Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- Incidence of PEP
研究概览
简要总结
This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.
详细描述
In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.
排除标准
- •active cholangitis or pancreatitis
- •chronic pancreatitis,
- •previous sphincterotomy,
- •prior gastric surgery,
- •coagulopathy,
- •severe comorbidity (need for tracheal intubation)
- •patients who refused or were unable to give informed consent.
- •patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"),
- •detection of ampulloma or peri-papillary diverticula during ERCP.
结局指标
主要结局
Incidence of PEP
时间窗: 24 hours
次要结局
- Incidence of overall complications(24 hours)
研究者
Testoni Pier Alberto
Professor
Università Vita-Salute San Raffaele