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

Sponsor

First People's Hospital of Hangzhou (Other)

Overall Status

Completed

CT.gov ID

NCT03577873

Collaborator

(none)

128

Enrollment

Location

Arms

Actual Duration (Months)

42.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Stones Complication Cholecystectomy	Other: gallbladder preserved Procedure: cholecystectomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: gallbladder preserved 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 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.
Experimental: cholecystectomy Patients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP.	Procedure: cholecystectomy Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted.

Arm

Intervention/Treatment

Placebo Comparator: gallbladder preserved

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

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.

Experimental: cholecystectomy

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

Procedure: cholecystectomy

Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted.

Outcome Measures

Primary Outcome Measures

biliary events [12 months]
The incidence of biliary events will be compared in the two groups.

Secondary Outcome Measures

adverse events [12 months]
Number of participants with adverse events: type, frequency and intensity of adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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