Aims
In patients with distal malignant biliary obstruction (MBO) and failed endoscopic retrograde cholangiopancreatography, the American Society for Gastrointestinal Endoscopy and European Society of Gastrointestinal Endoscopy recommend endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) EUS-guided hepaticogastrostomy.1, 2 Retrospective studies report technical and clinical success rates as high as 96% for EUS-CDS by transduodenal placement of a lumen-apposing metal stent (LAMS) into an extrahepatic bile duct.3 Placement of double pigtail plastic stents (DPPS) has been described to reduce LAMS dysfunction. We conducted a meta-analysis of the efficacy and safety of EUS-CDS using a LAMS without or with DPPS to reduce stent dysfunction in the treatment of MBO.
Methods
An expert librarian conducted searches of Embase and the MEDLINE full file (via Ovid) to identify studies published in English between January 1, 2011, and January 1, 2025. Clinical studies of EUS-CDS using the AXIOS™ LAMS (Boston Scientific Corporation, Marlborough, Massachusetts, USA) including more than 10 patients were eligible. Efficacy and safety outcomes were assessed using a random-effects meta-analysis to estimate the proportion of patients with the outcome. Efficacy outcomes were technical success, clinical success, and reinterventions. The safety outcome was the proportion of patients with ≥1 serious adverse event (SAE).
Results
Eighteen eligible studies (96.7% retrospective, 54.5% male patients with mean or median age ≥ 68 years if reported) were conducted at 89 centers in 12 countries (US 1, APAC 3, Europe 8). Analyses included “cold” or “hot” (electrocautery-enhanced) LAMS without (15 studies, N=905 patients) or with (4 studies, N=141) concomitant placement of DPPS at the initial procedure. The estimated pooled proportions of patients with technical success and clinical success of EUS-CDS using the LAMS were 97.4% (95% CI 95.1–99.0%) and 94.2% (95% CI 91.4%‒96.5%), respectively. Reinterventions were performed in 11.3% (95% CI 7.0%‒16.4%) of patients. The estimated pooled proportion of patients with ≥1 SAE during the study period was 12.6% (95% CI 8.0%‒18.0%). Estimates were similar for EUS-CDS using LAMS with DPPS, including 96.4% (95% CI 88.0–99.9%) clinical success, 98.6% (95% CI 94.1%‒100%) technical success, 13.7% (8.0%–20.5%) reinterventions, 15.7% (9.5%–23.2%) patients with ≥1 SAE.
Conclusions
EUS-CDS using a LAMS without or with DPPS had similarly high technical and clinical success and comparable safety to treat MBO in adults.