Condition category
Cancer
Date applied
09/02/2009
Date assigned
27/03/2009
Last edited
09/12/2009
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 Anders Winbladh

ORCID ID

Contact details

Department of Surgery
University Hospital
Linköping
581 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Ischaemic preconditioning in liver resections studied with microdialysis: a randomised single-blinded single-centre controlled trial

Acronym

Study hypothesis

Does ischaemic preconditioning before 15/5 Pringles manoeuvre change metabolism or ischaemia-reperfusion injury compared to 15/5 Pringles manoeuvre alone in surgical liver resections?

As of 09/12/2009 this record has been updated to the actual end date of trial recruitment - the initial anticipated end date for this trial was 30/04/2009.

Ethics approval

Regional ethics committee in Linköping Sweden gave approval in June 2006 (ref: M100-06)

Study design

Randomised single-blinded single-centre controlled trial

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 tumour

Intervention

All patients will receive intrahepatic microdialysis catheters intra-operatively. Pringle manoeuvre means closure of the portal pedicle. The treatment arm will begin surgery with 10 minutes of Pringle and then 10 minutes of reperfusion (i.e. ischaemic preconditioning) will be allowed before regular 15 minutes of ischaemia and 5 minutes of reperfusion in cycles until the transsection is finished.

The control arm will not have preconditioning, otherwise Pringle will be used in the same manner.

Both arms are followed for 5 days post-operatively with microdialysis and laboratory testing and then a follow-up visit is held at the outpatient clinic about 30-days post-operatively where complications and pathological diagnosis is documented.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Changes in metabolism (anaerobic/aerobic), studied with microdialysis
2. Ischaemia-reperfusion injury (histology, myeloperoxidase [MPO], etc)

Results of the microdialysis samples are recorded continuously for 5 days post-operatively (and blood samples daily for 5 days), but data are not compiled and analysed until the last study participant has completed the 30-day follow-up time.

Secondary outcome measures

Extent of the resected liver volume, recorded continuously and the volume of resection will be recorded immediately after the operation. Data are not compiled and analysed until the last study participant has completed the 30-day follow-up time.

Overall trial start date

01/02/2008

Overall trial end date

21/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than 17 years of age (either sex)
2. Suspected malignant tumour in the liver
3. Assigned to curative liver resection of more than one liver segment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Synchronous resection of another hollow viscus
2. Jaundice (bilirubin greater than 60 mM)
3. Ongoing infection
4. Child's B or worse

Recruitment start date

01/02/2008

Recruitment end date

21/09/2009

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Surgery
Linköping
581 85
Sweden

Sponsor information

Organisation

The Bengt Ihre Foundation (Sweden)

Sponsor details

Swedish Society of Medicine
Box 73
Stockholm
101 35
Sweden

Sponsor type

Charity

Website

http://www.sls.se/svls.cs

Funders

Funder type

Research council

Funder name

The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Bengt Ihre Foundation (Sweden) - through the Swedish Society of Medicine

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