Purge Vs no Purge in Living Donor Liver Transplantation Recipients (PNP)

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemia Reperfusion Injury
• Intervention / Treatment: Procedure: Purge

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Liver transplantation project - Gastroenterology surgical center - Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Purge; 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
No Intervention: No 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, 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?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Amr M Yassen, MD, Mansoura Faculty of medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 30, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Liver transplantation; Ischemia reperfusion injury; Graft rinse
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury
• Other Study ID Numbers: Purge_LTX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO