Endoscopic ultrasound‐guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study
Giuseppe Vanella,
Roberto Leone,
Francesco Frigo,
Michiel Bronswijk,
Roy L. J. vanWanrooij,
Domenico Tamburrino,
Giulia Orsi,
Giulio Belfiori,
Marina Macchini,
Michele Reni,
Luca Aldrighetti,
Massimo Falconi,
Gabriele Capurso,
Schalk van derMerwe,
Paolo Giorgio Arcidiacono
Affiliations
Giuseppe Vanella
Pancreatobiliary Endoscopy and Endosonography Division Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Roberto Leone
Pancreatobiliary Endoscopy and Endosonography Division Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Francesco Frigo
Pancreatobiliary Endoscopy and Endosonography Division Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Michiel Bronswijk
Department of Gastroenterology and Hepatology University Hospitals Gasthuisberg University of Leuven Leuven Belgium
Roy L. J. vanWanrooij
Department of Gastroenterology and Hepatology Amsterdam UMC University of Amsterdam Amsterdam Gastroenterology Endocrinology & Metabolism Amsterdam the Netherlands
Domenico Tamburrino
Pancreatic Surgery Unit Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Giulia Orsi
Medical Oncology Department Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Giulio Belfiori
Pancreatic Surgery Unit Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Marina Macchini
Medical Oncology Department Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Michele Reni
Vita‐Salute San Raffaele University Milan Italy
Luca Aldrighetti
Vita‐Salute San Raffaele University Milan Italy
Massimo Falconi
Vita‐Salute San Raffaele University Milan Italy
Gabriele Capurso
Pancreatobiliary Endoscopy and Endosonography Division Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Schalk van derMerwe
Department of Gastroenterology and Hepatology University Hospitals Gasthuisberg University of Leuven Leuven Belgium
Paolo Giorgio Arcidiacono
Pancreatobiliary Endoscopy and Endosonography Division Pancreas Translational and Clinical Research Center IRCCS San Raffaele Scientific Institute Milan Italy
Abstract Objectives Malignant double obstruction, defined as the simultaneous presence of biliary and gastric outlet obstruction, represents a challenging clinical scenario. Previous retrospective experiences have demonstrated shorter dysfunction‐free survival (DyFS) of endoscopic ultrasound‐guided choledochoduodenostomy (EUS‐CDS) versus EUS‐hepaticogastrostomy (EUS‐HGS) in this setting, but no prospective evidence is available. Methods Twenty consecutive patients with malignant double obstruction, treated with EUS‐gastroenterostomy (and EUS‐guided biliary drainage, following a previously failed ERCP, were enrolled in a prospective observational study (ClinicalTrials.gov NCT04813055) comparing EUS‐CDS versus EUS‐HGS. Efficacy and safety were evaluated, with Biliary Dysfunctions as the primary outcome and DyFS using Kaplan‐Meier estimates as a primary measure. Results Twenty patients (75% with pancreatic cancer, 50% with metastatic disease) with EUS‐gastroenterostomy were included (seven EUS‐CDS and 13 EUS‐HGS). No significant difference was detected at baseline. Technical success was 100% in both groups. EUS‐CDS compared to EUS‐HGS showed similar clinical success (100% vs. 92.3%, p = 0.5), a higher rate of post‐procedural adverse events (42.9% vs. 7.7%, p = 0.067, mostly related to severe/fatal cholangitis in the EUS‐CDS group) and a higher rate of biliary dysfunctions during follow‐up (71.4% vs. 16.7%, p = 0.002). DyFS was significantly shorter in the EUS‐CDS group (39 [15–62] vs. 268 [192–344] days, p = 0.0023), with a 30‐days DyFS probability of 57.1% vs. 100% (hazard ratio = 7.8 [1.4–44.2]). Conclusions In this prospective comparison of patients with malignant double obstruction undergoing EUS‐gastroenterostomy, treating jaundice with EUS‐CDS versus EUS‐HGS resulted in a reduced probability of survival without biliary events and an increased risk of biliary dysfunctions (number needed to harm = 1.8), with detection of severe/fatal cholangitis.
