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

Not Applicable

Completed

• Conditions: Cholecystectomy; Complication; Gallbladder Stones
• Interventions: Procedure: cholecystectomy; Other: gallbladder preserved

• 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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-24
• Last Update Submitted: 2018-06-24
• Study First Posted: 2018-07-05
• Last Update Posted: 2018-07-05

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

Arm && Interventions

Group	Intervention	Description
cholecystectomy	cholecystectomy	Patients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP.
gallbladder preserved	gallbladder preserved	Patients with stones in their bile ducts and gallbladders will keep gallbladders in stay after clearance of bile duct stones with ERCP.

Primary Outcome Measures

Name	Time	Method
biliary events	12 months	The incidence of biliary events will be compared in the two groups.

Secondary Outcome Measures

Name	Time	Method
adverse events	12 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