36 results on '"Rizzo, Giacomo Emanuele Maria"'
Search Results
2. Endoscopic ultrasound-guided mediastinal mass biopsy in an undiagnosed pediatric liver transplant recipient.
- Author
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Rizzo GEM, Traina M, Ligresti D, Carrozza L, Rancatore G, Ranucci G, and Tarantino I
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- Humans, Endosonography methods, Image-Guided Biopsy methods, Mediastinal Neoplasms diagnostic imaging, Mediastinal Neoplasms pathology, Mediastinal Neoplasms surgery, Mediastinum, Endoscopic Ultrasound-Guided Fine Needle Aspiration methods, Liver Transplantation adverse effects
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
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- 2024
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3. Endoscopic or combined management of post-surgical biliary leaks: a two-center recent experience.
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Quintini D, Rizzo GEM, Tarantino I, Sarzo G, Fantin A, Miraglia R, Maruzzelli L, Ligresti D, Carrozza L, Rancatore G, Gruttadauria S, Cillo U, Ferrara F, and Traina M
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- Humans, Retrospective Studies, Female, Male, Middle Aged, Aged, Postoperative Complications etiology, Postoperative Complications therapy, Postoperative Complications surgery, Adult, Biliary Tract Surgical Procedures methods, Treatment Outcome, Stents, Length of Stay statistics & numerical data, Biliary Tract Diseases surgery, Cholangiopancreatography, Endoscopic Retrograde methods, Anastomotic Leak therapy, Anastomotic Leak surgery, Anastomotic Leak etiology
- Abstract
Background and Aims: Post-surgical biliary leaks (PSBL) are one of the most prevalent and significant adverse events emerging after liver or biliary tract surgeries. Endoscopic retrograde cholangiopancreatography (ERCP) alone or combined with another approach (Rendez Vous) as treatment of PSBL obtains optimal outcomes due to the possibility of modifying the resistances in the biliary tree., Methods: A retrospective double-center study was conducted in two tertiary centers. Consecutive patients who underwent at least one attempt of PSBL correction by ERCP or Rendez Vous procedure between January 2018 and August 2023 were included. The primary outcome was overall endoscopic clinical success. In contrast, the secondary outcomes were hospital stay exceeding five days and endoscopic clinical success with the first endoscopic procedure at the tertiary center. Both univariate and multivariate analyses were used to assess outcomes., Results: 65 patients were included. Patients with one or multiple) leaks had more possibility to achieve the endoscopic clinical success compared to those affected by the association of leaks and stricture (96% vs 67%, p value 0.005). Leaks occurring in the main biliary duct had less probability (67%) to achieve the overall endoscopic clinical success compared to those in the end-to-end anastomosis (90%), in the resection plane or biliary stump (96%) or first or secondary order biliary branches (100%, p value 0.038). A leak-bridging stent positioning had more probability of achieving the endoscopic clinical success than a not leak-bridging stent (91% vs 53%, p value 0.005)., Conclusions: ERCP and Rendez Vous procedures are safe and effective for treating PSBL, regardless of the type of preceding surgery, even if technical or clinical success was not achieved on the first attempt. A stent should be placed, if feasible, leak-bridging to enhance treatment efficacy., Competing Interests: Declarations. Disclosures: Drs. Dario Quintini, Dr. Giacomo Emanuele Maria Rizzo, Dr. Ilaria Tarantino, Dr. Giacomo Sarzo, Dr. Alberto Fantin, Dr. Roberto Miraglia, Dr. Luigi Maruzzelli, Dr. Dario Ligresti, Dr. Lucio Carrozza, Dr. Gabriele Rancatore, Dr. Salvatore Gruttadauria, Dr. Umberto Cillo, Dr. Francesco Ferrara, and Dr Mario Traina have no conflicts of interest or financial ties to disclose., (© 2024. The Author(s).) more...
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- 2024
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4. The sword in the wall: managing biliary stents embedded in the duodenal wall following ERCP for biliary strictures after liver transplantation in an adult and a pediatric patient.
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Rizzo GEM, Tarantino I, Carrozza L, Ligresti D, Rancatore G, Giacchetto M, and Traina M
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- Humans, Cholestasis etiology, Cholestasis surgery, Cholestasis therapy, Cholestasis diagnostic imaging, Constriction, Pathologic etiology, Constriction, Pathologic surgery, Duodenum, Cholangiopancreatography, Endoscopic Retrograde methods, Liver Transplantation adverse effects, Stents adverse effects
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
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- 2024
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5. Biliary drainage in patients with malignant distal biliary obstruction: results of an Italian consensus conference.
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Marzioni M, Crinò SF, Lisotti A, Fuccio L, Vanella G, Amato A, Bertani H, Binda C, Coluccio C, Forti E, Fugazza A, Ligresti D, Maida M, Marchegiani G, Mauro A, Mirante VG, Ricci C, Rizzo GEM, Scimeca D, Spadaccini M, Arvanitakis M, Anderloni A, Fabbri C, Tarantino I, and Arcidiacono PG more...
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- Humans, Pancreatic Neoplasms complications, Pancreatic Neoplasms surgery, Cholangiocarcinoma complications, Endosonography methods, Italy, Delphi Technique, Drainage methods, Cholestasis surgery, Cholestasis etiology, Cholestasis therapy, Bile Duct Neoplasms complications, Bile Duct Neoplasms surgery, Stents
- Abstract
Background: Malignant Distal Biliary Obstruction (MBDO) is a common event occurring along the natural history of both pancreatic cancer and cholangiocarcinoma. Epidemiological and biological features make MBDO one of the key elements of the clinical management of patients suffering for of pancreatic cancer or cholangiocarcinoma. The development of dedicated biliary lumen-apposing metal stents (LAMS) is changing the clinical work up of patients with MBDO. i-EUS is an Italian network of clinicians and scientists with a special interest in biliopancreatic endoscopy, EUS in particular., Methods: The scientific methodology was chosen in line with international guidance and in a fashion similar to those applied by broader scientific associations. PICO questions were elaborated and subsequently voted by a broad panel of experts within a simplified Delphi process., Results and Conclusions: The manuscripts describes the results of a consensus conference organized by i-EUS with the aim of providing an evidence based-guidance for the appropriate use of the techniques in patients with MBDO., (© 2024. The Author(s).) more...
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- 2024
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6. The 1st i-EUS consensus on the management of pancreatic fluid collections - Part 2.
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Capurso G, Coluccio C, Rizzo GEM, Crinò SF, Cucchetti A, Facciorusso A, Hassan C, Amato A, Auriemma F, Bertani H, Binda C, Cipolletta F, Forti E, Fugazza A, Lisotti A, Maida M, Sinagra E, Sbrancia M, Spadaccini M, Tacelli M, Vanella G, Anderloni A, Fabbri C, and Tarantino I more...
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- Humans, Consensus, Italy, Pancreatitis therapy, Pancreatitis, Acute Necrotizing therapy, Pancreatitis, Acute Necrotizing diagnostic imaging, Pancreatitis, Acute Necrotizing surgery, Ultrasonography, Interventional, Drainage methods, Endosonography, Pancreatic Pseudocyst therapy, Pancreatic Pseudocyst diagnostic imaging, Pancreatic Pseudocyst surgery, Stents
- Abstract
Pancreatic fluid collections (PFCs), including pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON), are common complications of pancreatitis and pancreatic surgery. Historically, the treatment of these conditions has relied on surgical and radiological approaches. The treatment of patients with PFCs has already focused toward an endoscopy-based approach, and with the development of dedicated lumen-apposing metal stents (LAMS), it has almost totally shifted towards interventional Endoscopic Ultrasound (EUS)-guided procedures. However, there is still limited consensus on several aspects of PFCs treatment within the multidisciplinary management. The interventional endoscopy and ultrasound (i-EUS) group is an Italian network of clinicians and scientists with special interest in biliopancreatic interventional endoscopy, especially interventional EUS. This manuscript focuses on the second part of the results of a consensus conference organized by i-EUS, with the aim of providing evidence-based guidance on several intra- and post-procedural aspects of PFCs drainage, such as clinical management and follow-up., Competing Interests: Conflict of Interest There is no financial support to this study. Chiara Coluccio: Lecturer per steris. Cecilia Binda: Lecturer fees for Fujifilm, Steris, Q3 Medical, Boston Scientific. Andrea Lisotti received consultancy from Boston Scientific. Giuseppe Vanella: lecture fees from Boston Scientific and travel grants from Euromedical. Carlo Fabbri: consultant per Boston scientific, Lecturer per steris e Q3 medical All the other authors have no conflict of interest to declare., (Copyright © 2024. Published by Elsevier Ltd.) more...
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- 2024
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7. EUS-guided transesophageal fine-needle biopsy sampling of lung masses: diagnostic performance and safety.
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Rizzo GEM, Traina M, Ligresti D, Carrozza L, Rancatore G, Liotta R, Bertani A, and Tarantino I
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Background and Aims: Pulmonary masses are a diagnostic challenge in the field of EUS tissue acquisition, especially through transesophageal EUS-guided fine-needle biopsy sampling (EUS-FNB). Our study evaluated the feasibility, diagnostic performance, and safety of EUS-FNB of pulmonary lesions., Methods: Fifty-three patients were enrolled in a prospective registry. All EUS procedures were performed by experienced endosonographers. Outcomes were specimen adequacy, diagnostic accuracy, diagnostic sensibility, diagnostic specificity, and safety., Results: The mean patient age was 70 ± 10.4 years, and 71.7% were men. The mean lesion size was 52.4 ± 23.3 mm, and patients mostly had a single lesion (86.8%). Most patients had an advanced stage at diagnosis (stage IV, 41.82%), and the most common lung cancer was non-small cell lung carcinoma (69.4%). The diagnostic adequacy rate was 92.86%, and diagnostic accuracy was 87.5%. Adverse events were reported in 3 procedures., Conclusions: Transesophageal EUS-FNB is a feasible and safe diagnostic method of tissue sampling for lung masses reachable by EUS., Competing Interests: Disclosure The following author disclosed financial relationships: I. Tarantino: Consultant for Olympus and Boston Scientific. All other authors disclosed no financial relationships. Research support for this study was provided by Ministero della Salute, Ricerca corrente 2024., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.) more...
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- 2024
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8. The i-EUS consensus on the management of pancreatic fluid collections - Part 1.
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Capurso G, Rizzo GEM, Coluccio C, Crinò SF, Cucchetti A, Facciorusso A, Hassan C, Amato A, Auriemma F, Bertani H, Binda C, Cipolletta F, Forti E, Fugazza A, Lisotti A, Maida M, Sinagra E, Sbrancia M, Spadaccini M, Tacelli M, Vanella G, Anderloni A, Fabbri C, and Tarantino I more...
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- Humans, Consensus, Italy, Pancreatitis therapy, Stents, Ultrasonography, Interventional methods, Ultrasonography, Interventional standards, Consensus Development Conferences as Topic, Drainage methods, Drainage standards, Endosonography methods, Endosonography standards, Pancreatic Pseudocyst therapy, Pancreatic Pseudocyst diagnostic imaging, Pancreatic Pseudocyst surgery
- Abstract
Pancreatic fluid collections (PFCs), including pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON), are common complications of pancreatitis and pancreatic surgery. Historically, the treatment of these conditions has relied on surgical and radiological approaches; however, it has later shifted toward an endoscopy-based approach. With the development of dedicated lumen-apposing metal stents (LAMS), interventional Endoscopic Ultrasound (EUS)-guided procedures have become the standard approach for PFC drainage. However, there is still limited consensus on several aspects of the multidisciplinary management of PFCs. The interventional endoscopy and ultrasound (i-EUS) group is an Italian network of clinicians and scientists with special interest in biliopancreatic interventional endoscopy, especially interventional EUS. This manuscript describes the first part of the results of a consensus conference organized by i-EUS with the aim of providing evidence-based guidance on aspects such as indications for treating PFCs, the timing of intervention, and different technical strategies for managing patients with PFCs., Competing Interests: Conflict of Interest There is no financial support to this study. Chiara Coluccio: Lecturer per steris Cecilia Binda: Lecturer fees for Fujifilm, Steris, Q3 Medical, Boston Scientific. Andrea Lisotti received consultancy from Boston Scientific Giuseppe Vanella: lecture fees from Boston Scientific and travel grants from Euromedical Carlo Fabbri: consultant per Boston scientific, Lecturer per steris e Q3 medical All the other authors have no conflict of interest to declare., (Copyright © 2024. Published by Elsevier Ltd.) more...
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- 2024
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9. Unveiling hidden outcomes in malignant gastric outlet obstruction research - insights from a "Pancreas 2000" review.
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Vilas-Boas F, Rizzo GEM, De Ponthaud C, Robinson S, Gaujoux S, Capurso G, Vanella G, and Bozkırlı B
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Malignant gastric outlet obstruction (mGOO) is a major condition affecting patients with periampullary tumors, including pancreatic cancer. The current treatment options include surgical gastroenterostomy, endoscopic stenting and more recently EUS-guided gastroenterostomy. Most studies comparing the outcomes of the three procedures focus on technical success, clinical success and safety. Several "occult" outcomes relevant to the patient's viewpoints and perspective may ultimately impact on cancer-related and overall survival, such as body mass composition, nutritional biomarkers, chemotherapy tolerance and patient-reported quality of life. The aim of this review is to provide an overview of potential key outcomes that should be explored in future comparative research around mGOO treatment options., Competing Interests: Conflict-of-interest statement: Authors declare no conflict of interests for this article., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.) more...
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- 2024
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10. Endoscopic Ultrasound-Guided Fine Needle Biopsy of Focal Liver Lesions: An Effective Mini-Invasive Alternative to the Percutaneous Approach.
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Rancatore G, Ligresti D, Rizzo GEM, Carrozza L, Traina M, and Tarantino I
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Despite the introduction of serological neoplastic biomarkers and typical radiological characteristics in clinical practice, liver biopsy (LB) is often still necessary to establish a histological diagnosis, especially in ambiguous cases. Nowadays, LB via the percutaneous approach (PC-LB), under computed tomography (CT) scan or ultrasonography (US) guidance, is the route of choice. However, certain focal liver lesions can be challenging to access percutaneously. In such cases, endoscopic ultrasound (EUS)-guided fine needle biopsy (FNB) may represent an attractive, minimally invasive alternative. This retrospective observational study aimed to evaluate the efficacy, diagnostic performance, and safety of EUS-FNB conducted on 58 focal liver lesions located in both liver lobes. The adequacy of FNB samples for focal liver lesions located in the left and right lobes was 100% and 81.2%, respectively, and the difference was statistically significant ( p = 0.001). Technical success was 100% for both liver lobes. The overall sensitivity and specificity were 95% and 100%, respectively. EUS-FNB is effective in making an accurate diagnosis with an excellent safety profile for focal liver lesions located in both liver lobes. more...
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- 2024
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11. Management of malignant Gastric Outlet Obstruction (mGOO) due to pancreatic cancer in the era of EUS-Gastrojejunostomy: an international practice survey and case vignette study by Pancreas 2000 from the European Pancreatic Club.
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De Ponthaud C, Bozkirli B, Rizzo GEM, Robinson S, Vilas-Boas F, Capurso G, Gaujoux S, and Vanella G
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- Humans, Endosonography methods, Male, Clinical Decision-Making, Female, Stents, Surveys and Questionnaires, Europe, Middle Aged, Gastric Outlet Obstruction surgery, Gastric Outlet Obstruction etiology, Pancreatic Neoplasms complications, Pancreatic Neoplasms surgery, Gastric Bypass methods, Practice Patterns, Physicians' statistics & numerical data
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Background: Malignant Gastric Outlet Obstruction (mGOO) has been standardly treated by surgical Gastrojejunostomy (S-GJ) or Endoscopic Stenting (ES). Recently, EUS-Gastrojejunostomy (EUS-GJ) has emerged as an alternative, despite its worldwide diffusion is heterogeneous. The aim of this survey was to assess clinical decision-making around mGOO and to explore current opinions regarding EUS-GJ., Methods: An online survey, spread through social networks and EPC newsletter, was created exploring opinions regarding indications, contraindications, benefits/risks, availability of mGOO treatments; 2 case vignettes explored clinical decision-making in different scenarios., Results: Overall, 290 pancreatologists from 44 countries responded, of whom 35% surgeons and 65% gastroenterologists. The most common treatment for mGOO was ES (86%), followed by laparoscopic GJ (76%). EUS-GJ was accessible to 59% of respondents, with 10% proficient in this technique. Gold-standard treatment for mGOO varied by specialty; 45% of gastroenterologists preferred ES, 20% EUS-GJ, and 10% surgical GJ, while among surgeons, these were 24%, 8%, and 25%, respectively. A higher annual volume of mGOO treated correlated with increased EUS-GJ adoption and reduced surgical advice. For 51%, EUS-GJ will become the primary treatment for mGOO, notably higher among gastroenterologists and high-volume centers. For 14%, EUS-GJ spread will be limited in the future, or used only when ES fails (19%). Life expectancy, disease stage and patient's frailty are the main decision driver in therapeutic choice, whereas future surgical resectability does not contraindicate any treatment for 75%. EUS-GJ's main advantages were its minimally invasive nature and clinical efficacy, offset by its steep learning curve., Conclusions: This survey revealed significant differences in the management of mGOO, depending on specialties, local expertise and treatment volume, suggesting the lack of standardized algorithms. Life expectancy and patients' frailty are the main decision drivers. Regarding EUS-GJ, its availability remains suboptimal, with learning curve as the main perceived barrier., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.) more...
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- 2024
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12. Navigating the Labyrinth: When the "Mesenterium Commune" Turns Colonoscopy into an Endoscopic Rollercoaster.
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Rizzo GEM, Ferriolo S, Carrozza L, Rancatore G, and Traina M
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These images involved the case of a 51-year-old woman who had a history of chronic abdominal pain, iron deficiency, and diarrhoea but no blood or mucus in her stool. She had never undergone major abdominal surgery, and her past medical evaluation diagnosed her with celiac disease, leading to the adoption of a gluten-free diet alleviating most of her gastrointestinal symptoms. However, years later, her abdominal pain returned, so she underwent an abdominal ultrasound, revealing non-specific bowel loop dilation, and a weakly positive faecal occult blood test led to a colonoscopy. Despite many efforts to advance the scope beyond the transverse colon, colonoscopy was arduous and not complete, even after several changes in decubitus and abdominal compressions. Therefore, a virtual colonoscopy was conducted, revealing no intraluminal masses, but the entire colon was located on the left side of the abdomen. Indeed, the results showed sigma and that most of the colon was curled up in the small pelvis. This rare anatomical variant, known as "Mesenterium commune" (MC), is a type of gut malrotation that develops in childhood due to a lack of omphalomesenteric loop rotation during the embryonic period. This condition can lead to episodes of intestinal obstruction, potentially resulting in an acute abdomen and leading to surgical correction. Symptoms include chronic recurring abdominal pain, nausea, vomiting, and occasionally bloody stools. Few cases of this extremely rare condition have been reported in the literature so far. more...
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- 2024
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13. Endoscopic Retrograde Cholangiopancreatography (ERCP) for Suspected Mirizzi Syndrome Type IV as Both a Diagnostic and Bridge-to-Surgery Procedure.
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Rizzo GEM, Caruso S, and Tarantino I
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Mirizzi syndrome (MS) is a challenging diagnosis due to its similar presentation with other biliary diseases; thus, the role of endoscopy is sometimes unclear, especially in altered anatomy. Radiological examinations may usually suspect it, but deeper examinations could be necessary to confirm it. Endoscopic retrograde cholangiopancreatography (ERCP) certainly has a therapeutic role in cases of jaundice, cholangitis or concurrent choledocolithiasis, although surgery is without doubt the definitive treatment in most of the cases. Therefore, surgeons may have a clearer picture of the condition of the biliary tree with respect to fistulas thanks to ERCP, particularly in patients with a higher grade of MS (type higher than 2 in the Csendes classification). Therefore, a complete removal of biliary stones is sometimes not possible due to size and location, so biliary stenting becomes the only option, even if transitory. Our brief report is a further demonstration of the fundamental role of ERCP in managing MS, even when it has no long-term therapeutic aim but is performed as bridge-to-surgery, especially in cases with a more difficult biliary anatomy due to the type of fistula. Moreover, we truly suggest discussing patients affected with MS in a multidisciplinary board, preferably in tertiary hepatobiliary centers. more...
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- 2024
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14. Contrast-enhanced endoscopic ultrasound and fine-needle biopsy of a rare mediastinal mass: a mediastinal schwannoma.
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Ligresti D, Quintini D, Tarantino I, Bertani A, Jukna A, Rizzo GEM, and Traina M
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- Humans, Biopsy, Fine-Needle, Mediastinal Neoplasms diagnostic imaging, Neurilemmoma diagnostic imaging, Neurilemmoma surgery
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
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- 2023
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15. Endoscopic treatment of a post-surgical dehiscence of an esophageal-ileal-colonic reconstruction: when endoscopy reaches its limit.
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Rizzo GEM, Carrozza L, Tammaro S, Ligresti D, Tarantino I, and Traina M
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- Humans, Endoscopy, Gastrointestinal, Surgical Wound Dehiscence therapy
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Competing Interests: The authors declare that they have no conflict of interest.
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- 2023
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16. Hemostatic matrix for treating intracollection bleeding after endoscopic ultrasound-guided drainage and endoscopic necrosectomy of walled-off pancreatic necrosis in a patient with cirrhosis.
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Rizzo GEM, Ligresti D, Carrozza L, Tammaro S, Traina M, and Tarantino I
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- Humans, Liver Cirrhosis, Ultrasonography, Interventional, Hemostatics, Pancreatitis, Acute Necrotizing
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
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- 2023
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17. Radiologic and endoscopic treatment for a disconnected pancreatic duct syndrome associated with percutaneous pancreatic fistula: achieving the "internalization of the fistula".
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Tarantino I, Carrozza L, Rizzo GEM, Tammaro S, Maruzzelli L, Ligresti D, and Traina M
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- Humans, Pancreatic Fistula, Pancreatic Ducts
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
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- 2023
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18. The Role of Endoscopy in the Palliation of Pancreatico-Biliary Cancers: Biliary Drainage, Management of Gastrointestinal Obstruction, and Role in Relief of Oncologic Pain.
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Rizzo GEM, Carrozza L, Rancatore G, Binda C, Fabbri C, Anderloni A, and Tarantino I
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Therapeutic endoscopy permits many and various treatments for cancer palliation in patients with bilio-pancreatic cancers, enabling different options, supporting patients during their route to oncologic treatments, and trying to improve their quality of life. Therefore, both endoscopic and endoscopic ultrasound (EUS)-guided techniques are performed in this scenario. We performed a literature review focusing on the role of endoscopy in the palliation of those advanced pancreatic and biliary cancers developing malignant biliary obstruction (MBO), gastric outlet obstruction (GOO), and pain unresponsive to medical therapies. Therefore, we explored and focused on the clinical outcomes of endoscopic procedures in this scenario. In fact, the endoscopic treatment is based on achieving biliary drainage in the case of MBO through endoscopic retrograde cholangiopancreatography (ERCP) or EUS-guided biliary drainage (EUS-BD), while GOO is endoscopically treated through the deployment of an enteral stent or the creation of EUS-guided gastro-entero-anastomosis (EUS-GEA). Furthermore, untreatable chronic abdominal pain is a major issue in patients unresponsive to high doses of painkillers, so EUS-guided celiac plexus neurolysis (CPN) or celiac ganglia neurolysis (CGN) helps to reduce dosage and have better pain control. Therefore, therapeutic endoscopy in the palliative setting is an effective and safe approach for managing most of the clinical manifestations of advanced biliopancreatic tumors. more...
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- 2023
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19. Successful multidisciplinary urgent management of life-threatening intraprocedural bleeding after EUS-guided fine-needle biopsy of a pulmonary mass.
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Rizzo GEM, Traina M, Carrozza L, Ligresti D, Bertani A, Tancredi G, Vitiello C, and Tarantino I
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Video 1Multidisciplinary management of an intraprocedural endobronchial bleeding after EUS-guided transesophageal FNB of a pulmonary mass., Competing Interests: Funded by the Italian Health Ministry, ricerca corrente 2023. The authors did not disclose any financial relationships., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.) more...
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- 2023
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20. A rare case of pedunculated ampulloma: EUS view and resection.
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Rizzo GEM, Ligresti D, Tarantino I, Barbaccia M, and Traina M
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Video 1Video showing a rare case of pedunculated ampulloma: imaging evaluation and resection technique., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)
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- 2023
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21. Balancing Efficacy and Tolerability of First-Line Systemic Therapies for Advanced Hepatocellular Carcinoma: A Network Meta-Analysis.
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Celsa C, Cabibbo G, Pinato DJ, Di Maria G, Enea M, Vaccaro M, Battaglia S, Rizzo GEM, Giuffrida P, Giacchetto CM, Rancatore G, Grassini MV, and Cammà C
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Background: Atezolizumab + bevacizumab represent the current standard of care for first-line treatment of advanced hepatocellular carcinoma (HCC). However, direct comparison with other combination treatments including immune checkpoint inhibitors (ICI) + tyrosine kinase inhibitors (TKIs) are lacking., Objectives: This network meta-analysis (NMA) aims to indirectly compare the efficacy and the safety of first-line systemic therapies for unresectable advanced HCC., Method: A literature search of MEDLINE, Embase, and SCOPUS databases was conducted up to October 31, 2022. Phase 3 randomized controlled trials (RCTs) testing TKIs, including sorafenib and lenvatinib, or ICIs reporting overall survival (OS) and progression-free survival (PFS) were included. Individual survival data were extracted from OS and PFS curves to calculate restricted mean survival time. A Bayesian NMA was performed to compare treatments in terms of efficacy (15- and 30-month OS, 6-month PFS) and safety, represented by grade ≥3 (severe) adverse events (SAEs). The incremental safety-effectiveness ratio as measure of net health benefit was calculated as the difference in SAE probability divided by survival difference between the 2 most effective treatments., Results: Nine RCTs enrolling 6,600 patients were included. Atezolizumab plus bevacizumab showed the highest probability (88%) of achieving the 30-month OS landmark. Lenvatinib showed a probability of 86% of achieving best PFS outcomes. ICI monotherapies ranked as most tolerable. Atezolizumab plus bevacizumab showed the best net health benefit for OS, compared to durvalumab plus tremelimumab. When evaluating the net health benefit for PFS, at a willingness-to-risk threshold of 10% of SAEs for life-month gained, atezolizumab plus bevacizumab was favoured in 78% of cases, while at threshold of 30% of SAEs for life-month gained, lenvatinib was favoured in 76% of cases., Conclusions: Atezolizumab plus bevacizumab is the best treatment in terms of net benefit and therefore it should be recommended as standard of care. Compared to atezolizumab plus bevacizumab, lenvatinib monotherapy had the best net benefit for PFS when physicians and patients are available to accept a higher risk of toxicity., Competing Interests: Giuseppe Cabibbo participated in advisory board for Bayer, Eisai, Ipsen, and AstraZeneca. Ciro Celsa received speaker fees from Eisai, Ipsen, and MSD. David James Pinato received lecture fees from BMS, Roche, and EISAI; travel expenses from BMS and Bayer Healthcare; consulting fees from Mina Therapeutics, EISAI, Roche, Da Volterra, Ewopharma, and AstraZeneca; research funding (to the institution) from MSD, GSK, and BMS; grant funding from the Wellcome Trust Strategic Fund (PS3416) and from the Associazione Italiana per la Ricerca sul Cancro (AIRC MFAG Grant ID 25697); and support from the NIHR Imperial Biomedical Research Centre, the Imperial Experimental Cancer Medicine Centre (ECMC), and the Imperial College Tissue Bank. Calogero Cammà participated in the advisory board for Bayer, MSD/Merck, Ipsen, AstraZeneca, Roche, and Eisai. The other authors have no disclosure to declare., (© 2023 The Author(s). Published by S. Karger AG, Basel.) more...
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- 2023
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22. Complete intraperitoneal maldeployment of a lumen-apposing metal stent during EUS-guided gastroenteroanastomosis for malignant gastric outlet obstruction: rescue retrieval with peritoneoscopy through natural orifice transluminal endoscopic surgery.
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Rizzo GEM, Carrozza L, Tammaro S, Ligresti D, Traina M, and Tarantino I
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Video 1Case showing a complete intraperitoneal maldeployment of a lumen-apposing metal stent during EUS-guided gastro-entero-anastomosis for malignant gastric outlet obstruction, which was rescued through a retrieval with peritoneoscopy through natural orifice transluminal endoscopic surgery., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.) more...
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- 2023
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23. A Systematic Review of Endoscopic Treatments for Concomitant Malignant Biliary Obstruction and Malignant Gastric Outlet Obstruction and the Outstanding Role of Endoscopic Ultrasound-Guided Therapies.
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Rizzo GEM, Carrozza L, Quintini D, Ligresti D, Traina M, and Tarantino I
- Abstract
Background: The treatments for cancer palliation in patients with concomitant malignant biliary obstruction (MBO) and gastric outlet obstruction (MGOO) are still under investigation due to the lack of evidence available in the medical literature. We performed a systematic search and critical review to investigate efficacy and safety among patients with MBO and MGOO undergoing both endoscopic ultrasound-guided biliary drainage (EUS-BD) and MGOO endoscopic treatment., Methods: A systematic literature search was performed in PubMed, MEDLINE, EMBASE, and the Cochrane Library. EUS-BD included both transduodenal and transgastric techniques. Treatment of MGOO included duodenal stenting or EUS-GEA (gastroenteroanastomosis). Outcomes of interest were technical success, clinical success, and rate of adverse events (AEs) in patients undergoing double treatment in the same session or within one week., Results: 11 studies were included in the systematic review for a total number of 337 patients, 150 of whom had concurrent MBO and MGOO treatment, fulfilling the time criteria. MGOO was treated by duodenal stenting (self-expandable metal stents) in 10 studies, and in one study by EUS-GEA. EUS-BD had a mean technical success of 96.4% (CI 95%, 92.18-98.99) and a mean clinical success of 84.96% (CI 95%, 67.99-96.26). The average frequency of AEs for EUS-BD was 28.73% (CI 95%, 9.12-48.33). Clinical success for duodenal stenting was 90% vs. 100% for EUS-GEA., Conclusions: EUS-BD could become the preferred drainage in the case of double endoscopic treatment of concomitant MBO and MGOO in the near future, with the promising EUS-GEA becoming a valid option for MGOO treatment in these patients. more...
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- 2023
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24. Trans-cavity lumen-apposing metal stent removal: an alternative safe modality.
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Rizzo GEM and Tarantino I
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- 2023
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25. Endoscopic percutaneous drainage in a COVID-19 patient with iatrogenic gastric perforation.
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Granata A, Martucci G, Rizzo GEM, Ligresti D, Arcadipane A, and Traina M
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- Humans, Drainage, Endoscopy, Iatrogenic Disease, COVID-19, Stomach Diseases, Intestinal Perforation
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
- Published
- 2022
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26. A surprising case of a biliary tumor-like lesion.
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Rizzo GEM, Maruzzelli L, Liotta R, Miraglia R, Gruttadauria S, Traina M, and Tarantino I
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- Humans, Bile Ducts, Intrahepatic pathology, Bile Duct Neoplasms diagnostic imaging, Bile Duct Neoplasms surgery, Biliary Tract
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
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- 2022
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27. Hepatitis B Virus-Associated Hepatocellular Carcinoma.
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Rizzo GEM, Cabibbo G, and Craxì A
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- Hepatitis B virus genetics, Humans, Liver Cirrhosis complications, Tumor Microenvironment, Carcinoma, Hepatocellular pathology, Hepatitis B complications, Liver Neoplasms genetics
- Abstract
Hepatitis B virus (HBV) is DNA-based virus, member of the Hepadnaviridae family, which can cause liver disease and increased risk of hepatocellular carcinoma (HCC) in infected individuals, replicating within the hepatocytes and interacting with several cellular proteins. Chronic hepatitis B can progressively lead to liver cirrhosis, which is an independent risk factor for HCC. Complications as liver decompensation or HCC impact the survival of HBV patients and concurrent HDV infection worsens the disease. The available data provide evidence that HBV infection is associated with the risk of developing HCC with or without an underlying liver cirrhosis, due to various direct and indirect mechanisms promoting hepatocarcinogenesis. The molecular profile of HBV-HCC is extensively and continuously under study, and it is the result of altered molecular pathways, which modify the microenvironment and lead to DNA damage. HBV produces the protein HBx, which has a central role in the oncogenetic process. Furthermore, the molecular profile of HBV-HCC was recently discerned from that of HDV-HCC, despite the obligatory dependence of HDV on HBV. Proper management of the underlying HBV-related liver disease is fundamental, including HCC surveillance, viral suppression, and application of adequate predictive models. When HBV-HCC occurs, liver function and HCC characteristics guide the physician among treatment strategies but always considering the viral etiology in the treatment choice. more...
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- 2022
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28. Endoscopic Treatment of Iatrogenic Perforation of Sigmoid Diverticulum: A Case Report of Multidisciplinary Management.
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Rizzo GEM, Ferro G, Rizzo G, Carlo GD, Cantone A, Vita GGD, and Sciumè C
- Abstract
Iatrogenic perforations are severe complications of gastrointestinal endoscopy; therefore, their management should be adequately planned. A 77-year-old man with a history of diverticulosis underwent a colonoscopy for anemia. During the procedure, an iatrogenic perforation occurred suddenly in the sigmoid colon, near a severe angle among the numerous diverticula. Through-the-scope clips were immediately applied to treat it and close mucosal edges. Laboratory tests showed increased levels of inflammation and infection, and although there were no complaints of abdominal pain, the patient had an extremely distended abdomen. A multidisciplinary board began management based on a conservative approach. Pneumoperitoneum was treated with computed tomography-assisted drainage. After 72 hours, his intestinal canalization and laboratory tests were normal. Though this adverse event is rare, a multidisciplinary board should be promptly gathered upon occurrence, even if the patient appears clinically stable, to consider a conservative approach and avoid surgical treatment. more...
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- 2022
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29. Hepatocellular carcinoma recurrence after direct-acting antiviral therapy: an individual patient data meta-analysis.
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Sapena V, Enea M, Torres F, Celsa C, Rios J, Rizzo GEM, Nahon P, Mariño Z, Tateishi R, Minami T, Sangiovanni A, Forns X, Toyoda H, Brillanti S, Conti F, Degasperi E, Yu ML, Tsai PC, Jean K, El Kassas M, Shousha HI, Omar A, Zavaglia C, Nagata H, Nakagawa M, Asahina Y, Singal AG, Murphy C, Kohla M, Masetti C, Dufour JF, Merchante N, Cavalletto L, Chemello LL, Pol S, Crespo J, Calleja JL, Villani R, Serviddio G, Zanetto A, Shalaby S, Russo FP, Bielen R, Trevisani F, Cammà C, Bruix J, Cabibbo G, and Reig M more...
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- Humans, Neoplasm Recurrence, Local diagnosis, Propensity Score, Antiviral Agents therapeutic use, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular therapy, Liver Neoplasms epidemiology, Liver Neoplasms therapy, Neoplasm Recurrence, Local epidemiology
- Abstract
Objective: The benefit of direct-acting antivirals (DAAs) against HCV following successful treatment of hepatocellular carcinoma (HCC) remains controversial. This meta-analysis of individual patient data assessed HCC recurrence risk following DAA administration., Design: We pooled the data of 977 consecutive patients from 21 studies of HCV-related cirrhosis and HCC, who achieved complete radiological response after surgical/locoregional treatments and received DAAs (DAA group). Recurrence or death risk was expressed as HCC recurrence or death per 100 person-years (100PY). Propensity score-matched patients from the ITA.LI.CA. cohort (n=328) served as DAA-unexposed controls (no-DAA group). Risk factors for HCC recurrence were identified using random-effects Poisson., Results: Recurrence rate and death risk per 100PY in DAA-treated patients were 20 (95% CI 13.9 to 29.8, I
2 =74.6%) and 5.7 (2.5 to 15.3, I2 =54.3), respectively. Predictive factors for recurrence were alpha-fetoprotein logarithm (relative risk (RR)=1.11, 95% CI 1.03 to 1.19; p=0.01, per 1 log of ng/mL), HCC recurrence history pre-DAA initiation (RR=1.11, 95% CI 1.07 to 1.16; p<0.001), performance status (2 vs 0, RR=4.35, 95% CI 1.54 to 11.11; 2 vs 1, RR=3.7, 95% CI 1.3 to 11.11; p=0.01) and tumour burden pre-HCC treatment (multifocal vs solitary nodule, RR=1.75, 95% CI 1.25 to 2.43; p<0.001). No significant difference was observed in RR between the DAA-exposed and DAA-unexposed groups in propensity score-matched patients (RR=0.64, 95% CI 0.37 to 1.1; p=0.1)., Conclusion: Effects of DAA exposure on HCC recurrence risk remain inconclusive. Active clinical and radiological follow-up of patients with HCC after HCV eradication with DAA is justified., Competing Interests: Competing interests: VS: travel funding from Bayer. FT: DSMB fees from Basilea Pharmaceutica International and ROVI; educational fees from Janssen and Ferrer. PN: consults for AbbVie, AstraZeneca, Bayer, BMS, Eisai, Gilead, Ipsen, Roche. He received grants from AbbVie and BMS. ZM: speaker fees and consultancy for Gilead and AbbVie. RT: personal fees from Merk Sharp & Dorme, Giliad Sciences and AbbVie GK. TM: personal fees from Merk Sharp & Dorme, Giliad Sciences and AbbVie GK. XF: consultancy fees for AbbVie and Gilead Sciences. HT: speaker fees from AbbVie, Gildead, MSD and Bayer. SB: consultancy fees and educational grants from: Gilead Sciences, MSD, Intercept. ED: advisory board from AbbVie; speaking and teaching from Gilead, MSD, AbbVie. M-LY: research grant from Abbott, BMS, Gilead and Merck; consultant of AbbVie, Abbott, BMS, Gilead, Merck and Roche; speaker of AbbVie, Abbott, BMS, Gilead and Merck. YA: donation-funded department funded by Toray Industries Inc., Gilead Sciences, AbbVie GK and Fuji Rebio Inc. AS: has received research funding from AbbVie and Gilead. He has served as a consultant for Wako Diagnostics, Glycotest, Exact Sciences, Roche, GRAIL, Genentech, Bayer, Eisai, Exelixis, AstraZeneca, BMS and TARGET Pharmasolutions. MK: lecture fees from Abott and AstraZeneca. J-FD: advisory committees: AbbVie, Bayer, Bristol-Myers Squibb, Falk, Genfit, Genkyotex, Gilead Sciences, HepaRegenix, Intercept, Lilly, Merck, Novartis. Speaking and teaching: Bayer, Bristol-Myers Squibb, Intercept, Genfit, Gilead Sciences, Novartis, Roche. NM: research founding, lecture fees, advisory committees and travel grants from MSD. Lecture fees, advisory committees and travel grants from AbbVie and Gilead. SP: consulting and lecturing fees from Janssen, Gilead, MSD, AbbVie, Biotest, Shinogui, Viiv and grants from Bristol-Myers Squibb, Gilead, Roche and MSD, without relation to this manuscript. JC: grants and research support from Gilead Sciences, AbbVie, MSD, Shionogi and Intercept Pharmaceuticals (all outside the submitted work). Is a speaker for Gilead Sciences and AbbVie. JLC: reports grant support and/or consultancy and lecture fees from AbbVie, Gilead Sciences, Bristol-Myers Squibb, Janssen and MSD. RV: research grant from AbbVie. GS: consultancy fees and lecture fees from Gilead and AbbVie. FPR: lecture fees AbbVie, Gilead, MSD, Biotest; travel funds AbbVie, Biotest, Kedrion; research funds AbbVie, Gilead, MSD. RB: research grants from MSD, AbbVie and Gilead. JR: educational grants from Amgen, Grüenenthal Pharma, Boehringer Ingelheim España, Janssen-Cilag, Ferrer International, Lilly, Merck Sharp & Dohme and Roche Farma. FT: consultancy fees from AstraZeneca, Bayer, BMS, Eisai and Sirtex. Lecture fees from AlfaSigma and Bayer. Research grants from Bayer. CC: consultancy fees from Bayer, EISAI, MSD, Gilead, ABV. JB: consultancy fees from Arqule, Bayer, Novartis, BMS, BTG-Biocompatibles, Eisai, Kowa, Terumo, Gilead, Bio-Alliance/Onxeo, Roche, AbbVie, Merck, Sirtex, Ipsen, Astra-Medimmune, Incyte, Quirem, Adaptimmune, Lilly, Basilea, Nerviano. Research grants from Bayer and BTG. Educational grants from Bayer and BTG. Lecture fees from Bayer, BTG-Biocompatibles, Eisai, Terumo, Sirtex, Ipsen. GC: consultancy fees from Bayer, Ipsen. MR: consultancy fees from Bayer, BMS, Roche, Ipsen, AstraZeneca and Lilly. Lecture fees from Bayer, BMS, Gilead, Lilly and Roche. Research grants from Bayer and Ipsen., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.) more...- Published
- 2022
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30. Combined endoscopical treatments for tracheo-esophageal fistula developed during V-V ECMO for severe COVID-19: A case series.
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Granata A, Martucci G, Rizzo GEM, Arcadipane A, and Traina M
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Tracheoesophageal Fistula etiology, COVID-19 complications, Endoscopy methods, Extracorporeal Membrane Oxygenation, Tracheoesophageal Fistula surgery, Tracheostomy adverse effects
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- 2022
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31. First-Line Immune Checkpoint Inhibitor-Based Sequential Therapies for Advanced Hepatocellular Carcinoma: Rationale for Future Trials.
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Cabibbo G, Reig M, Celsa C, Torres F, Battaglia S, Enea M, Rizzo GEM, Petta S, Calvaruso V, Di Marco V, Craxì A, Singal AG, Bruix J, and Cammà C
- Abstract
Introduction: Atezolizumab (ATEZO) plus bevacizumab (BEVA) represents the new standard of care for the treatment of advanced hepatocellular carcinoma (HCC). However, the choice of the second-line treatment after the failure of immunotherapy-based first-line remains elusive. Taking into account the weaknesses of the available evidence, we developed a simulation model based on available phase III randomized clinical trials (RCTs) to identify optimal risk/benefit sequential strategies., Methods: A Markov model was built to estimate the overall survival (OS) of sequential first- and second-line systemic treatments. Sequences starting with first-line ATEZO plus BEVA followed by 5 second-line treatments (sorafenib [SORA], lenvatinib [LENVA], regorafenib, cabozantinib, and ramucirumab) were compared. The probability of transition between states (initial treatment, cancer progression, and death) was derived from RCTs. Life-year gained (LYG) was the main outcome. Rates of severe adverse events (SAEs) (≥ grade 3) were calculated. The incremental safety-effectiveness ratio (ISER) was calculated as the difference in probability of SAEs divided by LYG between the 2 most effective sequences., Results: ATEZO plus BEVA followed by LENVA (median OS, 24 months) or SORA (median OS, 23 months) was the most effective sequence, producing a LYG of 0.50 and 0.42 year, respectively. ATEZO plus BEVA followed by SORA was the safest sequence (SAEs 63%). At a willingness-to-risk threshold of 10% of SAEs for LYG, ATEZO plus BEVA followed by second-line SORA was favored in 72% of cases, while at a threshold of 30% of SAEs for LYG, ATEZO plus BEVA followed by second-line LENVA was favored in 69% of cases., Conclusion: Our simulation model provides a strong rationale to support ongoing trials evaluating second-line tyrosine-kinase inhibitors after first-line ATEZO plus BEVA. Future evidence from ongoing RCTs and prospective real-world studies are needed to prove the net health benefit of sequential treatment options for advanced HCC., Competing Interests: Giuseppe Cabibbo participated in advisory board for Bayer, Eisai, and Ipsen. Maria Reig is a consultant at Bayer-Shering Pharma, BMS, Roche, Ipsen, AstraZeneca, Lilly, and BTG; attended paid conferences at Bayer-Shering Pharma, BMS, Gilead, and Lilly; received research grants from Bayer-Shering Pharma and Ipsen. Ciro Celsa received speaker fees from Eisai. Amit Singal served on advisory boards or as consultant for Genentech, Bayer, Eisai, Exelixis, Bristol Myers Squibb, and AstraZeneca. Jordi Bruix is a consultant at AbbVie, Adaptimmune, Arqule, Astra-Medimmune, Basilea, Bayer-Shering Pharma, Bio-Alliance, BMS, BTG-Biocompatibles, Eisai, Gilead, Incyte, Ipsen, Kowa, Lilly, MSD, Nerviano, Novartis, Polaris, Quirem, Roche, Sirtex, Sanofi, and Terumo; received research grants from Bayer and BTG; received educational grants from Bayer and BTG; attended paid conferences at Bayer, BTG, Astra-Zeneca, and Ipsen; gave paid talks at Bayer-Shering Pharma, BTG-Biocompatibles, Eisai, Terumo, Sirtex, and Ipsen. Calogero Cammà participated in the advisory board for Bayer, MSD/Merck, Ipsen, and Eisai. The other authors have no disclosure to declare., (Copyright © 2021 by S. Karger AG, Basel.) more...
- Published
- 2021
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32. Biliopancreatic Endoscopy in Altered Anatomy.
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Tarantino I and Rizzo GEM
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- Gastrectomy, Humans, Prospective Studies, Retrospective Studies, Cholangiopancreatography, Endoscopic Retrograde, Endosonography
- Abstract
Background and Objectives : Anatomical post-surgical alterations of the upper gastrointestinal (GI) tract have always been challenging for performing diagnostic and therapeutic endoscopy, especially when biliopancreatic diseases are involved. Esophagectomy, gastrectomy with various reconstructions and pancreaticoduodenectomy are among the most common surgeries causing upper GI tract alterations. Technological improvements and new methods have increased the endoscopic success rate in these patients, and the literature has been rapidly increasing over the past few years. The aim of this systematic review is to identify evidence on the available biliopancreatic endoscopic techniques performed in the altered post-surgical anatomy of upper GI tract. Materials and Methods : We performed a systematic search of PubMed, MEDLINE, Cochrane Library, and SCOPUS databases. Study-level variables extracted were the last name of the first author, publication year, study design, number of patients, type of post-surgical anatomical alteration, endoscopic technique, success rate and endoscopic-related adverse events. Results : Our primary search identified 221 titles, which was expanded with studies after the citation search. The final full-text review process identified 52 articles (31 retrospective studies, 8 prospective studies and 13 case reports). We found several different techniques developed over the years for biliopancreatic diseases in altered anatomy, in order to perform both endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP). They included enteroscopy-assisted ERCP (double and single balloon enteroscopy-ERCP, spiral enteroscopy-ERCP) laparoscopic assisted ERCP, EUS-Directed transgastric ERCP, EUS-directed transgastric intervention, gastric access temporary for endoscopy, and percutaneous assisted trans prosthetic endoscopic therapy. The success rate was high (most of the techniques showed a success rate over 90%) and a low rate of adverse events were reported. Conclusions : We suggest the considerationof the novel techniques when approaching patients with altered anatomy who require biliopancreatic endoscopy, focusing on the surgery type, success rate and adverse events reported in the literature. more...
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- 2021
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33. Systemic therapies for hepatocellular carcinoma: the present and the future.
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Celsa C, Giuffrida P, Stornello C, Grova M, Spatola F, Rizzo GEM, Busacca A, Cannella R, Battaglia S, Cammà C, and Cabibbo G
- Subjects
- Humans, Immunotherapy, Nivolumab, Sorafenib therapeutic use, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular pathology, Liver Neoplasms drug therapy, Liver Neoplasms pathology
- Abstract
Hepatocellular carcinoma is diagnosed in more than half of all cases at unresectable stage when no potentially curative treatments are feasible. Since 2008, sorafenib had represented the only effective first line systemic therapy over the last decade until the approval of lenvatinib, who showed to be non-inferior to sorafenib. Recently, for the first time, a combination of immunotherapy and antiangiogenic drug, atezolizumab plus bevacizumab, was associated with a significantly longer overall survival and progression free survival compared to sorafenib, becoming the new best performing first-line approach for unresectable HCC. After several randomized controlled trials (RCTs) that have attempted to find an effective second-line therapy, regorafenib, cabozantinib, ramucirumab, nivolumab and pembrolizumab represent approved treatments for patients who failed first-line treatment. However, inclusion criteria of second-line RCTs are quite heterogeneous and no direct comparisons exist among these agents. Exciting opportunities have been found either in the combination or in the sequencing of these agents, but the optimal therapeutic strategy for these patients remains elusive. Moreover, the coexistence of cirrhosis and the competing risk of liver decompensation increase the complexity of the assessment of the net health benefit of the available therapeutic approaches. The aim of this review is to summarize the evidence on systemic treatments for unresectable HCC and to explore the future perspectives on this topic. more...
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- 2021
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34. SARS-CoV-2 infection in patients with a normal or abnormal liver.
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Cabibbo G, Rizzo GEM, Stornello C, and Craxì A
- Subjects
- COVID-19 epidemiology, COVID-19 prevention & control, COVID-19 therapy, COVID-19 Vaccines administration & dosage, Chronic Disease, Humans, Liver virology, Liver Cirrhosis complications, Liver Cirrhosis epidemiology, Liver Cirrhosis therapy, Liver Diseases epidemiology, Liver Diseases therapy, Risk, COVID-19 complications, Liver injuries, Liver Diseases complications, SARS-CoV-2 pathogenicity
- Abstract
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), a novel coronavirus causing coronavirus disease 19 (COVID-19), with an estimated 22 million people infected worldwide so far although involving primarily the respiratory tract, has a remarkable tropism for the liver and the biliary tract. Patients with SARS-CoV-2 infection and no antecedent liver disease may display evidence of cytolytic liver damage, proportional to the severity of COVID-19 but rarely of clinical significance. The mechanism of hepatocellular injury is unclear and possibly multifactorial. The clinical impact of SARS-CoV-2 infection in patients with underlying chronic liver disease, a cohort whose global size is difficult to estimate, has been assessed appropriately only recently and data are still evolving. Patients with cirrhosis are at higher risk of developing severe COVID-19 and worse liver-related outcomes as compared to those with non-cirrhotic liver disease. OLT patients have an intermediate risk. Specific interventions in order to reduce the risk of transmission of infection among this high-risk population have been outlined by international societies, together with recommendations for modified treatment and follow-up regimens during the COVID-19 pandemic. When a vaccine against SARS-CoV-2 becomes available, patients with fibrotic liver disease and those with OLT should be considered as prime targets for prophylaxis of COVID-19, as all other highly susceptible subjects., (© 2020 John Wiley & Sons Ltd.) more...
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- 2021
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35. Progression-Free Survival Early Assessment Is a Robust Surrogate Endpoint of Overall Survival in Immunotherapy Trials of Hepatocellular Carcinoma.
- Author
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Cabibbo G, Celsa C, Enea M, Battaglia S, Rizzo GEM, Busacca A, Matranga D, Attanasio M, Reig M, Craxì A, and Cammà C
- Abstract
Background: Radiology-based outcomes, such as progression-free survival (PFS) and objective response rate (ORR), are used as surrogate endpoints in oncology trials. We aimed to assess the surrogacy relationship of PFS with overall survival (OS) in clinical trials of systemic therapies targeting advanced hepatocellular carcinoma (HCC) by novel meta-regression methods., Methods: A search of databases (PubMed, American Society of Clinical Oncology (ASCO), and European Society for Medical Oncology (ESMO) Meeting Libraries, Clinicaltrials.gov) for trials of systemic therapies for advanced HCC reporting both OS and PFS was performed. Individual patient data were extracted from PFS and OS Kaplan-Meier curves. Summary median PFS and OS data were obtained from random-effect model. The surrogate relationships of median PFS, first quartile (Q1), third quartile (Q3), and restricted mean survival time (RMST) for OS were evaluated by the coefficient of determination R
2 . Heterogeneity was explored by meta-regression., Results: We identified 49 trials, 11 assessing immune-checkpoint inhibitors (ICIs) and 38 multikinase inhibitors (MKIs). Overall, the correlation between median PFS and median OS was weak (R2 = 0.20. 95% Confidence Intervals [CI]-0.02;0.42). Surrogacy robustness varied between treatment classes and PFS endpoints. In ICI trials only, the correlations between Q1-PFS and Q1-OS and between 12-month PFS-RMST and 12-month OS-RMST were high (R2 = 0.89, 95%CI 0.78-0.98, and 0.80, 95% CI 0.63-0.96, respectively). Interaction p -values obtained by meta-regression confirmed the robustness of results., Conclusions: In trials of systemic therapies for advanced HCC, the surrogate relationship of PFS with OS is highly variable depending on treatment class (ICI or MKI) and evaluation time-point. In ICI trials, Q1-PFS and 12-month PFS-RMST are robust surrogate endpoints for OS. more...- Published
- 2020
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36. Optimizing Sequential Systemic Therapies for Advanced Hepatocellular Carcinoma: A Decision Analysis.
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Cabibbo G, Celsa C, Enea M, Battaglia S, Rizzo GEM, Grimaudo S, Matranga D, Attanasio M, Bruzzi P, Craxì A, and Cammà C
- Abstract
Background: An optimal sequential systemic therapy for advanced hepatocellular carcinoma (HCC) has not been discovered. We developed a decision model based on available clinical trials to identify an optimal risk/benefit strategy for sequences of novel systemic agents. Methods: A Markov model was built to simulate overall survival (OS) among patients with advanced HCC. Three first-line (single-agent Sorafenib or Lenvatinib, and combination of Atezolizumab plus Bevacizumab) followed by five second-line treatments (Regorafenib, Cabozantinib, Ramucirumab, Nivolumab, Pembrolizumab) were compared in fifteen sequential strategies. The likelihood of transition between states (initial treatment, cancer progression, death) was derived from clinical trials. Life-year gained (LYG) was the main outcome. Rates of severe adverse events (SAEs) (≥grade 3) were calculated. The innovative measure, called incremental safety-effectiveness ratio (ISER), of the two best sequential treatments was calculated as the difference in probability of SAEs divided by LYG. Results: Lenvatinib followed by Nivolumab (median OS, 27 months) was the most effective sequence, producing a LYG of 0.75, while Atezolizumab plus Bevacizumab followed by Nivolumab was the safest sequence (SAEs 40%). Accordingly, the net health benefit assessed by ISER favored Lenvatinib followed by Nivolumab, compared to Atezolizumab plus Bevacizumab, followed by Nivolumab in 52% of cases. Conclusion : Further sequential clinical trials or large-scale real-world studies may prove useful to evaluate the net health benefit of the best sequential treatment for advanced HCC. more...
- Published
- 2020
- Full Text
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