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临床试验/NCT02698137
NCT02698137已完成不适用

Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program

Clinical Hospital Colentina3 个研究点 分布在 3 个国家目标入组 1,843 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,843
试验地点
3
主要终点
procedure-related adverse events

研究概览

简要总结

The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications).

Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.

详细描述

This is an investigator-driven, prospective multicenter trial which analyzes the impact of trainee participation on procedure-related outcome (technical success and procedure-related complications).

All ERCPs in the participating centers will be documented using a standard report form which will require the attending endoscopist to provide data relating to the patient (age, gender, diagnosis, bilirubin levels) and the procedure (including but not limited to the indication, technical aspects including cannulation technique, time to cannulation, degree of trainee involvement - where appropriate, procedure-related adverse events and their outcome).

Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large database, stemming from the experience of several teaching centers in order to identify the main patient and operator-related factors which might influence the outcome of the procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients undergoing ERCP with attempted cannulation of either the major or minor papilla

排除标准

  • refusal to sign the informed consent

结局指标

主要结局

procedure-related adverse events

时间窗: 30 days

the percentage of patients experiencing procedure-related adverse events (i.e post-ERCP pancreatitis; postERCP cholangitis; perforation; postERCP bleeding or death) occuring within 30 days of the procedure

次要结局

  • technical failure of the procedure(30 days)

研究者

发起方
Clinical Hospital Colentina
申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Theodor Alexandru Voiosu

MD, PhD

Clinical Hospital Colentina

研究点 (3)

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