Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

Antegrade Arterial and Portal Flushing Versus Portal Flushing Only of the Liver Graft in Living Donor Liver Transplantation and Its Effects on Biliary Complications and Graft Function: A Randomized Control Study

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.

Study Overview

• Status: Completed
• Conditions: Biliary Complications; Graft Function, Delayed
• Intervention / Treatment: Procedure: Arterial Flushing; Procedure: Portal 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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arterial and Portal Flushing of Graft; Back table flush of portal vein and graft artery	Procedure: Arterial Flushing; Procedure: Portal Flushing
Active Comparator: Portal Flushing only of Graft; Back table flush of portal vein only	Procedure: Portal Flushing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on biliary complications	Occurence of biliary complication	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity		1 month
Hospital stay	Occurrence of complications	1 month
Effect on graft function		3 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Rommel Sandhyav, MS, Institute of liver and Biliary Sciences; Principal Investigator: Viniyendra Pamecha, MS, FRSS, FEBS, Professor; Principal Investigator: Senthil Kumar, MS, FRCS, Additional Professor; Principal Investigator: Shridhar Sasturkar, MS, MCh, Assistant Professor; Principal Investigator: Piyush Kumar Sinha, MS, MCh, Assistant Professor

Publications and helpful links

General Publications

• Pamecha V, Sandhyav R, Sinha PK, Bharathy KGS, Sasturkar S. Antegrade Arterial and Portal Flushing Versus Portal Flushing Only for Right Lobe Live Donor Liver Transplantation-A Randomized Control Trial. Transplantation. 2018 Apr;102(4):e155-e162. doi: 10.1097/TP.0000000000002088.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Flushing; Delayed Graft Function
• Other Study ID Numbers: ILBS-ArterialFlush-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No