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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial on Necessity of Cholecystectomy for Patients With Bile Duct Stones Combined With Gallbladder Stones After Clearance of Stones

Conditions
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Gallbladder Stones, Complication, Cholecystectomy

Intervention / Treatment
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* Other: gallbladder preserved
* Procedure: cholecystectomy


Participation Criteria
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Eligibility Criteria
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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 ;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: gallbladder preserved<br>Patients with stones in their bile ducts and gallbladders will keep gallbladders in stay after clearance of bile duct stones with ERCP. | Other: gallbladder preserved<br>* Gallbladders will be remained after clearance of bile duct stones with ERCP and conventional therapy, such as fluid replacement and prophylactic anti infection, will be accepted.<br>|
| Experimental: cholecystectomy<br>Patients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP. | Procedure: cholecystectomy<br>* Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biliary events | The incidence of biliary events will be compared in the two groups. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Number of participants with adverse events: type, frequency and intensity of adverse events. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic retrograde cholangiopancreatography, gallbladder stones, common bile duct stones