., Gentleman, S. M., and Middleton, L. T.

Subjects
LEWY body dementia, PARKINSON'S disease, DEMENTIA, NEUROLOGICAL disorders, AMYLOID beta-protein, APOLIPOPROTEIN E
Abstract

Aims Our main objective was to determine the neuropathological correlates of dementia in patients with Lewy body disease (LBD). Furthermore, we used data derived from clinical, neuropathological and genetic studies to investigate boundary issues between Dementia with Lewy bodies (DLB) and Parkinson's disease with (PDD) and without (PDND) dementia. Methods One hundred and twenty-one cases with a neuropathological diagnosis of LBD and clinical information on dementia status were included in the analysis (55 PDD, 17 DLB and 49 PDND). We carried out topographical and semi-quantitative assessment of Lewy bodies (LB), Aβ plaques and tau-positive neuropil threads (NT). The APOE genotype and MAPT haplotype status were also determined. Results The cortical LB (CLB) burden was the only independent predictor of dementia (OR: 4.12, P < 0.001). The total cortical Aβ plaque burden was an independent predictor of a shorter latency to dementia from onset of motor signs ( P = 0.001). DLB cases had a higher LB burden in the parietal and temporal cortex, compared to PDD. Carrying at least one APOE ϵ4 allele was associated with a higher cortical LB burden ( P = 0.02), particularly in the neocortical frontal, parietal and temporal regions. Conclusions High CLB burden is a key neuropathological substrate of dementia in LBD. Elevated cortical LB pathology and Aβ plaque deposition are both correlated with a faster progression to dementia. The higher CLB load in the temporal and parietal regions, which seems to be a distinguishing feature of DLB, may account for the shorter latency to dementia and could be mediated by the APOE ϵ4 allele. [ABSTRACT FROM AUTHOR]

Published
2016
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