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)

D Schmitz; J Gornals; J Vila; A Schmidt; T Kleemann; JR A Tomo; A Amanzada; M Dollhopf; E Redondo-Cerezo; J Weigt; T Voigtländer; T von Hahn; F Franck; F J García-Alonso; M Schich; A Garcia-Sumalla; S Prax; A Arrubla; A Küllmer; F Grassmann; J Rudi; C T Valiente; M Perez-Miranda

doi:10.1055/s-0045-1811104

Zeitschrift für Gastroenterologie, Inhaltsverzeichnis

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

¹Helios Kliniken Schwerin, University Campus of Medical School Hamburg, Department of Gastroenterology and Infectiology,, Schwerin, Deutschland

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

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

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

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

⁶Robert-Bosch-Krankenhaus, Department of Gastroenterology, Hepatology and Endocrinology, Stuttgart, Deutschland
T Kleemann

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

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

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

¹⁰München Klinik Neuperlach, Department of Gastroenterology and Hepatology, München, Deutschland
E Redondo-Cerezo

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

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

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

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

¹⁰München Klinik Neuperlach, Department of Gastroenterology and Hepatology, München, Deutschland
F J García-Alonso

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

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

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

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

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

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

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

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

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

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

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

Abstract

Volltext

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).