No registrations found.
ID
Source
Brief title
Health condition
incurable left-sided colonic cancer
Sponsors and support
Chaiman Board of Directors
PO Box 22660
1100 DD Amsterdam
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Intervention
Surgical palliation versus "wait and see" policy and colonic stenting if obstruction is imminent.
P.O. Box 22660
Jeanin Hooft, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
info@stent-in.nl
P.O. Box 22660
Jeanin Hooft, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
info@stent-in.nl
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;
3. Ileus;
4. Karnofsky index of < 50%.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL94 |
| NTR-old | NTR125 |
| Other | : 1206 |
| ISRCTN | ISRCTN01790428 |