Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048318
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.

Condition or disease Intervention/treatment Phase
Biliary Complications Graft Function, Delayed Procedure: Arterial Flushing Procedure: Portal Flushing Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subsequent patients undergoing living donor liver transplant with right lobe grafts will be randomised
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Arm Intervention/treatment
Experimental: Arterial and Portal Flushing of Graft
Back table flush of portal vein and graft artery
Procedure: Arterial Flushing
Procedure: Portal Flushing
Active Comparator: Portal Flushing only of Graft
Back table flush of portal vein only
Procedure: Portal Flushing



Primary Outcome Measures :
  1. Effects on biliary complications [ Time Frame: Three months ]
    Occurence of biliary complication


Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: 1 month ]
    Occurrence of complications

  2. Morbidity [ Time Frame: 1 month ]
  3. Effect on graft function [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048318


Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Layout table for investigator information
Principal Investigator: Rommel Sandhyav, MS Institute of Liver and Biliary Sciences
Principal Investigator: Viniyendra Pamecha, MS, FRSS, FEBS Professor
Principal Investigator: Senthil Kumar, MS, FRCS Additional Professor
Principal Investigator: Shridhar Sasturkar, MS, MCh Assistant Professor
Principal Investigator: Piyush Kumar Sinha, MS, MCh Assistant Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03048318    
Other Study ID Numbers: ILBS-ArterialFlush-001
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Flushing
Delayed Graft Function
Skin Manifestations
Pathologic Processes