Condition category
Surgery
Date applied
01/10/2010
Date assigned
19/10/2010
Last edited
19/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chinsu Liu

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

97-04-10

Study information

Scientific title

Retrograde arterial flush of the liver graft in living donor liver transplantation: a prospective randomised study

Acronym

Study hypothesis

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

Institutional review board of Veterans General Hospital, Taipei, approved on the 16th May 2008

Study design

Interventional single-blind single centre randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

1. Rates of vascular and biliary complications
2. Length of post-operative hospital stay
3. Graft and patient survival rates

Overall trial start date

20/06/2006

Overall trial end date

10/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Donors' ages range from 18 to 65 years
2. Recipients' aged under 70 years according to the law in Taiwan

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

20/06/2006

Recruitment end date

10/10/2010

Locations

Countries of recruitment

Taiwan

Trial participating centre

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

Sponsor information

Organisation

Taipei Veterans General Hospital (Taiwan)

Sponsor details

c/o Chen-Hsen Lee
Chairman Institutional Review Board
No. 201
Sec. 2
Shih-Pai Rd.
Taipei
112
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://homepage.vghtpe.gov.tw/~mre/goodexp/content.htm

Funders

Funder type

Hospital/treatment centre

Funder name

Taipei Veterans General Hospital (Taiwan) - research grant (ref: TVGH 98, S22-004)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes