|- candidate number||1206|
|- NTR Number||NTR125|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||22-aug-2005|
|- Secondary IDs||1206 |
|- Public Title||Colonic stenting or surgery in left sided colonic obstruction for disseminated incurable colorectal cancer: a multicenter randomised trial.
|- Scientific Title||Colonic stenting or surgery in left sided colonic obstruction for disseminated incurable colorectal cancer: a multicenter randomised trial.
|- ACRONYM||Stent-in I study|
|- hypothesis||Patient with incurable disseminated left-sided colonic cancer are better palliated by colonic stenting than surgery measured by hospital free survival in "good health"(WHO-score 0 or 1)
Colonic stenting is cost effective in patients with incurable disseminated left-sided colonic cancer.|
|- Healt Condition(s) or Problem(s) studied||Tumour, Colonic cancer |
|- Inclusion criteria||1. Left sided colonic cancer (from left flexure to > 10 cm of anus);|
2. Diagnosis histological proven;
3. No signs of double tumor;
4. Informed consent.
|- Exclusion criteria||1. Potentially curable disease;|
2. ASA IV or V;
4. Karnofsky index of < 50%.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-dec-2004|
|- planned closingdate||1-jan-2008|
|- Target number of participants||180|
|- Interventions||Surgical palliation versus "wait and see" policy and colonic stenting if obstruction is imminent.|
|- Primary outcome||1. Total hospital free survival in good health (corrected for days with a WHO performance status > 1);|
2. Integral costs (product of volume consumed care and prices of means (personnel, overhead, material and investments).
|- Secondary outcome||1. Procedural related hospital stay and mortality and morbidity;|
2. Efficacy of palliation of (imminent) obstruction (complaints, secondary operation or stent placement);
3. Quality of life.
|- Trial web site||http://www.stent-in.nl|
|- CONTACT FOR PUBLIC QUERIES||MD. Jeanin Hooft, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. W.A. Bemelman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Hepato- and Gastroenterology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Endoscopy(begin 2008) Stent-in I study|
|- Brief summary||Survival in patients with incurable colonic cancer is poor and is estimated at 9 months.|
Morbidity associated with surgery might jeopardize successful palliation of imminent obstruction and bleeding. After hospital discharge the patient has to recover from surgery and might not reach the preoperative condition anymore due to postoperative morbidity or progressive disease. Patients who had successful colonic stenting recover very quickly from the endoscopic procedure. However, little is known how effective palliative stenting is in terms of long term relief of obstructing symptoms and early and late procedural morbidity and mortality.
The object of this study is to compare palliative treatment of (imminent) left sided obstruction in incurable colonic cancer either by surgery or colonic stenting.
Primary efficacy parameters are hospital free survival in good health (corrected for performance status) and integral costs. Based on a mean survival of 40 + 6 weeks and a difference in hospital free survival in good health of 3 weeks in favour of colonic stenting a total of 170 patients have to be included.
|- Main changes (audit trail)|
|- RECORD||21-aug-2005 - 10-dec-2007|