Condition category
Surgery
Date applied
09/07/2007
Date assigned
10/08/2007
Last edited
10/08/2007
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

Prof Gerd Otto

ORCID ID

Contact details

Director of Transplantation and Hepatobiliopancreatic Surgery
University of Mainz
Langenbeckstr. 1
Mainz
55131
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2007-002 KKS

Study information

Scientific title

Acronym

Perfusionsstudie

Study hypothesis

Main question of the trial:
Does Ischaemic Type Biliary Lesions (ITBL) occur less frequently in a liver preserved by aortic perfusion plus ex situ arterial flushing than in a liver preserved by simple aortic perfusion?

Ethics approval

Received from the local ethics committee (Landesarztekammer Rheinland-Pfalz) on the 27th April 2007 (ref: 837.364.05 [5462]). The ethics committees of all other trial centres have to approve the study before the centres could start with their trial participation.

NOTE: In this study dealing with liver transplantation, only the Central Region of the German Foundation for Organ Transplantion (Region Mitte der Deutschen Stiftung Organtransplantation) is recruting. All other centres are "only" implanting the organs and making the follow-up.

Study design

Randomised, controlled, multicentre, parallel group, two-armed trial. The grafts will be delivered to the transplant centre in a blinded way.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Liver transplantation after preservation in brain-death organ donors

Intervention

Aortic in situ perfusion versus aortic in situ perfusion plus arterial back-table ex situ flushing.

At the beginning of the process of abdominal dissection, a tube is placed into the abdominal aorta (or into a common iliac artery). The perfusate (HTK [Histidine-Tryptophan-Ketoglutarate] solution) is connected to this tube. Usually a perfusion pressure of 100 to 150 cm water column is applied which is realised by elevation of the plastic bag containing the fluid. When the liver is dissected free in order to be retrieved the perfusion is started. At least 8000 ml of solution have to be used.

In the control group the approach of preservation is stopped at this point, the liver is retrieved, put into plastic bags containing preservation solution and is forwarded to the transplant centre of the respective patients to whom the graft was allocated by Eurotransplant.

In the case of additional ex-situ arterial perfusion, the liver is retrieved and placed into an ice water dish. There all branches of the hepatic artery are tied, a cannula is placed into the artery at is origin and the ex-situ perfusion is performed. For ex-situ perfusion, 300 ml of the perfusate at a pressure of 100 cm water column is used. After that procedure, the graft is forwarded in the identical way as for non-ex-situ perfused grafts.

The transplantation itself is going to be performed at the discretion of the respective centre. Follow-up will be six months.

Intervention type

Drug

Phase

Not Specified

Drug names

Histidine-Tryptophan-Ketoglutarate (HTK)

Primary outcome measures

Rate of ITBL six months after transplantation.

Secondary outcome measures

1. Rate of ITBL or death within six months after transplantation
2. Parenchymal function following transplantation
3. Documentation and analysis of adverse events

All secondary outcomes are measured within six months after transplantation.

Overall trial start date

09/07/2007

Overall trial end date

31/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

For the graft:
1. Liver graft retrieved in the Central Region of the German Foundation for Organ Transplantion (Region Mitte der Deutschen Stiftung Organtransplantation [DSO])
2. Donor 18 - 80 years
3. Graft allocation to a participating centre

For the recipient
1. Informed consent
2. Age 18 - 80 years
3. Standard criteria for liver transplantation (e.g. liver dysfunction because of cirrhosis, carcinoma)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

126 - 174 depending on the result of the interim

Participant exclusion criteria

For the graft:
1. Liver cirrhosis
2. Liver intoxication
3. Liver dysfunction
4. Liver trauma
5. Graft not transplantable (decision according to Standard Operating Procedures [SOP])
6. Liver split

For the recipient:
1. Standard criteria for liver transplantation

Recruitment start date

09/07/2007

Recruitment end date

31/10/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Director of Transplantation and Hepatobiliopancreatic Surgery
Mainz
55131
Germany

Sponsor information

Organisation

Johannes Gutenberg University of Mainz (Germany)

Sponsor details

University Mainz
Dekan des Fachbereiches Medizin
Obere Zahlbacher Str. 63
Mainz
55131
Germany

Sponsor type

University/education

Website

http://www.klinik.uni-mainz.de

Funders

Funder type

University/education

Funder name

Johannes Gutenberg University of Mainz (Germany)

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