Liver and Bile

Gastroenterology. 2023;165(5):1249–61.e5

Chen YI, Sahai A, Donatelli G, Lam E, Forbes N, Mosko J, Paquin SC, Donnellan F, Chatterjee A, Telford J, Miller C, Desilets E, Sandha G, Kenshil S, Mohamed R, May G, Gan I, Barkun J, Calo N, Nawawi A, Friedman G, Cohen A, Maniere T, Chaudhury P, Metrakos P, Zogopoulos G, Bessissow A, Khalil JA, Baffis V, Waschke K, Parent J, Soulellis C, Khashab M, Kunda R, Geraci O, Martel M, Schwartzman K, Fiore JF, Jr., Rahme E, Barkun A

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.

DOI: 10.1053/j.gastro.2023.07.024