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
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