Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial)

Chen, Y. -I.; Sahai, A.; Donatelli, G.; Lam, E.; Forbes, N.; Mosko, J.; Paquin, S. C.; 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, J. A.; Baffis, V.; Waschke, K.; Parent, J.; Soulellis, C.; Khashab, M.; Kunda, R.; Geraci, O.; Martel, M.; Schwartzman, K.; Fiore, J. F.; Rahme, E.; Barkun, A.

doi:10.1053/j.gastro.2023.07.024

Background & 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. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). Methods: In this multicenter randomized controlled trial, we 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 noninferiority 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 (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. Conclusions: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with 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. Clinicaltrials: gov, Number: NCT03870386.

Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial) / Chen, Y.-I., Sahai, A., Donatelli, G., Lam, E., Forbes, N., Mosko, J., Paquin, S.C., 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., et al.. - In: GASTROENTEROLOGY. - ISSN 1528-0012. - 165:5(2023), pp. 1249-1261. [10.1053/j.gastro.2023.07.024]