|- candidate number||1403|
|- NTR Number||NTR277|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Relevance of circulating tumor cells in patients undergoing laparoscopic colon resection versus open resection; a randomized trial.|
|- Scientific Title||Relevance of circulating tumor cells in patients undergoing laparoscopic colon resection versus open resection; a randomized trial.|
|- hypothesis||We hypothesize that free circulating tumor cells can be detected during surgery in patients with colorectal cancer. Since minimal invasive surgery causes less trauma and tumor manipulations we hypothesise that the amount of free circulating tumor 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 tumor shedding and compromises immune function, the minimally invasive surgery for colorectal cancer might both lower the risk of tumor shedding and result in less compromised immune down regulation resulting in better protection against tumor shedding. |
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer|
|- Inclusion criteria||1. Age between 40 and 80 years;|
2. colorectal cancer including colon and rectosigmoid cancers;
3. informed consent.
|- Exclusion criteria||1. Prior midline laparotomy;|
2. ASA III/IV;
3. Laparoscopic surgeon not available;
4. Prior upper and/or lower midline laparotomy;
5. Emergency colectomy;
6. Contraindications for epidural (coagulation disorders).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2005|
|- planned closingdate||1-sep-2006|
|- Target number of participants||30|
|- Interventions||Laparoscopic surgery compared to open surgery for colorectal cancer.|
|- Primary outcome||The amount of circulating tumor material induced by the surgical procedure, measured before, during and after the surgical procedure. |
|- Secondary outcome||The level of cytokines before, during and after the surgical procedure.
Differences in genotype between primary tumor and circulating tumor cells. |
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||M.D. J. Wind |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. W.A. Bemelman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background:|
Besides radical surgery, minimal manipulation of the tumor tissue is thought to be essential for the prognosis of patients with colorectal cancer. It is generally thought that lympho-vascular ligation before tumor manipulation reduces intra-operative dissemination of colorectal cancer cells, however evidence is scarce.
To eveluate the influence of laparoscopic surgery on the amount of circulating tumor cells and cancer biology.
Patients included in this study will be a subset of the contribution to the LAFA-trial. First, a pilot experiment will be conducted for which we will include 5 (lap) versus 5 patients (open) to test the experimental set up. In total this study is powered to include 30 patients (15 versus 15).
Blood will be collected by venapuncture and by inserting a catheter in a large draining mesenterical vene according standard conditions.
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 9-dec-2008|