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RCT on Necessity of Cholecystectomy for Patients After Clearance of Bile Duct Stones

Not Applicable
Completed
Conditions
Cholecystectomy
Complication
Gallbladder Stones
Registration Number
NCT03577873
Lead Sponsor
First People's Hospital of Hangzhou
Brief Summary

To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.

Detailed Description

Cholecystectomy was recommended for patients with stones in their bile ducts and gallbladders in European and American countries after clearance of bile duct stones with ERCP, which reduced the incidence of biliary events. However, some researches showed that the incidence of biliary events was not reduced but increased.The purpose of this study is to discuss the necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
128
Inclusion Criteria

Obtention of a written informed consent; Clinical diagnosis of gallbladder stones and common bile duct stones; No absolute operation indications of cholecystectomy

Exclusion Criteria

Intrahepatic stones; Malignant tumor disease ;

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
biliary events12 months

The incidence of biliary events will be compared in the two groups.

Secondary Outcome Measures
NameTimeMethod
adverse events12 months

Number of participants with adverse events: type, frequency and intensity of adverse events.

Trial Locations

Locations (1)

Hangzhou First People's Hospital

🇨🇳

Hangzhou, Zhejiang, China

Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China

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