A Phase 4 interventional study of Arterial Flushing and Portal Flushing in Biliary Complications and Graft Function, Delayed, sponsored by Institute of Liver and Biliary Sciences, India. Completed. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Institute of Liver and Biliary Sciences, India · Phase 4, Interventional, and Prevention
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.
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.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 85 is close to the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
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Exclusion Criteria:
Back table flush of portal vein and graft artery
Procedure: Arterial Flushing · Procedure: Portal Flushing
Back table flush of portal vein only
Procedure: Portal Flushing
Effects on biliary complications
Occurence of biliary complication
Time frame: Three months
Hospital stay
Occurrence of complications
Time frame: 1 month
Morbidity
Time frame: 1 month
Effect on graft function
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Yes
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India →