Purge Vs no Purge in Living Donor Liver Transplantation Recipients

Study Overview
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Brief Summary
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The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients.

Detailed Description
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All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.

Official Title
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Graft Portal Reperfusion Without Purging Graft Preservative Solution In Living Donor Liver Transplantation. A Prospective Randomized Controlled Trial

Conditions
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Ischemia Reperfusion Injury

Intervention / Treatment
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* Procedure: Purge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program Exclusion Criteria: re-transplantation Previous upper abdominal operation Budd Chiari syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Purge<br>The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. | Procedure: Purge<br>* In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping<br>|
| No Intervention: No Purge<br>The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure | The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping | 5 minutes post-reperfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary Complications (Participants) | Participants who developed biliary complications in three months period (Participant) | 3 months | 
| Ischemia Reperfusion Injury | incidence of ischemia reperfusion injury in the transplanted graft | 7 days | 
| Post-operative Infectious Complications |  | 30 days | 
| 3 Months Mortality | mortality within first 3 post-operative months | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplantation, Graft rinse, Ischemia reperfusion injury