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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).
- Source :
-
Gastroenterology [Gastroenterology] 2023 Nov; Vol. 165 (5), pp. 1249-1261.e5. Date of Electronic Publication: 2023 Aug 06. - Publication Year :
- 2023
-
Abstract
- 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).<br />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.<br />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.<br />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.<br />Clinicaltrials: gov, Number: NCT03870386.<br /> (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Aged, 80 and over
Female
Humans
Male
Middle Aged
Choledochostomy methods
Choledochostomy adverse effects
Choledochostomy instrumentation
Metals
Treatment Outcome
Ultrasonography, Interventional adverse effects
Cholangiopancreatography, Endoscopic Retrograde adverse effects
Cholangiopancreatography, Endoscopic Retrograde instrumentation
Cholestasis etiology
Cholestasis surgery
Cholestasis diagnostic imaging
Cholestasis therapy
Drainage instrumentation
Drainage adverse effects
Drainage methods
Endosonography
Stents
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0012
- Volume :
- 165
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 37549753
- Full Text :
- https://doi.org/10.1053/j.gastro.2023.07.024