The Discovery of the Double Sphincter in Gallbladder

Phase 4

• Conditions: Gallstone
• Interventions: Drug: Tauroursodeoxycholic acid

• Registration Number: NCT01998451
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-24
• Study First Posted: 2013-11-28
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-06
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• people with gallbladder double sphincter

Exclusion Criteria

• people without gallbladder double sphincter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double sphincter group	Tauroursodeoxycholic acid	patients from double sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.
general gallbladder sphincter group	Tauroursodeoxycholic acid	patients from general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.

Primary Outcome Measures

Name	Time	Method
The Discovery of The Double Sphincter in Gallbladder	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.

Trial Locations

Locations (1)

The Discovery of the Double Sphincter in Gallbladder; 🇨🇳 Guiyang, Guizhou, China