跳至主要内容
临床试验/NCT07640204
NCT07640204尚未招募不适用

Complication Rates Associated With Access or Not to Endoscopic Retrograde Cholangiopancreatography (ERCP) in Units Performing Cholecystectomy, When Common Bile Duct Stones Are Detected on Intraoperative Cholangiography

Karolinska Institutet0 个研究点目标入组 10,000 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
10,000

研究概览

简要总结

The aim of this retrospective, register-based study is to investigate whether access, or no access, to endoscopic retrograde cholangiopancreatography (ERCP) at a surgical unit is associated with the risk of complications in patients undergoing laparoscopic cholecystectomy with common bile duct stones detected on intraoperative cholangiography.

详细描述

Annually, approximately 15,000 cholecystectomies are performed in Sweden. Cholecystectomy is indicated if gallstones cause recurrent biliary colic or complications. Gallstones can pass from the gallbladder into the common bile duct. Common bile duct stones (CBDS) can potentially cause biliary obstruction, cholangitis and pancreatitis.

Intraoperative cholangiography (IOC) during cholecystectomy is performed as a standard in Swedish surgical units. The arguments for routine IOC are several; routine IOC is associated with reduced risk of bile duct injury in patients with previous or ongoing cholecystitis, early detection of bile duct injury has been suggested to improve survival, and CBDS found by IOC, even small ones <4 mm, are associated with increased risk of complications and need for unplanned endoscopic retrograde cholangiopancreatography (ERCP) if no effort is made to clear the common bile duct.

American guidelines suggest performing IOC as a routine in adult patients undergoing laparoscopic cholecystectomy. Many countries do not practice routine IOC because it prolongs cholecystectomy and the evidence supporting its use is considered insufficient. European guidelines do not include routine IOC as a recommendation. On the other hand, both American and European guidelines advocate treatment of all CBDS, symptomatic or not.

CBDS represent a well-recognized clinical dilemma, especially when encountered first on IOC during cholecystectomy. In those situations, intraoperative treatment of CBDS has not been planned in advance.

There are several different approaches to remove CBDS. Worldwide, the two most common methods used are preoperative endoscopic retrograde cholangiopancreatography (ERCP) followed by cholecystectomy, or laparoscopic exploration of the common bile duct during cholecystectomy. In Sweden, the predominant treatment strategy for CBDS encountered on IOC is intraoperative ERCP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • ≥18 years old
  • Laparoscopic cholecystectomy with common bile duct stones (CBDS) detected on intraoperative cholangiography (IOC)
  • Procedure registered in the Swedish Registry for Gallstone Surgery and ERCP (GallRiks) 2015-2025

排除标准

  • Open surgery
  • Conversion to open surgery
  • Transgastric ERCP

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camilla Runfors

Principal Investigator. MD, PhD

Karolinska Institutet

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