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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-02-01

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.

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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.

Conditions

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Gallbladder Stones Complication Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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gallbladder preserved

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

Group Type PLACEBO_COMPARATOR

gallbladder preserved

Intervention Type OTHER

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.

cholecystectomy

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

Group Type EXPERIMENTAL

cholecystectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type OTHER

cholecystectomy

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

Intervention Type PROCEDURE

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