NCT01998451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

6 years

First QC Date

November 13, 2013

Last Update Submit

March 6, 2016

Conditions

Gallstone

Keywords

double sphincter in gallbladderrecurrence rate of gallstones

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Double sphincter group

EXPERIMENTAL

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

Drug: Tauroursodeoxycholic acid

general gallbladder sphincter group

OTHER

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

Drug: Tauroursodeoxycholic acid

Interventions

Tauroursodeoxycholic acidDRUG

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

Also known as: TUCA
Double sphincter groupgeneral gallbladder sphincter group

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- people with gallbladder double sphincter

You may not qualify if:

  • \- people without gallbladder double sphincter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Discovery of the Double Sphincter in Gallbladder

Guiyang, Guizhou, 550001, China

RECRUITING

MeSH Terms

Conditions

Gallstones

Interventions

ursodoxicoltaurine

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Chengyi Sun, M.D.

    The Affiliated Hospital of Guiyang Medial College

    STUDY CHAIR

Central Study Contacts

Chengyi Sun, M.D.

CONTACT

+86 851-6771326139724558@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 28, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

CN(1)