Chen Yen-I, Sahai Anand, Donatelli Gianfranco, Lam Eric, Forbes Nauzer, Mosko Jeffrey, Paquin Sarto C, Donnellan Fergal, Chatterjee Avijit, Telford Jennifer, Miller Corey, Desilets Etienne, Sandha Gurpal, Kenshil Sana, Mohamed Rachid, May Gary, Gan Ian, Barkun Jeffrey, Calo Natalia, Nawawi Abrar, Friedman Gad, Cohen Albert, Maniere Thibaut, Chaudhury Prosanto, Metrakos Peter, Zogopoulos George, Bessissow Ali, Khalil Jad Abou, Baffis Vicky, Waschke Kevin, Parent Josee, Soulellis Constantine, Khashab Mouen, Kunda Rastislav, Geraci Olivia, Martel Myriam, Schwartzman Kevin, Fiore Julio F, Rahme Elham, Barkun Alan
Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
Service de Gastroentérologie, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6.
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).
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.
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.
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.
gov, Number: NCT03870386.
内镜超声引导下带膜金属支架胆管十二指肠吻合术（EUS-CDS）是一种治疗恶性远端胆管梗阻（MDBO）的有前景的方法，具有使支架通畅性更好的潜力。我们将其结果与内镜逆行胰胆管造影术联合金属支架置入术（ERCP-M）进行了比较。
在这项多中心随机对照试验中，我们在加拿大的10家机构和法国的1家机构招募了因交界可切除、局部晚期或不可切除的壶腹周围癌继发MDBO的患者。这是一项具有技术成功非劣效性评估的优效性试验。患者被随机分为EUS-CDS组或ERCP-M组。主要终点是1年时支架功能障碍的发生率，同时考虑死亡、临床失败和手术切除等竞争风险。分析按照意向性分析原则进行。
2019年2月至2022年2月，共招募了144例患者；73例被随机分配至EUS-CDS组，71例被随机分配至ERCP-M组。EUS-CDS组的平均（标准差）操作时间为14.0（11.4）分钟，ERCP-M组为23.1（15.6）分钟（P <.01）；前者40%的操作无需透视。EUS-CDS组的技术成功率为90.4%（95%CI，81.5%至95.3%），ERCP-M组为83.1%（95%CI，72.7%至90.1%），风险差异为7.3%（95%CI，-4.0%至18.8%），表明非劣效。EUS-CDS组和ERCP-M组的支架功能障碍发生率分别为9.6%和9.9%（P =.96）。在不良事件、胰十二指肠切除术和肿瘤学结局或生活质量方面未发现差异。
尽管在支架功能方面不占优势，但EUS-CDS在MDBO患者中是一种有效且安全的替代ERCP-M的方法。这些发现为EUS-CDS在临床实践中作为MDBO患者ERCP的补充和可互换的一线治疗方法得到更广泛应用提供了证据。
美国国立医学图书馆临床试验注册中心，编号：NCT03870386 。
