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The Discovery of the Double Sphincter in Gallbladder

Primary Purpose

Gallstone

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Tauroursodeoxycholic acid

About this trial

This is an interventional prevention trial for Gallstone focused on measuring double sphincter in gallbladder, recurrence rate of gallstones

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- people with gallbladder double sphincter

Exclusion Criteria:

- people without gallbladder double sphincter

Sites / Locations

The Discovery of the Double Sphincter in GallbladderRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Double sphincter group

general gallbladder sphincter group

Arm Description

patients from double sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.

patients from general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.

Outcomes

Primary Outcome Measures

The Discovery of The Double Sphincter in Gallbladder

The gallbladder of some gallstone patients contain a new Anatomical structure named Double sphincter which located in the middle of gallbladder，we supposed it may be related to the formation of gallstone and pressure of bile duct.Its formation is related to genetic factors.

Secondary Outcome Measures

Full Information

NCT ID

NCT01998451

First Posted

November 13, 2013

Last Updated

March 6, 2016

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01998451

Brief Title

The Discovery of the Double Sphincter in Gallbladder

Official Title

The Discovery of the Double Sphincter in Gallbladder

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

We found a new Double sphincter which located in the neck of gallbladder，we supposed it may be related to control pressure of bile duct.Its formation is related to genetic factors.

Detailed Description

To contrast the recurrence rate of gallstones between patients with gallbladder double sphincter and patients with general gallbladder sphincter who underwent the treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation. Method:Patients with gallbladder double sphincter and patients with general gallbladder sphincter who underwent the treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation in The Affiliated Hospital of Guiyang Medical College from May 2012 to December 2015. We collect these patients' bile during surgery.Patients with gallbladder double sphincter as trial group, patients with general gallbladder sphincter as control group.the overall follow-up period is 3 years. Then the investigators statistically analyze improvement of cholecystolithiasis symptoms, thickness of gall bladder wall, the gallbladder function and the rate of the recurrence of cholesterol gallstone in 2 groups.we also analysis of the genetic differences from bile between two groups.

6. Conditions and Keywords

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

Gallstone

Keywords

double sphincter in gallbladder, recurrence rate of gallstones

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Double sphincter group

Arm Type

Experimental

Arm Description

patients from double sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.

Arm Title

general gallbladder sphincter group

Arm Type

Other

Arm Description

patients from general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.

Intervention Type

Drug

Intervention Name(s)

Tauroursodeoxycholic acid

Other Intervention Name(s)

TUCA

Intervention Description

patients from double sphincter group and general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.

Primary Outcome Measure Information:

Title

The Discovery of The Double Sphincter in Gallbladder

Description

Time Frame

All the patients will be follow-up for an expected average of 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - people with gallbladder double sphincter Exclusion Criteria: - people without gallbladder double sphincter

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chengyi Sun, M.D.

Phone

+86 851-6771326

139724558@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chengyi Sun, M.D.

Organizational Affiliation

The Affiliated Hospital of Guiyang Medial College

Official's Role

Study Chair

Facility Information:

Facility Name

The Discovery of the Double Sphincter in Gallbladder

City

Guiyang

State/Province

Guizhou

ZIP/Postal Code

550001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chengyi Sun, M.D.

12. IPD Sharing Statement

Learn more about this trial

The Discovery of the Double Sphincter in Gallbladder

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