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Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

NCT ID: NCT03048318

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Biliary Complications Graft Function, Delayed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subsequent patients undergoing living donor liver transplant with right lobe grafts will be randomised
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Arterial and Portal Flushing of Graft

Back table flush of portal vein and graft artery

Group Type EXPERIMENTAL

Arterial Flushing

Intervention Type PROCEDURE

Portal Flushing

Intervention Type PROCEDURE

Portal Flushing only of Graft

Back table flush of portal vein only

Group Type ACTIVE_COMPARATOR

Portal Flushing

Intervention Type PROCEDURE

Interventions

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Arterial Flushing

Intervention Type PROCEDURE

Portal Flushing

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rommel Sandhyav, MS

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Viniyendra Pamecha, MS, FRSS, FEBS

Role: PRINCIPAL_INVESTIGATOR

Professor

Senthil Kumar, MS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Additional Professor

Shridhar Sasturkar, MS, MCh

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Piyush Kumar Sinha, MS, MCh

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

References

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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.

Reference Type DERIVED
PMID: 29334530 (View on PubMed)

Other Identifiers

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ILBS-ArterialFlush-001

Identifier Type: -

Identifier Source: org_study_id