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Title: | Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial) |
Author: | Schmitz, Daniel Valiente, Carlos T. Dollhopf, Markus Pérez Miranda, Manuel Küllmer, Armin Gornals, Joan Vila, Juan Weigt, Jochen Voigtländer, Torsten Redondo Cerezo, Eduardo Von Hahn, Thomas Albert, Jörg Vom Dahl, Stephan Beyna, Torsten Hartmann, Dirk Franck, Franziska García Alonso, Francisco Javier Schmidt, Arthur Garcia Sumalla, Albert Arrubla, Amaia Joerdens, Markus Kleemann, Tobias Aparicio Tomo, José Ramón Grassmann, Felix Rudi, Jochen |
Keywords: | Assaigs clínics Colèstasi Endoscòpia Conductes biliars Clinical trials Cholestasis Endoscopy Bile ducts |
Issue Date: | 27-Oct-2022 |
Publisher: | Public Library of Science (PLoS) |
Abstract: | Background Endoscopic ultrasound-guided biliary drainage (EUS-BD) was associated with better clinical success and a lower rate of adverse events (AEs) than fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent single center studies with mainly retrospective design and small case numbers (< 50). The aim of this prospective European multicenter study is to compare both drainage procedures using ultrasound-guidance and primary metal stent implantation in patients with malignant distal bile duct obstruction (PUMa Trial). Methods The study is designed as a non-randomized, controlled, parallel group, non-inferiority trial. Each of the 16 study centers performs the procedure with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent is intended in both procedures in the first session. Primary end point is technical success. Secondary end points are clinical success, duration pf procedure, AEs graded by severity, length of hospital stay, re-intervention rate and survival within 6 months. The target case number is 212 patients (12 calculated dropouts included). Discussion This study might help to clarify whether PTBD is non-inferior to EUS-BD concerning technical success, and whether one of both interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization is not provided as both procedures are rarely used after failed endoscopic biliary drainage and study centers usually prefer one of both procedures that they can perform best. |
Note: | Reproducció del document publicat a: https://doi.org/10.1371/journal.pone.0275029 |
It is part of: | PLOS ONE, 2022, vol. 17, num. 10, p. e0275029 |
URI: | http://hdl.handle.net/2445/196686 |
Related resource: | https://doi.org/10.1371/journal.pone.0275029 |
ISSN: | 1932-6203 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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