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

Primary Purpose

Ischemia Reperfusion Injury

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Purge
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemia Reperfusion Injury focused on measuring Liver transplantation, Graft rinse, Ischemia reperfusion injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Liver transplantation project - Gastroenterology surgical center - Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Purge

No Purge

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2015
Last Updated
March 24, 2017
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02540447
Brief Title
Purge Vs no Purge in Living Donor Liver Transplantation Recipients
Acronym
PNP
Official Title
Graft Portal Reperfusion Without Purging Graft Preservative Solution In Living Donor Liver Transplantation. A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury
Keywords
Liver transplantation, Graft rinse, Ischemia reperfusion injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purge
Arm Type
Experimental
Arm Description
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.
Arm Title
No Purge
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Purge
Intervention Description
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
Primary Outcome Measure Information:
Title
Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure
Description
The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping
Time Frame
5 minutes post-reperfusion
Secondary Outcome Measure Information:
Title
Biliary Complications (Participants)
Description
Participants who developed biliary complications in three months period (Participant)
Time Frame
3 months
Title
Ischemia Reperfusion Injury
Description
incidence of ischemia reperfusion injury in the transplanted graft
Time Frame
7 days
Title
Post-operative Infectious Complications
Time Frame
30 days
Title
3 Months Mortality
Description
mortality within first 3 post-operative months
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Organizational Affiliation
Mansoura Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liver transplantation project - Gastroenterology surgical center - Mansoura university
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Purge Vs no Purge in Living Donor Liver Transplantation Recipients

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