To Compare the Outcome of Temporary Portocaval Shunt During Recipient Hepatectomy Versus No Shunt in Adult Elective Live Donor Liver Transplantation.
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
| Sponsors |
Lead Sponsor: Institute of Liver and Biliary Sciences, India |
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| Source | Institute of Liver and Biliary Sciences, India |
| Brief Summary | Temporary portocaval Shunt during recipient hepatectomy improves intra operative parameters and morbidity in LDLT recipients |
| Detailed Description | 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. |
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| Overall Status | Not yet recruiting | ||||||||||||||||||||||||||||||||||||||||||
| Start Date | 2022-05-25 | ||||||||||||||||||||||||||||||||||||||||||
| Completion Date | 2023-08-30 | ||||||||||||||||||||||||||||||||||||||||||
| Primary Completion Date | 2023-07-30 | ||||||||||||||||||||||||||||||||||||||||||
| Phase | N/A | ||||||||||||||||||||||||||||||||||||||||||
| Study Type | Interventional | ||||||||||||||||||||||||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 40 |
| Condition | |
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| Intervention |
Intervention Type: Procedure Intervention Name: Temporary Portocaval Shunt 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. Arm Group Label: Group A-Shunt group |
| Eligibility |
Criteria:
Inclusion Criteria: 1) All Adult LDLT Recipients at ILBS, New Delhi Exclusion Criteria: 1. Acute Liver Failure as an indication for transplant 2. Pediatric transplants 3. Presence of Yerdel grade III and grade IV Portal vein thrombosis 4. Presence of significant portosystemic shunting (greater than 10mm) in pre operative period. 5. Patients who have undergone TIPS procedure. 6. Hypercoagulable states like Budd-Chiari syndrome 7. Refusal to participate in the study Gender: All Minimum Age: 18 Years Maximum Age: 75 Years Healthy Volunteers: No |
| Overall Contact | Contact information is only displayed when the study is recruiting subjects. |
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| Verification Date |
2022-03-01 |
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| Responsible Party |
Type: Sponsor |
| Keywords | |
| Has Expanded Access | No |
| Number Of Arms | 2 |
| Arm Group |
Label: Group A-Shunt group Type: Experimental Description: Patients who undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation Label: Group B-No Shunt group Type: No Intervention Description: Patients who donot undergo temporary porto caval shunt (TPCS) during recipient hepatectomy in adult elective live donor liver transplantation |
| Patient Data | No |
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: A Randomised Pilot study Primary Purpose: Supportive Care Masking: None (Open Label) |
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