Purge Vs no Purge in Living Donor Liver Transplantation Recipients

Not Applicable

Completed

• Conditions: Ischemia Reperfusion Injury
• Interventions: Procedure: Purge

• Registration Number: NCT02540447
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Study First Submitted: 2015-08-30
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Results First Submitted: 2015-09-05
• Results First Submitted QC: 2015-09-21
• Results First Posted: 2015-10-20
• Status Verified: 2016-12
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Purge	Purge	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Liver transplantation project - Gastroenterology surgical center - Mansoura university; 🇪🇬 Mansoura, Dakahlia, Egypt