Endosonography-guided choledochoduodenostomy using a lumen apposing metal stent vs. ERCP: Individual patient data and aggregate meta-analyses

Background and study aims: Endoscopic ultrasound-guided choledochoduodenostomy using a lumen-apposing metal stent (EUS-CDSL) has been shown in randomized controlled trials (RCTs) to be effective compared with endoscopic retrograde cholangiopancreatography (ERCP) in patients with advanced malignant distal biliary obstruction (MDBO). We aimed to further ascertain safety of EUS-CDSL with greater statistical power. Patients and methods: We undertook individual patient data (IPD) and aggregate meta-analyses following the PRISMA-IPD statement. A literature search was performed from January 2013 to November 2024 using OVID MEDLINE, EMBASE, Cochrane Library, and ISI Web of Science. Additional searches were performed for abstracts and the gray literature. RCTs comparing EUS-CDSL with ERCP were included. The primary outcome was odds of 30-day procedure related adverse events (AEs). Secondary outcomes included procedure-related 14-day severe or fatal AEs, technical success, clinical success, stent dysfunction, and procedure time. Results: A total of 2679 citations were screened with three RCTs included (519 patients). The odds ratios (ORs) for 30-day AEs between EUS-CDSL and ERCP were similar (OR 0.72, 95% confidence interval [CI] 0.44-1.16). There was also no significant difference in severe or fatal AEs (OR 0.64, 95% CI 0.22-1.83). The ORs for technical success were greater for EUS-CDSL (OR 4.22, 95% CI 2.35-7.61) with shorter procedure time (mean difference -10.50 minutes (95% CI -15.28 to -5.73). No significant differences were noted in clinical success or stent dysfunction. Conclusions: Our IPD meta-analysis demonstrates safety of EUS-CDSL as a first-line alternative to ERCP in MDBO and dilated biliary tree. In addition, EUS-CDSL is associated with higher technical success and shorter procedure time.