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

Zhejiang University

Status: Completed

Conditions: Cholecystectomy; Complication; Gallbladder Stones

Treatments: Other: gallbladder preserved; Procedure: cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03577873

2018-107-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 ;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups, including a placebo group

gallbladder preserved

Placebo Comparator group

Description:

Patients with stones in their bile ducts and gallbladders will keep gallbladders in stay after clearance of bile duct stones with ERCP.

Treatment:

Other: gallbladder preserved

cholecystectomy

Experimental group

Description:

Patients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP.

Treatment:

Procedure: cholecystectomy