| - candidate number | 1888 |
| - NTR Number | NTR531 |
| - ISRCTN | ISRCTN6702358 |
| - 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 |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jan-2006 |
| - planned closingdate | 31-dec-2008 |
| - Target number of participants | 150 |
| - Interventions | 1. Duodenal stent placement; 2. Gastrojejunostomy. |
| - 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. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Ir. S.M. Jeurnink |
| - CONTACT for SCIENTIFIC QUERIES | MD. PhD. P.D. Siersema |
| - Sponsor/Initiator | Erasmus Medical Center |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | Objective: To compare a surgical procedure(gastrojejunostomy, GJJ) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO). Design: Randomized, multicenter study. Study population: Patients with inoperable distal stomach, periampullary or duodenal carcinoma. Intervention: GJJ (laparoscopic or open) or duodenal stent placement. Outcome measures: 1) Medical effects (ability to eat, complications, reinterventions, survival), 2) Quality of life, and 3) Costs and Cost-effectiveness. Power: 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. Analysis: Chi-square test, t-test, Kaplan-Meier method/log rank test and non-parametric analyses with bootstrap techniques. Economic evaluation: 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 |
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