Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

NCT03048318 | Completed Phase 4 DMC

• 1 other identifier: ILBS-ArterialFlush-001
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary Complications; Graft Function, Delayed

Outcome Measures

Primary Outcomes (1)

• Effects on biliary complications

  Occurence of biliary complication

  Three months

Secondary Outcomes (3)

• Hospital stay

  1 month

• Morbidity

  1 month

• Effect on graft function

  3 months

Study Arms (2)

Arterial and Portal Flushing of Graft

EXPERIMENTAL

Back table flush of portal vein and graft artery

Procedure: Arterial Flushing; Procedure: Portal Flushing

Portal Flushing only of Graft

ACTIVE COMPARATOR

Back table flush of portal vein only

Procedure: Portal Flushing

Interventions

Arterial Flushing PROCEDURE

Arterial and Portal Flushing of Graft

Portal Flushing PROCEDURE

Arterial and Portal Flushing of Graft; Portal Flushing only of Graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing living donor liver transplant for decompensated chronic liver disease with right lobe grafts only

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Related Publications (1)

• 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.

  PMID: 29334530 DERIVED

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subsequent patients undergoing living donor liver transplant with right lobe grafts will be randomised

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 9, 2017
• Study Start: October 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share