Backflow hepatic arterial flush of liver graft by hepatic vein occlusion in living donor liver tranplantation

ISRCTN	ISRCTN55021745
DOI	https://doi.org/10.1186/ISRCTN55021745
Protocol serial number	97-04-10
Sponsor	Taipei Veterans General Hospital (Taiwan)
Funder	Taipei Veterans General Hospital (Taiwan) - research grant (ref: TVGH 98, S22-004)

Submission date: 01/10/2010
Registration date: 19/10/2010
Last edited: 19/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chinsu Liu
Scientific

No. 201, Sec. 2, Shih-Pai Rd.
Taipei Veterans General Hospital
Taipei
112
Taiwan

Study information

Primary study design	Interventional
Study design	Interventional single-blind single centre randomised study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Retrograde arterial flush of the liver graft in living donor liver transplantation: a prospective randomised study
Study objectives	Formal arterial flush of graft during recovery procedures in living donor liver transplantation (LDLT) is usually not performed, so the beneficial effects of arterial flush in LDLT is not well known. The aim of this study was to evaluate the effects of arterial flush of graft in LDLT by using retrograde arterial flush (RGAF) of liver graft which prevented the injury of arterial intima.
Ethics approval(s)	Institutional review board of Veterans General Hospital, Taipei, approved on the 16th May 2008
Health condition(s) or problem(s) studied	Liver transplantation
Intervention	After complete parenchymal dissection of the donor liver and cutting the bile duct, intravenous heparin (2000 U) was given to the donor. Two minutes after heparin injection, the graft was quickly removed into the iced basin with transient warm ischaemia which was always less than 5 minutes. In the non-RGAF group, the graft was flushed via the portal vein with 3 times the graft weight (g) of chilled histidine-tryptophan-ketoglutarate (HTK) solution under gravity at a height of 1 metre in the back table. The bile duct and hepatic artery was flushed gently by 5 cc HTK solution using a 24 gauge catheter. In the RGAF group, the graft was first flushed via the portal vein with 2 times the graft weight (g) of chilled HTK solution as non-RGAF group and then the hepatic vein(s) is (are) clamped by delicate Pott's vascular clamp(s) and the graft was flushed via the portal vein with 500 cc chilled HTK solution (200 cc for left lateral segment). Then the vascular clamp(s) was (were) released. The procedure of retrograde flush was repeated until the effluent from hepatic vein became clear. The bile duct was flushed gently by 5 cc HTK solution using a 24 gauge catheter. For both groups, the reconstructions of the vessels and bile ducts of the graft were performed thereafter if necessary.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Intra-operative haemodynamic changes 2. One-month post-transplantational liver function tests 3. Occurrence rates of acute cellular rejection within first month after transplantation 4. Immediate preservation injuries of the graft livers by retrograde arterial perfusion
Key secondary outcome measure(s)	1. Rates of vascular and biliary complications 2. Length of post-operative hospital stay 3. Graft and patient survival rates
Completion date	10/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Donors' ages range from 18 to 65 years 2. Recipients' aged under 70 years according to the law in Taiwan
Key exclusion criteria	1. Retransplantation 2. Small- or large-sized grafts (graft-versus-recipient weight ratio, GRWR less than 0.8%, or greater than 5%) 3. Recipients with complete portal vein thrombosis 4. Recipients needing renal replacement therapy before LDT
Date of first enrolment	20/06/2006
Date of final enrolment	10/10/2010

Locations

Countries of recruitment

Taiwan

Study participating centre

No. 201, Sec. 2, Shih-Pai Rd.

Taipei
112
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes