Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT
Primary Purpose
Biliary Complications, Graft Function, Delayed
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Arterial Flushing
Portal Flushing
Sponsored by
About this trial
This is an interventional prevention trial for Biliary Complications
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arterial and Portal Flushing of Graft
Portal Flushing only of Graft
Arm Description
Back table flush of portal vein and graft artery
Back table flush of portal vein only
Outcomes
Primary Outcome Measures
Effects on biliary complications
Occurence of biliary complication
Secondary Outcome Measures
Hospital stay
Occurrence of complications
Morbidity
Effect on graft function
Full Information
NCT ID
NCT03048318
First Posted
January 31, 2017
Last Updated
June 28, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03048318
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Complications, Graft Function, Delayed
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Subsequent patients undergoing living donor liver transplant with right lobe grafts will be randomised
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arterial and Portal Flushing of Graft
Arm Type
Experimental
Arm Description
Back table flush of portal vein and graft artery
Arm Title
Portal Flushing only of Graft
Arm Type
Active Comparator
Arm Description
Back table flush of portal vein only
Intervention Type
Procedure
Intervention Name(s)
Arterial Flushing
Intervention Type
Procedure
Intervention Name(s)
Portal Flushing
Primary Outcome Measure Information:
Title
Effects on biliary complications
Description
Occurence of biliary complication
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Occurrence of complications
Time Frame
1 month
Title
Morbidity
Time Frame
1 month
Title
Effect on graft function
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rommel Sandhyav, MS
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Viniyendra Pamecha, MS, FRSS, FEBS
Organizational Affiliation
Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Senthil Kumar, MS, FRCS
Organizational Affiliation
Additional Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shridhar Sasturkar, MS, MCh
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piyush Kumar Sinha, MS, MCh
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
29334530
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.
Results Reference
derived
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Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT
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