Andrea Anderloni1, Carlo Fabbri2, Jose Nieto3, Will Uwe4, Markus Dollhopf5, José Ramón Aparicio6, Manuel Perez-Miranda7, Ilaria Tarantino8, Alexander Arlt9, Frank Vleggaar10, Geoffrey Vanbiervliet11, Jochen Hampe12, Michel Kahaleh13, Juan J Vila14, Barham K Abu Dayyeh15, Andrew C Storm15, Alessandro Fugazza16, Cecilia Binda2, Antoine Charachon17, Sergio Sevilla-Ribota7, Amy Tyberg13, Moran Robert18, Sachin Wani19, Alessandro Repici16,20, Amrita Sethi21, Mouen A Khashab18, Rastislav Kunda22,23. 1. Digestive Endoscopy Unit, Humanitas Clinical and Research Center - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy. andrea.anderloni@humanitas.it. 2. Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, AUSL Romagna, Forlì-Cesena, Italy. 3. Advanced Therapeutic Endoscopy Center Borland Groover Clinic, Jacksonville, FL, USA. 4. Department of Gastroenterology, Municipal Hospital, Gera, Germany. 5. Department of Gastroenterology, Klinikum Neuperlach, Munich, Germany. 6. Endoscopy Unit, Digestive Service, Alicante University General Hospital, Alicante, Spain. 7. Gastroenterology & Hepatology Hospital Universitario Rio Hortega, Valladolid, Spain. 8. Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy. 9. Department of Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University Kiel, Kiel Campus, Kiel, Germany. 10. Department of Gastroenterology and Hepatology, University Medical Center, Utrecht, Netherlands. 11. Digestive Endoscopy Unit, l'Archet University Hospital, Nice, France. 12. Medical Department 1, University Hospital Dresden, Technische Universität Dresden (TU Dresden), Dresden, Germany. 13. Weill Cornell Medical, New York, NY, USA. 14. Endoscopy Unit, Complejo Hospitalario de Navarra, Pamplona, Spain. 15. Division of Gastroenterology and Hepatology, Mayo Clinic Alix School of Medicine, 200 First Street SW, Rochester, MN, 55905, USA. 16. Digestive Endoscopy Unit, Humanitas Clinical and Research Center - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy. 17. Service d'Hépato-gastro-entérologie, CH Princesse Grace, Monaco, Monaco. 18. Therapeutic Endoscopy, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, USA. 19. Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. 20. Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy. 21. Pancreaticobiliary Endoscopy Services Division of Digestive and Liver Disease, Columbia University Medical Center-NYPH, New York, NY, USA. 22. Department of Surgical Gastroenterology, Aarhus University Hospital, Aarhus, Denmark. 23. Department of Surgery, Department of Gastroenterology-Hepatology, Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
Abstract
BACKGROUND: Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date. METHODS: This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events. RESULTS: A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction. CONCLUSIONS: This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.
BACKGROUND:Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date. METHODS: This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events. RESULTS: A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patientsdied due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction. CONCLUSIONS: This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.
Authors: Gabriel D Lang; Cassandra Fritz; Trisha Bhat; Koushik K Das; Faris M Murad; Dayna S Early; Steven A Edmundowicz; Vladimir M Kushnir; Daniel K Mullady Journal: Gastrointest Endosc Date: 2017-07-14 Impact factor: 9.427
Authors: Daisy Walter; Uwe Will; Andres Sanchez-Yague; Dirk Brenke; Jochen Hampe; Helge Wollny; Jose Miguel Esteban López-Jamar; Gertrud Jechart; Peter Vilmann; Joan B Gornals; Sebastian Ullrich; Martin Fähndrich; Alberto Herreros de Tejada; Félix Junquera; Ferran Gonzalez-Huix; Peter D Siersema; Frank P Vleggaar Journal: Endoscopy Date: 2014-09-30 Impact factor: 10.093
Authors: Ali A Siddiqui; Douglas G Adler; Jose Nieto; Janak N Shah; Kenneth F Binmoeller; Steve Kane; Linda Yan; Sobia N Laique; Thomas Kowalski; David E Loren; Linda Jo Taylor; Satish Munigala; Yasser M Bhat Journal: Gastrointest Endosc Date: 2015-10-26 Impact factor: 9.427
Authors: Barham K Abu Dayyeh; Saurabh Mukewar; Shounak Majumder; Raja Zaghlol; Eric J Vargas Valls; Fateh Bazerbachi; Michael J Levy; Todd H Baron; Christopher J Gostout; Bret T Petersen; John Martin; Ferga C Gleeson; Randall K Pearson; Suresh T Chari; Santhi S Vege; Mark D Topazian Journal: Gastrointest Endosc Date: 2017-05-03 Impact factor: 9.427
Authors: Ali A Siddiqui; Thomas E Kowalski; David E Loren; Ammara Khalid; Ayesha Soomro; Syed M Mazhar; Laura Isby; Michel Kahaleh; Kunal Karia; Joseph Yoo; Andrew Ofosu; Beverly Ng; Reem Z Sharaiha Journal: Gastrointest Endosc Date: 2016-08-24 Impact factor: 9.427
Authors: Reem Z Sharaiha; Amy Tyberg; Mouen A Khashab; Nikhil A Kumta; Kunal Karia; Jose Nieto; Uzma D Siddiqui; Irving Waxman; Virendra Joshi; Petros C Benias; Peter Darwin; Christopher J DiMaio; Christopher J Mulder; Shai Friedland; David G Forcione; Divyesh V Sejpal; Tamas A Gonda; Frank G Gress; Monica Gaidhane; Ann Koons; Ersilia M DeFilippis; Sanjay Salgado; Kristen R Weaver; John M Poneros; Amrita Sethi; Sammy Ho; Vivek Kumbhari; Vikesh K Singh; Alan H Tieu; Viviana Parra; Alisa Likhitsup; Craig Womeldorph; Brenna Casey; Sreeni S Jonnalagadda; Amit P Desai; David L Carr-Locke; Michel Kahaleh; Ali A Siddiqui Journal: Clin Gastroenterol Hepatol Date: 2016-05-14 Impact factor: 11.382
Authors: Ji Young Bang; Udayakumar Navaneethan; Muhammad K Hasan; Bryce Sutton; Robert Hawes; Shyam Varadarajulu Journal: Gut Date: 2018-06-01 Impact factor: 23.059