Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-03-31 @ 10:45 AM
Study NCT ID:
NCT01907750
Status:
UNKNOWN
Last Update Posted:
2016-03-01
First Post:
2013-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001658', 'term': 'Biliary Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-28', 'studyFirstSubmitDate': '2013-06-23', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early postoperative biliary fistula', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'biliary stricture', 'timeFrame': '2 years postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['biliary fistula', 'biliary stricture', 'biliary drainage tube'], 'conditions': ['Living Donor Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.', 'detailedDescription': "a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining).\n\nA 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases.\n\nthe study is to compare the effectiveness and safety of 2 different placement techniques:\n\n1. the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct\n2. a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living donor liver transplantation\n* single bile duct in the graft\n\nExclusion Criteria:\n\n* multiple bile ducts'}, 'identificationModule': {'nctId': 'NCT01907750', 'briefTitle': 'Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': 'Biliary_TCvsTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transanastomotic tube', 'description': 'use of transanastomotic tube.', 'interventionNames': ['Device: biliary drainage tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transcystic tube', 'description': 'use of transcystic tube to drain bile duct', 'interventionNames': ['Device: biliary drainage tube']}], 'interventions': [{'name': 'biliary drainage tube', 'type': 'DEVICE', 'armGroupLabels': ['Transanastomotic tube', 'Transcystic tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Al-Dakahleia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmad M Sultan, MD', 'role': 'CONTACT', 'email': 'dr_ahmadsultan@hotmail.com', 'phone': '+201003886838'}, {'name': 'Ahmad M Sultan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gastro-enterolgy surgical center, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Ahmad M Sultan', 'role': 'CONTACT', 'email': 'dr_ahmadsultan@hotmail.com', 'phone': '+201003886838'}, {'name': 'Tarek Salah', 'role': 'CONTACT', 'email': 'Tarksal@yahoo.com'}], 'overallOfficials': [{'name': 'Ahmad M Sultan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastro-enterology surgical center, Mansoura University'}, {'name': 'Mohammed Abdul-Wahab, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gastro-enterolgy surgical center, Mansoura University'}, {'name': 'Tarek Salah, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gastro-enterolgy surgical center, Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmad Mohammad Ahmad Sultan', 'investigatorAffiliation': 'Mansoura University'}}}}