Liver and Bile
Gastroenterology. 2023;165(5):1249–61.e5
Endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent versus endoscopic retrograde cholangiopancreatography in malignant distal biliary obstruction: A multicenter randomized controlled study (ELEMENT trial)
Background and aims: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. The authors compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M).
Methods: In this multicenter randomized controlled trial, they recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a non-inferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles.
Results: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (standard deviation) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (p < 0.01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% confidence interval [CI]: 81.5–95.3%) of EUS-CDS and 83.1% (95% CI: 72.7–90.1%) of ERCP-M with a risk difference of 7.3% (95% CI: -4.0–18.8%) indicating non-inferiority. Stent dysfunction occurred in 9.6% versus 9.9% of EUS-CDS and ERCP-M cases, respectively (p = 0.96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted.
Conclusions: Although not superior in stent function, endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is an efficient and safe alternative to endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M) in patients with malignant distal biliary obstruction (MDBO). These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO.