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临床试验/NCT06130163
NCT06130163已完成不适用

Benefits and Advantages of Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis in a High Expertise Center

Kepler University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Post-ERCP Pancreatitis

研究概览

简要总结

At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) are performed in cases of simultaneous cholecysto- and choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. A standardized procedure with implemented logistics has been established. This study compares intraoperative and postoperative ERCP.

详细描述

At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) in cases of simultaneous cholecysto- and choledocholithiasis are performed. Usually an intraoperative ERCP followed by a preoperative ERCP is preferred. At the Kepler University hospital a high level of expertise in endoscopy and an interdisciplinary endoscopy team (surgical and internal medicine department) makes this high level of effort possible. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. A standardized procedure with implemented logistics has been established.

The aim of this study is to demonstrate and compare the advantages of both procedures at KUK from 1.1.2020 to 30.6.2023 (intraoperative and postoperative ERCP) in terms of morbidity, endoscopic success and the better way for patients and surgeons in clinics.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • simultaneous cholecysto-, choledocholithiasis
  • emergency or elective
  • confirmed choledocholithiasis
  • intraoperative ERCP
  • preoperative ERCP followed by cholecystectomy
  • postoperative ERCP

排除标准

  • < 18 years

结局指标

主要结局

Post-ERCP Pancreatitis

时间窗: 48 hours after intervention

radiological/blood sample/pain

次要结局

  • Re-choledocholithiasis(up to one year after first admission)
  • Surgical method(at surgery)
  • Successful ERCP(at ERCP)
  • Re-Intervenition(30 days after surgery and/or ERCP)
  • LOS(9 months after first admission)
  • Costs(until 30 days after second surgery and/or ERCP)

研究者

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

Dr. Sandra Raab

Dr. med. univ.

Kepler University Hospital

研究点 (1)

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