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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
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Biliary Complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 31, 2017
    Last Updated
    June 28, 2017
    Sponsor
    Institute of Liver and Biliary Sciences, India
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    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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