Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-01 @ 4:46 PM
Study NCT ID:
NCT02867293
Status:
COMPLETED
Last Update Posted:
2016-08-15
First Post:
2016-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'graft survival', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'patient survival', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Massive Ascites']}, 'descriptionModule': {'briefSummary': 'Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver transplant candidates with tense acsites\n\nExclusion Criteria:\n\n* severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20'}, 'identificationModule': {'nctId': 'NCT02867293', 'acronym': 'AscitesLDLT', 'briefTitle': 'Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Ascites'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preop-drainage', 'description': 'ascites drained over the pre-operative week through multiple ultrasound guided paracentesis', 'interventionNames': ['Procedure: ultrasound guided ascitic fluid drainage', 'Device: ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Op-drainage', 'description': 'ascetic fluid drained through an abdominal incision after anesthesia', 'interventionNames': ['Procedure: operative drainage of ascites through small skin incision after induction of anesthesia']}], 'interventions': [{'name': 'ultrasound guided ascitic fluid drainage', 'type': 'PROCEDURE', 'armGroupLabels': ['Preop-drainage']}, {'name': 'operative drainage of ascites through small skin incision after induction of anesthesia', 'type': 'PROCEDURE', 'armGroupLabels': ['Op-drainage']}, {'name': 'ultrasound', 'type': 'DEVICE', 'armGroupLabels': ['Preop-drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62215', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Mansurah', 'state': 'Dkahleya', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'AlRefaey Kandeel', 'investigatorAffiliation': 'Mansoura University'}}}}