Z Gastroenterol 2025; 63(08): e619
DOI: 10.1055/s-0045-1811104
Abstracts | DGVS/DGAV
Kurzvorträge
Gallenwegsmanagement: Kühler Kopf in engen Röhren Freitag, 19. September 2025, 16:10 – 17:22, Seminarraum 6 + 7

Percutaneous transhepatic biliary drainage (PTBD) versus endoscopic ultrasound-guided biliary drainage (EUS-BD) with primary metal stent for unresectable malignant distal biliary obstruction (MDBO) after failed ERCP: a European prospective controlled multicenter trial (PUMa trial)

Authors

  • D Schmitz

    1   Helios Kliniken Schwerin, University Campus of Medical School Hamburg, Department of Gastroenterology and Infectiology,, Schwerin, Deutschland
    2   Theresienkrankenhaus and St. Hedwig-Klinik, Teaching Hospital of Heidelberg University, Department of Gastroenterology, Oncology and Diabetology, Mannheim, Deutschland

  • J Gornals

    3   Hospital Universitari de Bellvitge, Department of Digestive Disease, Barcelona, Spanien

  • J Vila

    4   Complejo Hospitalario de Navarra, Endoscopy Unit, Pamplona, Spanien

  • A Schmidt

    5   University Hospital Freiburg, Department of Medicine II: Gastroenterology, Hepatology, Endocrinology, and Infectious Diseases, Freiburg, Deutschland
    6   Robert-Bosch-Krankenhaus, Department of Gastroenterology, Hepatology and Endocrinology, Stuttgart, Deutschland

  • T Kleemann

    7   Carl-Thiem-Klinikum Cottbus, Department of Gastroenterology and Rheumatology, Cottbus, Deutschland

  • JR A Tomo

    8   Hospital General Universitario de Alicante, Department of Digestive Diseases, Alicante, Spanien

  • A Amanzada

    9   Universitätsmedizin Göttingen, Department of Gastroenterology, Gastrointestinal Oncology and Endocrinology, Göttingen, Deutschland

  • M Dollhopf

    10   München Klinik Neuperlach, Department of Gastroenterology and Hepatology, München, Deutschland

  • E Redondo-Cerezo

    11   Hospital universitario Virgen de las Nieves, Department of Gastrointestinal Endoscopy, Granada, Spanien

  • J Weigt

    12   Universitätsklinikum Magdeburg, Department of Gastroenterology, Hepatology and Infectiology, Magdeburg, Deutschland

  • T Voigtländer

    13   Medizinische Hochschule Hannover, Department of Gastroenterology, Hepatology and Endocrinology, Hannoveer, Deutschland

  • T von Hahn

    14   Asklepios Klinik Barmbek, Department of Gastroenterology, Hepatology, and Interventional Endoscopy, Hamburg, Deutschland

  • F Franck

    10   München Klinik Neuperlach, Department of Gastroenterology and Hepatology, München, Deutschland

  • F J García-Alonso

    15   Hospital Universitario Río Hortega, Department of Gastrointestinal Endoscopy, Valladolid, Spanien

  • M Schich

    5   University Hospital Freiburg, Department of Medicine II: Gastroenterology, Hepatology, Endocrinology, and Infectious Diseases, Freiburg, Deutschland

  • A Garcia-Sumalla

    16   Hospital Universitari de Bellvitge, Department of Digestive Diseases, Barcelona, Spanien

  • S Prax

    17   Helios Kliniken Schwerin, University Campus of Medical School Hamburg, Department of Gastroenterology and Infectiology, Schwerin, Deutschland

  • A Arrubla

    4   Complejo Hospitalario de Navarra, Endoscopy Unit, Pamplona, Spanien

  • A Küllmer

    5   University Hospital Freiburg, Department of Medicine II: Gastroenterology, Hepatology, Endocrinology, and Infectious Diseases, Freiburg, Deutschland

  • F Grassmann

    18   Medical School Hamburg, Institute for Medical Statistics and Epidemiology, Hamburg, Deutschland

  • J Rudi

    2   Theresienkrankenhaus and St. Hedwig-Klinik, Teaching Hospital of Heidelberg University, Department of Gastroenterology, Oncology and Diabetology, Mannheim, Deutschland

  • C T Valiente

    2   Theresienkrankenhaus and St. Hedwig-Klinik, Teaching Hospital of Heidelberg University, Department of Gastroenterology, Oncology and Diabetology, Mannheim, Deutschland
    17   Helios Kliniken Schwerin, University Campus of Medical School Hamburg, Department of Gastroenterology and Infectiology, Schwerin, Deutschland

  • M Perez-Miranda

    15   Hospital Universitario Río Hortega, Department of Gastrointestinal Endoscopy, Valladolid, Spanien
Further Information
Also available at
 
 

    Background: Despite the increasing use of EUS-BD, the inferiority of PTBD versus EUS-BD in patients with unresectable MDBO after failed ERCP has not been demonstrated in a prospective, multicenter, international study.

    Methods: In 14 centers in Spain and Germany, patients were assigned to the center with the highest competence for PTBD or EUS-BD. Primary metal stenting was planned in both groups. The primary endpoint was technical success. The study was designed as a non-inferiority trial with a 6-month follow-up period and propensity score matching.

    Results: A total of 209 patients (mean age 73 years) were included in the study between 12/2018 and 8/2024. PTBD was technically successful in 62/68 (91.2%) and EUS-BD in 138/141 (97.9%) of patients (p=0.06), including 58 hepatogastrostomies, 58 choledochoduodenostomies, 17 anterograde stents and 5 rendezvous procedures with ERCP. Pancreatic and gastric cancer were the leading causes of MDBO (77%) and gastric outlet obstruction was the leading cause of failed ERCP (49%). Clinical success (≥50% bilirubin reduction/7d), pain score, rate of adverse events (grade 1-4), length of hospital stay and overall survival were not significantly different, except for procedure time (43.7 vs. 58.1 minutes) and rate of biliary re-interventions per patient within 30 days (0.04 vs. 0.31/patient) in favor of EUS-BD.

    Conclusions: Despite a trend in favor of EUS-BD, PTBD with primary metal stenting was not inferior for unresectable MDBO except for procedure time and rate of biliary re-interventions. Depending on the expertise of the center, both procedures may still be a possible treatment option after failed ERCP. (ClinicalTrials.gov number NCT03546049).


     

    Publication History

    Article published online:
    04 September 2025

    © 2025. Thieme. All rights reserved.

    Georg Thieme Verlag KG
    Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany