Efficacy of ERCP Using ESGE Algorithm for Biliary Cannulation: a Multicenter Prospective Italian Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Success of ERCP biliary cannulation rate
研究概览
简要总结
Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.
The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis.
详细描述
Multicenter prospective observational study, which was promoted by SIED (the Italian Society of Digestive Endoscopy) involving Italian Centers that perform ERCP.
The study was approved from the Ethics Committee in 2020 with an expected enrollment of 800 patients over three years, with the potential to enroll patients for an extended period of time.
Each Center have to enroll a minimum of 15 consecutive patients, depending on the number of enrolling centers.
Each patient need to undergo ERCP by using the different cannulation techniques reported in the ESGE algorithm, which are numbered from 1 (easy cannulation) to 9 (difficult cannulation).
Digital data entry (RedCap application) are divided in three part: 1. before ERCP (patient demographics, indications for ERCP, the degree of anesthetic risk (ASA 1-3), any prophylactic therapy for pancreatitis, any assumption/interruption of anti-platelet and/or anti-coagulant drugs, the type of sedation); 2. ERCP (cannulation details according to ESGE algorithm, difficulty and duration of the procedure, final diagnosis, expertise of the endoscopist); 3. After ERCP (early and at 30-days complications, defined and graded according to the Cotton classification).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Success of ERCP biliary cannulation rate
时间窗: At the end of the procedure.
Success obtained with the different cannulation techniques according with the ESGE algorithm
次要结局
- ERCP complication rates(At 0-72 hours, and at 30-days after the procedure.)
研究者
Alberto Mariani
Principal Investigator
IRCCS San Raffaele