RT Journal Article
T1 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).
A1 Schmitz, Daniel
A1 Valiente, Carlos T
A1 Dollhopf, Markus
A1 Perez-Miranda, Manuel
A1 Küllmer, Armin
A1 Gornals, Joan
A1 Vila, Juan
A1 Weigt, Jochen
A1 Voigtländer, Torsten
A1 Redondo-Cerezo, Eduardo
A1 von Hahn, Thomas
A1 Albert, Jörg
A1 Vom Dahl, Stephan
A1 Beyna, Torsten
A1 Hartmann, Dirk
A1 Franck, Franziska
A1 García-Alonso, Francisco Javier
A1 Schmidt, Arthur
A1 Garcia-Sumalla, Albert
A1 Arrubla, Amaia
A1 Joerdens, Markus
A1 Kleemann, Tobias
A1 Tomo, José Ramón Aparicio
A1 Grassmann, Felix
A1 Rudi, Jochen
AB 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 ( 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). 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. ClinicalTrials.gov ID: NCT03546049 (22.05.2018).
YR 2022
FD 2022-10-27
LK http://hdl.handle.net/10668/20435
UL http://hdl.handle.net/10668/20435
LA en
DS RISalud
RD Apr 8, 2025