Ischaemic preconditioning in liver resections studied with microdialysis

ISRCTN	ISRCTN29593599
DOI	https://doi.org/10.1186/ISRCTN29593599
Protocol serial number	N/A
Sponsor	The Bengt Ihre Foundation (Sweden)
Funders	The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden), The Bengt Ihre Foundation (Sweden) - through the Swedish Society of Medicine

Submission date: 09/02/2009
Registration date: 27/03/2009
Last edited: 09/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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 Anders Winbladh
Scientific

Department of Surgery
University Hospital
Linköping
581 85
Sweden

Study information

Primary study design	Interventional
Study design	Randomised single-blinded single-centre controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Ischaemic preconditioning in liver resections studied with microdialysis: a randomised single-blinded single-centre controlled trial
Study objectives	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(s)	Regional ethics committee in Linköping Sweden gave approval in June 2006 (ref: M100-06)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	21/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	32
Key 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
Key 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
Date of first enrolment	01/02/2008
Date of final enrolment	21/09/2009

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Surgery

Linköping
581 85
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes