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

Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577873
• Other study ID #: 2018-107-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: June 2018
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ;

Related Conditions & MeSH terms

• Calculi
• Cholecystectomy
• Cholecystolithiasis
• Cholelithiasis
• Complication
• Gallbladder Stones
• Gallstones

Intervention

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.

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

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (1)

Heo J, Jung MK, Cho CM. Should prophylactic cholecystectomy be performed in patients with concomitant gallstones after endoscopic sphincterotomy for bile duct stones? Surg Endosc. 2015 Jun;29(6):1574-9. doi: 10.1007/s00464-014-3844-8. Epub 2014 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biliary events	The incidence of biliary events will be compared in the two groups.	12 months
Secondary	adverse events	Number of participants with adverse events: type, frequency and intensity of adverse events.	12 months