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The Discovery of the Double Sphincter in Gallbladder

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ClinicalTrials.gov Identifier: NCT01998451
Recruitment Status : Unknown
Verified March 2016 by Chengyi Sun, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Chengyi Sun, 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.

Condition or disease Intervention/treatment Phase
Gallstone Drug: Tauroursodeoxycholic acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Discovery of the Double Sphincter in Gallbladder
Study Start Date : December 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

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 Name: TUCA

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 Name: TUCA




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- people with gallbladder double sphincter

Exclusion Criteria:

- people without gallbladder double sphincter


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998451


Contacts
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Contact: Chengyi Sun, M.D. +86 851-6771326 139724558@qq.com

Locations
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China, Guizhou
The Discovery of the Double Sphincter in Gallbladder Recruiting
Guiyang, Guizhou, China, 550001
Contact: Chengyi Sun, M.D.         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Study Chair: Chengyi Sun, M.D. The Affiliated Hospital of Guiyang Medial College

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Responsible Party: Chengyi Sun, professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01998451     History of Changes
Other Study ID Numbers: GYGDWK-03
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Chengyi Sun, The First Affiliated Hospital of Guangzhou Medical University:
double sphincter in gallbladder
recurrence rate of gallstones

Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Tauroursodeoxycholic acid
Taurochenodeoxycholic Acid
Antiviral Agents
Anti-Infective Agents
Cholagogues and Choleretics
Gastrointestinal Agents