Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

Biliary Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048318
• Other study ID #: ILBS-ArterialFlush-001
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2017
• Last updated: June 28, 2017
• Start date: October 1, 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: January 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Complications
• Delayed Graft Function
• Flushing
• Graft Function, Delayed

Intervention

Procedure:
• Arterial Flushing

• Portal Flushing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on biliary complications	Occurence of biliary complication	Three months
Secondary	Hospital stay	Occurrence of complications	1 month
Secondary	Morbidity		1 month
Secondary	Effect on graft function		3 months