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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03577873

Enrollment

128

Registered

2018-07-05

Start date

2017-11-01

Completion date

2018-02-01

Last updated

2018-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy, Complication, Gallbladder Stones

Keywords

gallbladder stones, common bile duct stones, Endoscopic retrograde cholangiopancreatography

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.

Interventions

OTHERgallbladder 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.

PROCEDUREcholecystectomy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 ;

Design outcomes

Primary

Measure	Time frame	Description
biliary events	12 months	The incidence of biliary events will be compared in the two groups.

Secondary

Measure	Time frame	Description
adverse events	12 months	Number of participants with adverse events: type, frequency and intensity of adverse events.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026