Clinical trial NCT03048318: Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biliary Complications
Graft Function, Delayed
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subsequent patients undergoing living donor liver transplant with right lobe grafts will be randomised
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects on biliary complications
timeFrame: Three months
Secondary outcomes:
measure: Hospital stay
timeFrame: 1 month
measure: Morbidity
timeFrame: 1 month
measure: Effect on graft function
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Rommel Sandhyav, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor
name: Viniyendra Pamecha, MS, FRSS, FEBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Additional Professor
name: Senthil Kumar, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Shridhar Sasturkar, MS, MCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Piyush Kumar Sinha, MS, MCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.