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NCT01998451 Clinical Trial

The Discovery of the Double Sphincter in Gallbladder

Gallstone Clinical Trial

Official title:
The Discovery of the Double Sphincter in Gallbladder

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01998451
Other study ID # GYGDWK-03
Secondary ID
Status Recruiting
Phase Phase 4
First received November 13, 2013
Last updated March 6, 2016
Start date December 2012
Est. completion date December 2018

Study information
Verified date March 2016
Source The First Affiliated Hospital of Guangzhou Medical University
Contact Chengyi Sun, M.D.
Phone +86 851-6771326
Email 139724558@qq.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 70 Years
Eligibility Inclusion Criteria:

- people with gallbladder double sphincter

Exclusion Criteria:

- people without gallbladder double sphincter

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China The Discovery of the Double Sphincter in Gallbladder Guiyang Guizhou

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. All the patients will be follow-up for an expected average of 3 years. Yes
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