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 |
| Secondary identifying numbers | 97-04-10 |
- 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
Scientific
No. 201, Sec. 2, Shih-Pai Rd.
Taipei Veterans General Hospital
Taipei
112
Taiwan
Study information
| Study design | Interventional single-blind single centre randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 20/06/2006 |
| Completion date | 10/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
112
Taiwan
Sponsor information
Taipei Veterans General Hospital (Taiwan)
Hospital/treatment centre
Hospital/treatment centre
c/o Chen-Hsen Lee
Chairman Institutional Review Board
No. 201, Sec. 2, Shih-Pai Rd.
Taipei
112
Taiwan
| Website | http://homepage.vghtpe.gov.tw/~mre/goodexp/content.htm |
|---|---|
"ROR" |
https://ror.org/03ymy8z76 |
Funders
Funder type
Hospital/treatment centre
Taipei Veterans General Hospital (Taiwan) - research grant (ref: TVGH 98, S22-004)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
