Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-16 @ 3:56 PM
Study NCT ID:
NCT05385120
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomised Pilot study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-05-19', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure between two groups at fixed time points', 'timeFrame': 'T0- At the beginning of the procedure', 'description': 'Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg'}, {'measure': 'Ionotropes requirement between two groups at fixed time points', 'timeFrame': 'T0- At the beginning of the procedure', 'description': 'Noradrenaline and Vasopressin requirement in milliliter/hour'}, {'measure': 'Lactate level between two groups at fixed time points', 'timeFrame': 'T0- At the beginning of the procedure', 'description': 'Lactate levels are documented from Arterial Blood Gas analysis'}, {'measure': 'Blood Pressure between two groups at fixed time points', 'timeFrame': 'T1- During procedure- Before portocaval shunt formation', 'description': 'Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmHg'}, {'measure': 'Ionotropes requirement between two groups at fixed time points', 'timeFrame': 'T1- During procedure- Before portocaval shunt formation', 'description': 'Noradrenaline and Vasopressin requirement in milliliter/hour'}, {'measure': 'Lactate level between two groups at fixed time points', 'timeFrame': 'T1- During procedure- Before portocaval shunt formation', 'description': 'Lactate levels are documented from Arterial Blood Gas analysis'}, {'measure': 'Blood Pressure between two groups at fixed time points', 'timeFrame': 'T2- During procedure- Just Before Reperfusion of graft liver', 'description': 'Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg'}, {'measure': 'Ionotropes requirement between two groups at fixed time points', 'timeFrame': 'T2- During procedure- Just Before Reperfusion of graft liver', 'description': 'Noradrenaline and Vasopressin requirement in milliliter/hour'}, {'measure': 'Lactate level between two groups at fixed time points', 'timeFrame': 'T2- During procedure- Just Before Reperfusion of graft liver', 'description': 'Lactate levels are documented from Arterial Blood Gas analysis'}, {'measure': 'Blood Pressure between two groups at fixed time points', 'timeFrame': 'T3- During procedure- 5 minutes after reperfusion of graft liver', 'description': 'Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg'}, {'measure': 'Ionotropes requirement between two groups at fixed time points', 'timeFrame': 'T3- During procedure- 5 minutes after reperfusion of graft liver', 'description': 'Noradrenaline and Vasopressin requirement in milliliter/hour'}, {'measure': 'Lactate level between two groups at fixed time points', 'timeFrame': 'T3- During procedure- 5 minutes after reperfusion of graft liver', 'description': 'Lactate levels are documented from Arterial Blood Gas analysis'}, {'measure': 'Blood Pressure between two groups at fixed time points', 'timeFrame': 'T4- During procedure- Before closure of abdomen', 'description': 'Systolic Blood pressure, Diastolic Blood Pressure and Mean Blood Pressure is measured in mmhg'}, {'measure': 'Ionotropes requirement between two groups at fixed time points', 'timeFrame': 'T4- During procedure- Before closure of abdomen', 'description': 'Noradrenaline and Vasopressin requirement in milliliter/hour'}, {'measure': 'Lactate level between two groups at fixed time points', 'timeFrame': 'T4- During procedure- Before closure of abdomen', 'description': 'Lactate levels are documented from Arterial Blood Gas analysis'}, {'measure': 'Blood loss between two groups during intraoperative period', 'timeFrame': 'During Procedure', 'description': 'Blood loss during the procedure is measured in milliliter'}, {'measure': 'Duration of surgery between two groups.', 'timeFrame': 'During Procedure', 'description': 'Duration between incision time to closure of abdomen is noted in minutes'}, {'measure': 'Increase in creatinine levels of Increase 1.5-1.9 times from baseline in the post op period.', 'timeFrame': 'Number of days post transplantation procedure (upto 45 days)', 'description': 'Serum Creatinine is measured in milligram per deciliter'}, {'measure': '≥0.3 mg/dl increase within 48 h or Urine output < 0.5 ml/kg/h for 6-12 h in the post op period.', 'timeFrame': 'Number of days post transplantation procedure (upto 45 days)', 'description': 'Serum Creatinine is measured in milligram per deciliter'}, {'measure': 'Urine output between two groups', 'timeFrame': 'During Transplantation procedure', 'description': 'Urine output during the transplantation procedure is measured in milliliter'}], 'secondaryOutcomes': [{'measure': 'To compare tolerance to enteral feed between two groups', 'timeFrame': 'Number of days post transplantation procedure (upto 45 days)', 'description': 'Tolerance to NG feed is defined by absence of bloating, nausea, vomiting, abdominal distention or ileus'}, {'measure': 'Endotoxin levels', 'timeFrame': 'Levels of Serum endotoxin levels in pre op and 12 hours after surgery', 'description': 'Serum endotoxin levels increases in cases of bowel congestion and hemodynamic instability when portal vein is clamped during recipient hepatectomy'}, {'measure': 'Number of patients with Early allograft dysfunction', 'timeFrame': 'For 5 consecutive days after day 7', 'description': 'Early allograft dysfunction using criteria defined - total bilirubin \\>10 mg/dL, INR \\>1.6 and serum urea \\>100 mg/dL, for five consecutive days after day 7'}, {'measure': 'Incidence of Morbidity', 'timeFrame': 'Number of days post transplantation procedure (upto 45 days)', 'description': 'Morbidity is defined by Clavein Dindo Classification - \\>/=3. Sepsis as defined by Sepsis- 3 criteria, presence of 2 or more of the following 1.altered mentation, 2.respiratory rate ≥22 breaths/min 3.systolic blood pressure ≤100 mm Hg'}, {'measure': 'Incidence of sepsis', 'timeFrame': 'Number of days post transplantation procedure (upto 45 days)', 'description': 'Morbidity is defined by Clavein Dindo Classification - \\>/=3. Sepsis as defined by Sepsis- 3 criteria, presence of 2 or more of the following 1.altered mentation, 2.respiratory rate ≥22 breaths/min 3.systolic blood pressure ≤100 mm Hg'}, {'measure': 'Number of days of ICU stay', 'timeFrame': 'Number of days post transplantation procedure (upto 45 days)', 'description': 'Day patient shifted from ICU to ward is documented as total ICU stay. Day patient is discharged from hospital is documented for total hospital stay'}, {'measure': 'Number of days of hospital stay', 'timeFrame': 'Number of days post transplantation procedure (upto 45 days)', 'description': 'Day patient shifted from ICU to ward is documented as total ICU stay. Day patient is discharged from hospital is documented for total hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporary Portocaval shunt', 'Recipient Hepatectomy', 'Liver transplantation'], 'conditions': ['Portosystemic Shunt']}, 'referencesModule': {'references': [{'pmid': '11679990', 'type': 'RESULT', 'citation': 'Figueras J, Llado L, Ramos E, Jaurrieta E, Rafecas A, Fabregat J, Torras J, Sabate A, Dalmau A. Temporary portocaval shunt during liver transplantation with vena cava preservation. Results of a prospective randomized study. Liver Transpl. 2001 Oct;7(10):904-11. doi: 10.1053/jlts.2001.27870.'}, {'pmid': '18675094', 'type': 'RESULT', 'citation': "Arzu GD, De Ruvo N, Montalti R, Masetti M, Begliomini B, Di Benedetto F, Rompianesi G, Di Sandro S, Smerieri N, D'Amico G, Vezzelli E, Iemmolo RM, Romano A, Ballarin R, Guerrini GP, De Blasiis MG, Spaggiari M, Gerunda GE. Temporary porto-caval shunt utility during orthotopic liver transplantation. Transplant Proc. 2008 Jul-Aug;40(6):1937-40. doi: 10.1016/j.transproceed.2008.06.001."}, {'pmid': '20875093', 'type': 'RESULT', 'citation': 'Ghinolfi D, Marti J, Rodriguez-Laiz G, Sturdevant M, Iyer K, Bassi D, Scher C, Schwartz M, Schiano T, Sogawa H, del Rio Martin J. The beneficial impact of temporary porto-caval shunt in orthotopic liver transplantation: a single center analysis. Transpl Int. 2011 Mar;24(3):243-50. doi: 10.1111/j.1432-2277.2010.01168.x. Epub 2010 Sep 28.'}, {'pmid': '25891713', 'type': 'RESULT', 'citation': 'Kim JD, Choi DL. Beneficial impact of temporary portocaval shunt in living-donor liver transplantation with a difficult total hepatectomy. Transplant Proc. 2015 Apr;47(3):694-9. doi: 10.1016/j.transproceed.2014.12.036.'}, {'pmid': '23237579', 'type': 'RESULT', 'citation': 'Pratschke S, Meimarakis G, Bruns CJ, Kaspar M, Prix N, Zachoval R, Guba M, Jauch KW, Loehe F, Angele MK. Temporary intraoperative porto-caval shunt: useless or beneficial in piggy back liver transplantation? Transpl Int. 2013 Jan;26(1):90-8. doi: 10.1111/tri.12007. Epub 2012 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients', 'detailedDescription': 'All patients satisfying the inclusion criteria, written informed consent will be taken and patients are randomized into intervention group ( Portocaval Shunt Group) and Non intervention group ( No Shunt Group).Patients from both the groups will be assessed for Hemodynamic parameters, Urine Output, Blood loss, blood products requirement , Duration of surgery during the procedure. They will be assessed for renal function, presence of sepsis, Morbidity, early graft dysfunction, ICU stay and total hospital stay in the post operative period.All patients will be followed up till discharge from hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) All Adult LDLT Recipients at ILBS, New Delhi\n\nExclusion Criteria:\n\n1. Acute Liver Failure as an indication for transplant\n2. Pediatric transplants\n3. Presence of Yerdel grade III and grade IV Portal vein thrombosis\n4. Presence of significant portosystemic shunting (greater than 10mm) in pre operative period.\n5. Patients who have undergone TIPS procedure.\n6. Hypercoagulable states like Budd-Chiari syndrome\n7. Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT05385120', 'briefTitle': 'To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation- A Prospective Randomised Pilot Study', 'orgStudyIdInfo': {'id': 'IEC/2021/91/MA04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A-Shunt group', 'description': 'Patients who undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation', 'interventionNames': ['Procedure: Temporary Portocaval Shunt']}, {'type': 'NO_INTERVENTION', 'label': 'Group B-No Shunt group', 'description': 'Patients who donot undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation'}], 'interventions': [{'name': 'Temporary Portocaval Shunt', 'type': 'PROCEDURE', 'description': 'In Temorary Portocaval Shunt Group (TPCS group), Hilar dissection( division of Hepatic artery, Bileduct) is followed by temporary portocaval shunt formation during recipient Hepatectomy.', 'armGroupLabels': ['Group A-Shunt group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Manoj Kumar YL, MBBS, MS', 'role': 'CONTACT', 'email': 'manojkumaryl91@gmail.com', 'phone': '9164313430'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}