EUS-Choledochoduodenostomy versus Hepaticogastrostomy combined with EUS-Gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): a prospective comparative study

Aims Combined Biliary (BO) and Gastric Outlet Obstruction (GOO) represent a challenging clinical scenario. Previous retrospective experiences have demonstrated higher risk of Dysfunction-Free survival (DFS) of EUS-guided Choledochoduodenostomy (EUS-CDS) versus EUS-Hepaticogastrostomy (EUS-HGS) in this scenario, but no prospective evidence is available.

Methods All consecutive patients treated for double obstruction between 2021-2023 were eligible for inclusion upon receiving EUS-guided Gastroenterostomy (EUS-GE) for GOO and either EUS-CDS or EUS-HGS for BO according to endoscopist preference. DFS prospective surveillance started from the day the 2 procedures coexisted. Efficacy and safety were evaluated, with biliary dysfunctions as primary outcome and DFS using Kaplan-Meier estimates (with log-rank test) as primary measure.

Results Twenty patients (75% with pancreatic cancer, 50% with metastatic disease) with EUS-GE were included (7 EUS-CDS and 13 EUS-HGS). No significant difference was detected at baseline. Technical success was 100% in both groups. EUS-CDS versus 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 (57.1% vs. 16.7%, p=0.074).

DFS was significantly shorter in the EUS-CDS group (39 [12-66] vs. 267 [192-344] days, p=0.0043), with a 30-days probability of DFS of 53.6% vs. 100%, HR=7.4 [1.1-52.3].

Conclusions In this prospective comparison of patients with malignant double obstruction undergoing EUS-GE, treating jaundice with EUS-CDS versus EUS-HGS resulted in reduced probability of survival without biliary events, with detection of severe/fatal cholangitis.

NCT04813055

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Artikel online veröffentlicht:
15. April 2024