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Surgery versus stent for malignant gastro-duodenal obstruction.


- candidate number1888
- NTR NumberNTR531
- ISRCTNISRCTN6702358
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR13-dec-2005
- Secondary IDs945-06-503 
- Public TitleSurgery versus stent for malignant gastro-duodenal obstruction.
- Scientific TitleSurgical gastrojejunostomy or endoscopic duodenal stent placement for the palliation of malignant gastric outlet obstruction: a randomized study.
- ACRONYMSUSTENT study
- hypothesisTo compare a surgical procedure (gastrojejunostomy, GJJ) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO)
- Healt Condition(s) or Problem(s) studiedGastric Outlet Obstruction (GOO)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate31-dec-2008
- Target number of participants150
- Interventions1. Duodenal stent placement; 2. Gastrojejunostomy.
- Primary outcomeTotal area under the survival curve, adjusted for the abillity to eat at least soft solids (GOOSS score of 2 or more).
- Secondary outcome1. 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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESIr. S.M. Jeurnink
- CONTACT for SCIENTIFIC QUERIESMD. 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
- PublicationsN/A
- Brief summaryObjective: 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)
- RECORD13-dec-2005 - 6-mrt-2006


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