在良性胆道疾病和胆道插管困难的患者中，将内镜超声引导会师技术与预切括约肌切开术作为挽救技术：一项随机对照试验。

IF 19.6 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

Annals of Internal Medicine Pub Date : 2024-10-01 Epub Date: 2024-08-27 DOI:10.7326/M24-0092

Arup Choudhury, Jayanta Samanta, Gaurav Muktesh, Jahnvi Dhar, Antriksh Kumar, Jimil Shah, Marco Spadaccini, Pankaj Gupta, Alessandro Fugazza, Vikas Gupta, Thakur Deen Yadav, Rakesh Kochhar, Cesare Hassan, Alessandro Repici, Antonio Facciorusso

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引用次数: 0

摘要

背景：用于困难胆管插管的标准抢救技术是预切括约肌切开术，而内镜超声引导会合技术（EUS-RV）是一种相对较新的方法。这两种技术作为良性胆道疾病和胆管插管困难患者胆道通路的挽救方法，目前还缺乏前瞻性的比较数据：比较 EUS-RV 和预切括约肌切开术作为良性胆道梗阻胆管插管困难时的挽救技术：设计：参与者掩蔽、平行组、优越性随机对照试验。(印度临床试验注册中心：CTRI/2020/07/026613）：2020年7月至2021年5月，三级医疗学术机构：所有良性胆道疾病和胆管插管困难且需要挽救策略的患者：患者通过计算机生成的随机区组序列以 1:1 的方式随机分配到 EUS-RV 或预切开括约肌切开术。EUS-RV 失败的患者被交叉分配到预切括约肌切开术，反之亦然：主要结果指标为技术成功率。其他结果指标包括手术时间、辐射剂量和不良事件：共有 100 名患者被随机分配到 EUS-RV（50 人）和括约肌切开术（50 人）。两组的技术成功率（92% 对 90%；P = 1.00；相对风险为 1.02 [95% CI，0.90 至 1.16]）、中位手术时间（10.1 分钟对 9.75 分钟）和总体并发症发生率（12% 对 10%；相对风险为 1.20 [CI，0.39 至 3.68]）相似。EUS-RV 组和预切开括约肌组分别有 5 名患者（10%）在内镜逆行胰胆管造影术后出现胰腺炎。所有抢救组的失败病例在转入另一组时都能成功插管：局限性：由专家进行的单中心研究：结论：内镜超声引导下会合技术和预切括约肌切开术作为良性胆道疾病胆管困难插管技术中的挽救技术，成功率相似，并发症发生率可接受：无。

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Endoscopic Ultrasound-Guided Rendezvous Technique Versus Precut Sphincterotomy as Salvage Technique in Patients With Benign Biliary Disease and Difficult Biliary Cannulation : A Randomized Controlled Trial.

Background: The standard salvage technique used for difficult bile duct cannulation is precut sphincterotomy, whereas endoscopic ultrasound-guided rendezvous technique (EUS-RV) is a relatively newer method. Prospective comparative data between these 2 techniques as salvage for biliary access in patients with benign biliary disease and difficult bile duct cannulation is lacking.

Objective: To compare EUS-RV and precut sphincterotomy as salvage technique for difficult bile duct cannulation in benign biliary obstruction.

Design: Participant-masked, parallel-group, superiority, randomized controlled trial. (Clinical Trials Registry of India: CTRI/2020/07/026613).

Setting: Tertiary care academic institute from July 2020 to May 2021.

Participants: All patients with benign biliary disease and difficult bile duct cannulation requiring salvage strategy.

Intervention: Patients were randomly assigned by computer-generated randomized blocks sequence in 1:1 fashion to either EUS-RV or precut sphincterotomy. Patients with failure in EUS-RV were crossed over to precut sphincterotomy and vice versa.

Measurements: The primary outcome measure was technical success. The other outcome measures included procedure time, radiation dose, and adverse events.

Results: In total, 100 patients were randomly assigned to EUS-RV (n = 50) and precut sphincterotomy (n = 50). The technical success rate (92% vs. 90%; P = 1.00; relative risk, 1.02 [95% CI, 0.90 to 1.16]), median procedure time (10.1 vs. 9.75 minutes), and overall complication rate (12% vs. 10%; relative risk, 1.20 [CI, 0.39 to 3.68]) were similar between the 2 groups. Five patients (10%) in the EUS-RV group and 5 patients (10%) in the precut sphincterotomy group had developed post-endoscopic retrograde cholangiopancreatography pancreatitis. All failed cases in either salvage group could be successfully cannulated when crossed over to the other group.

Limitation: Single center study done by experts.

Conclusion: Endoscopic ultrasound-guided rendezvous technique and precut sphincterotomy have similar success rates as salvage techniques in the technically challenging cohort of difficult bile duct cannulation for benign biliary disease, with acceptable complications rates.

Primary funding source: None.

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来源期刊

Annals of Internal Medicine 医学-医学：内科

CiteScore

23.90

自引率

1.80%

发文量

1136

审稿时长

3-8 weeks

期刊介绍： Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.