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

Primary Purpose

Gallbladder Stones, Complication, Cholecystectomy

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

gallbladder preserved

cholecystectomy

About this trial

This is an interventional prevention trial for Gallbladder Stones focused on measuring gallbladder stones, common bile duct stones, Endoscopic retrograde cholangiopancreatography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 ;

Sites / Locations

Hangzhou First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

gallbladder preserved

cholecystectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

biliary events

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

Secondary Outcome Measures

adverse events

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

Full Information

NCT ID

NCT03577873

First Posted

June 5, 2018

Last Updated

June 24, 2018

Sponsor

First People's Hospital of Hangzhou

1. Study Identification

Unique Protocol Identification Number

NCT03577873

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gallbladder Stones, Complication, Cholecystectomy

Keywords

gallbladder stones, common bile duct stones, Endoscopic retrograde cholangiopancreatography

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

gallbladder preserved

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

cholecystectomy

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

gallbladder preserved

Intervention Description

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

Procedure

Intervention Name(s)

cholecystectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

biliary events

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

adverse events

Description

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 ;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiangfeng Zhang, M.S

Organizational Affiliation

First People's Hospital of Hangzhou

Official's Role

Study Director

Facility Information:

Facility Name

Hangzhou First People's Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

31006

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25294531

Citation

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.

Results Reference

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

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