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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03048318
Enrollment
85
Registered
2017-02-09
Start date
2015-10-01
Completion date
2017-04-30
Last updated
2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Complications, Graft Function, Delayed

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.

Interventions

PROCEDUREArterial Flushing
PROCEDUREPortal Flushing

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Subsequent patients undergoing living donor liver transplant with right lobe grafts will be randomised

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effects on biliary complicationsThree monthsOccurence of biliary complication

Secondary

MeasureTime frameDescription
Hospital stay1 monthOccurrence of complications
Morbidity1 month
Effect on graft function3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026