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)

Daniel Schmitz, Carlos T Valiente, Markus Dollhopf, Manuel Perez-Miranda, Armin Küllmer, Joan Gornals, Juan Vila, Jochen Weigt, Torsten Voigtländer, Eduardo Redondo-Cerezo, Thomas von Hahn, Jörg Albert, Stephan Vom Dahl, Torsten Beyna, Dirk Hartmann, Franziska Franck, Francisco Javier García-Alonso, Arthur Schmidt, Albert Garcia-Sumalla, Amaia Arrubla, Markus Joerdens, Tobias Kleemann, José Ramón Aparicio Tomo, Felix Grassmann, Jochen Rudi, Daniel Schmitz, Carlos T Valiente, Markus Dollhopf, Manuel Perez-Miranda, Armin Küllmer, Joan Gornals, Juan Vila, Jochen Weigt, Torsten Voigtländer, Eduardo Redondo-Cerezo, Thomas von Hahn, Jörg Albert, Stephan Vom Dahl, Torsten Beyna, Dirk Hartmann, Franziska Franck, Francisco Javier García-Alonso, Arthur Schmidt, Albert Garcia-Sumalla, Amaia Arrubla, Markus Joerdens, Tobias Kleemann, José Ramón Aparicio Tomo, Felix Grassmann, Jochen Rudi

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.

Trial registration: ClinicalTrials.gov ID: NCT03546049 (22.05.2018).

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. SPIRIT schedule.
Fig 1. SPIRIT schedule.
* List specific timepoints in this row: -t1 = one day before intervention, t1 = day after intervention, t2 = one day after intervention, t3 = 7 days after intervention, t4 = 6 months after intervention.
Fig 2. Illustration of the four biliary…
Fig 2. Illustration of the four biliary drainage procedures in the PUMa trial.
1A: PTBD with ultrasound-guided bile duct access, 1B: EUS-guided choledochoduodenostomy (EUS-CDS), 1C: EUS-guided hepaticogastrostomy (EUS-HGS), 1D: EUS-guided antegrade stenting (EUS-AGS).
Fig 3. Algorithm for the selected EUS-BD…
Fig 3. Algorithm for the selected EUS-BD procedure in distal, malignant bile duct obstruction.

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