Intermittent Portal and Graft Purge in Living Donor Liver Transplantation

Not Applicable

• Conditions: Hypotension; Ischemia Reperfusion Injury
• Interventions: Other: bolus purge; Other: Intermittent purge

• Registration Number: NCT02845154
• Lead Sponsor: Mansoura University

Brief Summary

Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. The investigators will investigate the effect of acute conditioning of the recipients circulation to the vasoactive mediators in the graft as well as the congested intestine through intermittent purging of graft contents into the patient's systemic circulation in living donor liver transplantation.

Detailed Description

Patients are subjected to living donor liver transplantation. In this type of grafts, cold ischemia time is minimal and the graft contents of preservative solution are less than cadaveric grafts. The investigators in the current research use HTC as a preservative solution. These factors justified the possibility of purging the graft and portal blood contents into the patient systemic circulation. The exposure to these fluids in this trial will be in an intermittent manner: the portal vein will be declamped for 5 seconds followed by 30 seconds of portal clamping. This will be repeated twice. The primary outcome objective in this trial will be the incidence of post-reperfusion syndrome. Secondary objectives include the severity of PRS, the incidence and severity of ischemia-reperfusion injury, graft and patient's survival.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-27
• Status Verified: 2016-12
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-08
• Study Completion: 2017-11

Recruitment & Eligibility

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

Inclusion Criteria

• living donor liver transplantation recipients

Exclusion Criteria

• Non

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (bolus purge)	bolus purge	The portal vein clamp will be totally released after end of portal vein anastomosis and all graft and portal blood contents are allowed free and complete access to the systemic circulation via the inferior vena cave
Intermittent Purge	Intermittent purge	The portal clamp will be released in situ for 5 seconds to allow purge of the graft and portal contents into the systemic circulation, followed by 30 seconds of portal clamping again. This will be followed by another two cycles of 5 seconds declamping and 30 seconds clamping , then, the portal clamp will be completely released.

Primary Outcome Measures

Name	Time	Method
Post-reperfusion syndrome	5 minutes after portal declamping	Reduced Mean arterial blood pressure to the predefined value

Secondary Outcome Measures

Name	Time	Method
Severity of post-reperfusion syndrome	5 minutes after portal declamping	% decrease in Mean arterial blood pressure
One month patient mortality	one month post-operative	Mortality within one post-operative month
Graft ischemia reperfusion injury	one week post-operative	Pathological assessment of IR injury based on Suzuli score

Trial Locations

Locations (3)

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

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

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