Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-01-01 @ 12:21 AM
Study NCT ID:
NCT04988100
Status:
UNKNOWN
Last Update Posted:
2021-08-17
First Post:
2021-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-14', 'studyFirstSubmitDate': '2021-07-25', 'studyFirstSubmitQcDate': '2021-07-25', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of early graft dysfunction', 'timeFrame': 'first postoperative month', 'description': 'Number of patients who develop early graft dysfunction in each group'}, {'measure': 'Time to normalisation of ascites output', 'timeFrame': 'first postoperative month', 'description': 'time to normalisation of ascites output (in days)'}, {'measure': 'Time to normalisation of INR', 'timeFrame': 'first postoperative month', 'description': 'time to normalisation of INR (in days)'}, {'measure': 'Time to normalisation of bilirubin', 'timeFrame': 'first postoperative month', 'description': 'time to normalisation of bilirubin (in days)'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'first postoperative month', 'description': 'Morbidity as per Clavein Dindo classification'}, {'measure': 'ICU stay', 'timeFrame': 'first postoperative month', 'description': 'Duration of ICU stay (in days)'}, {'measure': 'Mortality', 'timeFrame': 'first postoperative month', 'description': 'death'}, {'measure': 'Total hospital stay', 'timeFrame': 'first postoperative month', 'description': 'duration of total stay in hospital after liver transplantation (in days)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Living Donor Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '26005570', 'type': 'BACKGROUND', 'citation': 'Gad EH, Alsebaey A, Lotfy M, Eltabbakh M, Sherif AA. Complications and mortality after adult to adult living donor liver transplantation: A retrospective cohort study. Ann Med Surg (Lond). 2015 Apr 25;4(2):162-71. doi: 10.1016/j.amsu.2015.04.021. eCollection 2015 Jun.'}, {'pmid': '25593949', 'type': 'BACKGROUND', 'citation': 'Abdeldayem H, Kashkoush S, Hegab BS, Aziz A, Shoreem H, Saleh S. Analysis of donor motivations in living donor liver transplantation. Front Surg. 2014 Jul 8;1:25. doi: 10.3389/fsurg.2014.00025. eCollection 2014.'}, {'pmid': '18791439', 'type': 'BACKGROUND', 'citation': 'Umeda Y, Yagi T, Sadamori H, Matsukawa H, Matsuda H, Shinoura S, Mizuno K, Yoshida R, Iwamoto T, Satoh D, Tanaka N. Effects of prophylactic splenic artery modulation on portal overperfusion and liver regeneration in small-for-size graft. Transplantation. 2008 Sep 15;86(5):673-80. doi: 10.1097/TP.0b013e318181e02d.'}, {'pmid': '12717222', 'type': 'BACKGROUND', 'citation': 'Ito T, Kiuchi T, Yamamoto H, Oike F, Ogura Y, Fujimoto Y, Hirohashi K, Tanaka AK. Changes in portal venous pressure in the early phase after living donor liver transplantation: pathogenesis and clinical implications. Transplantation. 2003 Apr 27;75(8):1313-7. doi: 10.1097/01.TP.0000063707.90525.10.'}, {'pmid': '19718645', 'type': 'BACKGROUND', 'citation': 'Jiang SM, Zhou GW, Zhang R, Peng CH, Yan JQ, Wan L, Shen C, Chen H, Li QY, Shen BY, Li HW. Role of splanchnic hemodynamics in liver regeneration after living donor liver transplantation. Liver Transpl. 2009 Sep;15(9):1043-9. doi: 10.1002/lt.21797.'}, {'pmid': '12783396', 'type': 'BACKGROUND', 'citation': 'Garcia-Valdecasas JC, Fuster J, Charco R, Bombuy E, Fondevila C, Ferrer J, Ayuso C, Taura P. Changes in portal vein flow after adult living-donor liver transplantation: does it influence postoperative liver function? Liver Transpl. 2003 Jun;9(6):564-9. doi: 10.1053/jlts.2003.50069.'}, {'pmid': '21542130', 'type': 'RESULT', 'citation': 'Wu TJ, Dahiya D, Lee CS, Lee CF, Chou HS, Chan KM, Lee WC. Impact of portal venous hemodynamics on indices of liver function and graft regeneration after right lobe living donor liver transplantation. Liver Transpl. 2011 Sep;17(9):1035-45. doi: 10.1002/lt.22326.'}]}, 'descriptionModule': {'briefSummary': "In this study, the investigators aim to prove that performing splenic artery ligation in living donor liver transplantation for patients with portal hypertension is beneficial for early graft function postoperatively. The investigators will be analyzing trend of LFT's (liver function tests) after surgery, time for normalization of bilirubin, INR (international normalised ratio) and decrease in ascites, morbidity, mortality, ICU (intensive care unit) and total hospital stay.", 'detailedDescription': 'Liver transplantation (LT) is the principal treatment for end-stage liver diseases and selected cases of liver neoplasms . Living donor liver transplantation (LDLT) serves as a sole source of liver graft in some countries that do not allow donation from deceased donors for cultural, social, or religious reasons.\n\nHyperperfusion plays an important role in liver regeneration after LDLT, but it may induce injury in the graft . After the reperfusion of a partial graft, there is a significant increase in the portal flow, but Hepatic artery flow remains constant . Excessive portal vein flow may induce injuries in grafts and may contribute to poor graft function.\n\nFor satisfactory graft function early after LT, the portal vein pressure (PVP) value after reperfusion should be \\<15 mm Hg. PVP is the most important hemodynamic factor influencing the functional status of the liver and graft regeneration after LT.\n\nThe use of Splenic Artery Ligation (SAL) as a simple and safe method to modulate portal flow has been reported .\n\nThe investigators will evaluate that Splenic artery ligation in living donor liver transplantation for patients with Portal hypertension is feasible and efficient technique to improve early graft function and to decrease morbidity and hospital stay and improve outcomes .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing Living Donor Liver Transplantation(LDLT) accepted according to hospital protocol.\n* Patients who have Portal Venous Pressure (PVP) \\> 15 mm Hg after reperfusion .\n\nExclusion Criteria:\n\n* Patients who have Portal Venous Pressure (PVP) \\> 15 mm Hg after reperfusion.\n* Patients who had splenectomy.\n* Patients who have splenic artery aneurysm.'}, 'identificationModule': {'nctId': 'NCT04988100', 'briefTitle': 'Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Splenic Artery Ligation in Living Donor Liver Transplantation for Patients With Portal Hypertension on Early Graft Function.', 'orgStudyIdInfo': {'id': 'GIM in LDLT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients who undergo Splenic artery ligation', 'description': 'If inclusion criteria are met, these group of patients will undergo splenic artery ligation .', 'interventionNames': ['Procedure: splenic artery ligation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No splenic artery ligation', 'description': 'If inclusion criteria are met, these group of patients will not undergo splenic artery ligation.', 'interventionNames': ['Procedure: No intervention']}], 'interventions': [{'name': 'splenic artery ligation', 'type': 'PROCEDURE', 'description': 'Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas', 'armGroupLabels': ['Patients who undergo Splenic artery ligation']}, {'name': 'No intervention', 'type': 'PROCEDURE', 'description': 'Splenic artery is not ligated despite the presence of portal hyperperfusion', 'armGroupLabels': ['No splenic artery ligation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdallah rashad', 'role': 'CONTACT', 'email': 'drabdallahtemerik@gmail.com', 'phone': '01015001867'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Abdallah Rashad Abdelaziz', 'investigatorAffiliation': 'Assiut University'}}}}