Relevance of circulating tumour cells in patients undergoing laparoscopic colon resection versus open resection: a randomised trial

ISRCTN ISRCTN28212149
DOI https://doi.org/10.1186/ISRCTN28212149
Secondary identifying numbers NTR277
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
18/11/2008
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 J. Wind
Scientific

Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5663170
Email J.Wind@amc.uva.nl

Study information

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymCTC-trial
Study objectivesWe hypothesise that free circulating tumour cells can be detected during surgery in patients with colorectal cancer. Since minimal invasive surgery causes less trauma and tumour manipulations we hypothesise that the amount of free circulating tumour cells is less compared to the level detected during open surgery in comparable patient groups. Minimal invasive surgery causes less severe impairment of the immune system compared to open surgery. Since the surgical trauma might enhance tumour shedding and compromises immune function, the minimally invasive surgery for colorectal cancer might both lower the risk of tumour shedding and result in less compromised immune down-regulation resulting in better protection against tumour shedding.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedColorectal cancer
InterventionLaparoscopic surgery compared to open surgery for colorectal cancer.
Intervention typeOther
Primary outcome measureThe amount of circulating tumour material induced by the surgical procedure, measured before, during and after the surgical procedure.
Secondary outcome measures1. The level of cytokines before, during and after the surgical procedure
2. Differences in genotype between primary tumour and circulating tumour cells
Overall study start date01/07/2005
Completion date01/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Key inclusion criteria1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent
Key exclusion criteria1. Prior midline laparotomy
2. American Society of Anaesthesiologists (ASA) grade III/IV
3. Laparoscopic surgeon not available
4. Prior upper and/or lower midline laparotomy
5. Emergency colectomy
6. Contraindications for epidural (coagulation disorders)
Date of first enrolment01/07/2005
Date of final enrolment01/09/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Other

Internal funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan