Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-16 @ 8:52 PM
Study NCT ID:
NCT01998451
Status:
UNKNOWN
Last Update Posted:
2016-03-08
First Post:
2013-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Discovery of the Double Sphincter in Gallbladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031655', 'term': 'ursodoxicoltaurine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-06', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-24', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Discovery of The Double Sphincter in Gallbladder', 'timeFrame': 'All the patients will be follow-up for an expected average of 3 years.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['double sphincter in gallbladder', 'recurrence rate of gallstones'], 'conditions': ['Gallstone']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- people with gallbladder double sphincter\n\nExclusion Criteria:\n\n\\- people without gallbladder double sphincter'}, 'identificationModule': {'nctId': 'NCT01998451', 'briefTitle': 'The Discovery of the Double Sphincter in Gallbladder', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'The Discovery of the Double Sphincter in Gallbladder', 'orgStudyIdInfo': {'id': 'GYGDWK-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double sphincter group', 'description': 'patients from double sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.', 'interventionNames': ['Drug: Tauroursodeoxycholic acid']}, {'type': 'OTHER', 'label': 'general gallbladder sphincter group', 'description': 'patients from general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.', 'interventionNames': ['Drug: Tauroursodeoxycholic acid']}], 'interventions': [{'name': 'Tauroursodeoxycholic acid', 'type': 'DRUG', 'otherNames': ['TUCA'], 'description': 'patients from double sphincter group and general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.', 'armGroupLabels': ['Double sphincter group', 'general gallbladder sphincter group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '550001', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengyi Sun, M.D.', 'role': 'CONTACT'}], 'facility': 'The Discovery of the Double Sphincter in Gallbladder', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}], 'centralContacts': [{'name': 'Chengyi Sun, M.D.', 'role': 'CONTACT', 'email': '139724558@qq.com', 'phone': '+86 851-6771326'}], 'overallOfficials': [{'name': 'Chengyi Sun, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'The Affiliated Hospital of Guiyang Medial College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Chengyi Sun', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}