EUS-guided choledochoduodenostomy using a lumen apposing metal stent vs. ERCP in malignant distal biliary obstruction: an individual patient data meta-analysis of randomized controlled trials

Aims EUS-guided choledochoduodenostomy (EUS-CDS) using a lumen apposing metal stent (LAMS) has been shown in RCTs to be effective in malignant distal biliary obstruction. Its safety when compared to endoscopic retrograde cholangiopancreatography (ERCP), however, has not been adequately assessed due to the limited sample size. This meta-analysis aims to ascertain the safety of EUS-CDS compared to ERCP. We hypothesize that EUS-CDS has comparable safety and clinical success as ERCP while have superior technical success.

Methods This is a meta-analysis of RCTs using individual patient data (IPD) following the PRISMA-IPD statement. This study was registered in Prospero prior to analysis (481542). A comprehensive literature search was performed from Jan 2013 to Nov 2024 using OVID MEDLINE, EMBASE, Cochrane Library, and ISI Web of Science with MeSH and controlled vocabulary for terms specified for 1) endoscopic ultrasound guided biliary drainage, 2) endoscopic ultrasound guided choledochoduodenostomy, 3) endosonography guided biliary drainage, 4) endosonography guided choledochoduodenostomy. We additionally searched abstracts and the gray literature. RCTs comparing EUS-CDS with LAMS vs. ERCP in malignant distal biliary obstruction were included. Studies using other types of stents, retrospective studies, non-randomized prospective studies, and sole abstracts were excluded. The primary endpoint was the rate of procedure related severe or fatal adverse events as defined by the ASGE lexicon within 14 days. Secondary endpoints include overall 30-day adverse events (AE), stent dysfunction, technical success, clinical success, and procedure time. Deanonymized dataset of published RCTs were obtained following ethics approval. Data were interpreted using a homogenized definition for each endpoint. A one-stage approach was used for all analyses Logistic mixed effects model was used to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI).

Results A total of 2679 citations were screened with three RCTs included involving a total of 519 patients (263 EUS-CDS and 256 ERCP). There was no significant difference in the odds of<14 days severe or fatal AEs between EUS-CDS and ERCP (OR 0.64, 95% CI 0.22-1.83). The odds of technical success were higher with EUS-CDS (OR 4.22 (95%CI 2.35; 7.60)) and faster with a mean difference in procedure time of SMD=-10.50(95% CI-15.28, -5.73) when compared to ERCP. Lastly, no significant differences were noted in the odds of 30-day AEs (OR 0.72, 95% CI 0.44-1.16), stent dysfunction (OR 0.78, 95% CI 0.42-1.49), or clinical success (OR 1.03, 95% CI 0.64-1.65).

Conclusions Our IPD meta-analysis provides high-quality evidence supporting the adoption of EUS-CDS as a safe, more efficient, and technically superior first-line alternative to ERCP in malignant distal biliary obstruction. Cost-effectiveness data are needed to optimally inform clinical implementation of EUS-CDS

Publication History

Article published online:
27 March 2025