Alessandro Fugazza1, Carlo Fabbri2, Roberto Di Mitri3, Maria Chiara Petrone4, Matteo Colombo1, Luigi Cugia5, Arnaldo Amato6, Edoardo Forti7, Cecilia Binda2, Marcello Maida8, Emanuele Sinagra9, Alessandro Repici10, Ilaria Tarantino11, Andrea Anderloni1. 1. Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital-IRCCS, Milan, Italy. 2. Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, AUSL Romagna, Forlì-Cesena, Italy. 3. Gastroenterology and Endoscopy Unit, ARNAS Civico Hospital, Palermo, Italy. 4. Pancreato-Biliary Endoscopy and EUS Division, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute IRCCS, Milan, Italy. 5. Division of Gastroenterology and Digestive Endoscopy (Department of Emergency), Azienda Ospedaliero Universitaria Sassari, Sassari, Italy. 6. Department of Gastroenterology, Valduce Hospital, Como, Italy. 7. Digestive and Interventional Endoscopy Unit, Ospedale Ca'Granda Niguarda, Milan, Italy. 8. Gastroenterology and Endoscopy Unit, S Elia-Raimondi Hospital, Caltanissetta, Italy. 9. Gastroenterology & Endoscopy Unit, Fondazione Istituto G Giglio, Cefalù, Italy. 10. Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital-IRCCS, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy. 11. Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy.
Abstract
BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) has been proposed as an alternative procedure in patients with distal malignant biliary obstruction (DMBO) and failed ERCP. METHODS: This multicenter, retrospective analysis included all cases of EUS-CDS with LAMS performed in patients with DMBO and failed ERCP in 23 Italian centers from January 2016 to July 2020. Primary endpoints were technical and clinical success. Secondary endpoints were the assessment of the adverse event (AE) rate and variables associated with technical success. RESULTS: Two hundred fifty-six patients (44.9% women) with a mean age of 73.9 ± 12.6 years were included in the study. The most common etiology of DMBO was pancreatic adenocarcinoma (75%), followed by ampullary cancer (8.6%) and cholangiocarcinoma (6.6%). The common bile duct median diameter was 17.3 ± 3.9 mm. Technical and clinical success were achieved in 239 of 256 (93.3%), and 230 of 239 (96.2%) patients, respectively. The mean follow-up was 151 ± 162 days. Twenty-seven AEs occurred in 25 of 239 patients (10.5%) (3 mild, 21 moderate, and 3 severe). No fatal AEs occurred. Reinterventions to manage AEs with endoscopic or radiologic procedures occurred in 22 patients (9.2%). CONCLUSIONS: The results of our study show that EUS-CDS with LAMSs in patients with DMBO and failed ERCP represent a viable alternative in terms of effectiveness and safety with acceptable AE rates. (Clinical trial registration number: NCT03903523.).
BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) has been proposed as an alternative procedure in patients with distal malignant biliary obstruction (DMBO) and failed ERCP. METHODS: This multicenter, retrospective analysis included all cases of EUS-CDS with LAMS performed in patients with DMBO and failed ERCP in 23 Italian centers from January 2016 to July 2020. Primary endpoints were technical and clinical success. Secondary endpoints were the assessment of the adverse event (AE) rate and variables associated with technical success. RESULTS: Two hundred fifty-six patients (44.9% women) with a mean age of 73.9 ± 12.6 years were included in the study. The most common etiology of DMBO was pancreatic adenocarcinoma (75%), followed by ampullary cancer (8.6%) and cholangiocarcinoma (6.6%). The common bile duct median diameter was 17.3 ± 3.9 mm. Technical and clinical success were achieved in 239 of 256 (93.3%), and 230 of 239 (96.2%) patients, respectively. The mean follow-up was 151 ± 162 days. Twenty-seven AEs occurred in 25 of 239 patients (10.5%) (3 mild, 21 moderate, and 3 severe). No fatal AEs occurred. Reinterventions to manage AEs with endoscopic or radiologic procedures occurred in 22 patients (9.2%). CONCLUSIONS: The results of our study show that EUS-CDS with LAMSs in patients with DMBO and failed ERCP represent a viable alternative in terms of effectiveness and safety with acceptable AE rates. (Clinical trial registration number: NCT03903523.).
Authors: Giuseppe Vanella; Giuseppe Dell'Anna; Michiel Bronswijk; Roy L J van Wanrooij; Gianenrico Rizzatti; Paraskevas Gkolfakis; Alberto Larghi; Schalk van der Merwe; Paolo Giorgio Arcidiacono Journal: Ann Gastroenterol Date: 2022-07-15