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)

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...

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Detalles Bibliográficos
Autores: 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
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/196686
Acceso en línea:https://hdl.handle.net/2445/196686
Access Level:acceso abierto
Palabra clave:Assaigs clínics
Colèstasi
Endoscòpia
Conductes biliars
Clinical trials
Cholestasis
Endoscopy
Bile ducts
Descripción
Sumario: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.

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