|- candidate number||1888|
|- NTR Number||NTR531|
|- Date ISRCTN created||14-feb-2006|
|- date ISRCTN requested||13-jan-2006|
|- Date Registered NTR||13-dec-2005|
|- Secondary IDs||945-06-503 |
|- Public Title||Surgery versus stent for malignant gastro-duodenal obstruction.
|- Scientific Title||Surgical gastrojejunostomy or endoscopic duodenal stent placement for the palliation of malignant gastric outlet obstruction: a randomized study.|
|- ACRONYM||SUSTENT study|
|- hypothesis||To compare a surgical procedure (gastrojejunostomy, GJJ) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO)|
|- Healt Condition(s) or Problem(s) studied||Gastric Outlet Obstruction (GOO)|
|- Inclusion criteria||1. Obstructive cancer (more than 25% of the circumference as seen by endoscopy) extending from the distal duodenum;
2. Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only);
3. Incurable or metastatic disease;
4. Informed consent.|
|- Exclusion criteria||1. Evidence of other strictures in the gastrointestinal (GI) tract;
2. Previous gastric, periampullary or duodenal surgery;
3. Previous (palliative) treatment for the same condition;
4. WHO performance score of 4 (patient is 100% of time in bed);
5. Unable to fill out quality of life questionnaires.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2006|
|- planned closingdate||31-dec-2008|
|- Target number of participants||150|
|- Interventions||1. Duodenal stent placement;
|- Primary outcome||Total area under the survival curve, adjusted for the abillity to eat at least soft solids (GOOSS score of 2 or more). |
|- Secondary outcome||1. Procedure-related (within 7 days) and long term (later than 7 days) minor and major complications;
2. Reinterventions or recurrent obstructions;
3. Survival, calculated from day of randomization;
4. Health related quality of life, including the perceived burden of the procedure, burden of reintervention and generic and disease specific HRQoL;
5. Cost and cost-effectiveness.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Ir. S.M. Jeurnink|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. P.D. Siersema|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Objective:
To compare a surgical procedure(gastrojejunostomy, GJJ) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO).
Randomized, multicenter study.
Patients with inoperable distal stomach, periampullary or duodenal carcinoma.
GJJ (laparoscopic or open) or duodenal stent placement.
1) Medical effects (ability to eat, complications, reinterventions,
survival), 2) Quality of life, and 3) Costs and Cost-effectiveness.
The sample size calculation is based on total time that patients are not able to eat at least a soft diet after both procedures. For this, a log transformation was performed. Assuming that stent patients are approximately 7 days earlier able to eat a soft diet after treatment, but develop more recurrent obstruction, 2x70 patients are needed for a 84% power at the 5% level (t-test). We will include 2x74 patients to compensate 5% lost to follow-up.
Chi-square test, t-test, Kaplan-Meier method/log rank test and non-parametric analyses with bootstrap techniques.
GJJ and stent placement will be compared in a cost-effectiveness analysis from a societal perspective, including hospital care, health care after discharge, and informal care. |
|- Main changes (audit trail)|
|- RECORD||13-dec-2005 - 6-mrt-2006|