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Completed

NCT Number: NCT03577873

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

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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Key information

Conditions

Gallbladder Stones Biliary Tract Diseases Cholecystectomy Cholecystolithiasis Cholelithiasis Complication Digestive System Diseases Gallbladder Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ;

Treatment and study plan

gallbladder preserved

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

Procedure

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

Primary outcomes

  1. biliary events

    Time frame: 12 months

    The incidence of biliary events will be compared in the two groups.

Secondary outcomes

  1. adverse events

    Time frame: 12 months

    Number of participants with adverse events: type, frequency and intensity of adverse events.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2018
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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