Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

Phase 4

Completed

• Conditions: Graft Function, Delayed; Biliary Complications
• Interventions: Procedure: Arterial Flushing; Procedure: Portal Flushing

• Registration Number: NCT03048318
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Arterial flushing is a standard recommendation in deceased donor liver transplantation but not in living donor liver transplantation due to the risk of arterial intimal injury and short cold ischaemia time. There is recent evidence on benefit of retrograde arterial perfusion using hepatic venous occlusion and its benefits on post transplant cholestasis. However there is no data on antegrade arterial flushing.

Detailed Description

Biliary reconstruction has been labeled the "Achilles heel" of liver transplantation and is a common cause of postoperative morbidity and also mortality .Living donor liver transplantation (LDLT) has a higher incidence of biliary complications of up to 30% which is higher than Deceased Donor Liver Transplantation and does not seem to improve significantly with experience.The virtually unchanged incidence of biliary strictures suggests that they are not simply "technical" in origin, but probably represent a mucosa ischemic injury inherent in the transplantation procedure. The blood supply of the bile duct is mainly from the arterial system and skeletonisation of the duct during dissection impairs the blood supply rendering it ischemic.

Various donor maneuvers for better flushing and preserving peribiliary vascular plexus and biliary mucosa have been studied to decrease biliary complications. LDLT have advantages of haemodynamic stable donor and short cold ischemia but also has disadvantages of small graft size, small ducts, complicated reconstruction and absence of arterial flush. Conventional portal flush in animal livers could not remove warm blood from the arterial system and grafts without retrograde arterial flush had higher post operative bilirubin.With further studies in Living Donor Liver Transplant, it was concluded that retrograde flushing may ameliorate post operative cholestasis. There has not been data published on antegrade arterial flushing and its effect on biliary complications in Living Donor Liver Transplant. This study aims to compare back table graft arterial and portal flushing with portal flushing alone and evaluate biliary and arterial complications.

Arterial flushing has been made part of standard protocol at our institute and its safety established. There are centers which routinely perform back table arterial flush.

Study Timeline

• Study Start: 2015-10-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• All patients undergoing living donor liver transplant for decompensated chronic liver disease with right lobe grafts only

Exclusion Criteria

• Donor artery size less than 2 mm
• More than one donor artery
• GRWR <0.8
• ABO incompatible grafts
• Refusal to participate in the study
• Emergency transplants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arterial and Portal Flushing of Graft	Arterial Flushing	Back table flush of portal vein and graft artery
Arterial and Portal Flushing of Graft	Portal Flushing	Back table flush of portal vein and graft artery
Portal Flushing only of Graft	Portal Flushing	Back table flush of portal vein only

Primary Outcome Measures

Name	Time	Method
Effects on biliary complications	Three months	Occurence of biliary complication

Secondary Outcome Measures

Name	Time	Method
Hospital stay	1 month	Occurrence of complications
Effect on graft function	3 months
Morbidity	1 month