The Discovery of the Double Sphincter in Gallbladder

March 6, 2016 updated by: Chengyi Sun, The First Affiliated Hospital of Guangzhou Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • Recruiting
        • The Discovery of the Double Sphincter in Gallbladder
        • Contact:
          • Chengyi Sun, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- people with gallbladder double sphincter

Exclusion Criteria:

- people without gallbladder double sphincter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double sphincter group
patients from double sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.
Drug: Tauroursodeoxycholic acid
patients from double sphincter group and general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.
Other Names:
  • TUCA
Other: general gallbladder sphincter group
patients from general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.
Drug: Tauroursodeoxycholic acid
patients from double sphincter group and general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.
Other Names:
  • TUCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Discovery of The Double Sphincter in Gallbladder
Time Frame: All the patients will be follow-up for an expected average of 3 years.
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.
All the patients will be follow-up for an expected average of 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Chair: Chengyi Sun, M.D., The Affiliated Hospital of Guiyang Medial College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 24, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 6, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYGDWK-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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