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Endoscopic Stenting versus Operative Intervention in Malignant Gastric Outlet Obstruction.


- candidate number8736
- NTR NumberNTR2639
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2010
- Secondary IDs2010-042 / NL31101.078.09 METC / CCMO
- Public TitleEndoscopic Stenting versus Operative Intervention in Malignant Gastric Outlet Obstruction.
- Scientific TitleEndoscopic Stenting versus Operative Intervention in Malignant Gastric Outlet Obstruction.
- ACRONYMSTENTOP
- hypothesisDuodenal stent placement results in an improved oral intake in malignant gastric outlet obstruction compared to gastrojejunstomy. Oral intake is defined as the percentage of days alive within the first 24 weeks after intervention with an oral intake of at least soft solids.
- Healt Condition(s) or Problem(s) studiedMalignant gastric outlet obstruction
- Inclusion criteria1. Malignant neoplasm of peri-duodenal area;
2. Gastric Oulet Obstruction Scoring System (GOOSS, see below) ≤ 1;
3. Life expectancy ≥ 4 weeks;
4. Informed consent;
5. Age ≥ 18 years;
6. Physical condition allowing to undergo upper gastrointestinal endoscopy or surgery, depending on judgement of local anaesthesiologist.
- Exclusion criteria1. Potentially curable disease;
2. Pre-procedural evidence of additional strictures in the gastrointestinal tract beyond the level of the duodenum;
3. Previous gastrojejunostomy;
4. Previous treatment with self-expandable metal stent for same condition.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2010
- planned closingdate1-jul-2012
- Target number of participants100
- Interventions1. Duodenal self expandable metal stent (SEMS);
2. Gastrojejunostomy.
- Primary outcomePercentage of days alive within the first 24 weeks after intervention with an oral intake of at least soft solids (GOOSS ≥ 2).
- Secondary outcome1. Gut Function Score (GFS);
2. Technical success;
3. Length of procedure-related hospital stay;
4. Complication rate (including pain intensity using a numerical rating scale, NRS);
5. Recurrent obstruction and reintervention rate;
6. Quality of life (QoL);
7. Costs;
8. Survival.
- TimepointsFollow-up of 24 weeks, scheduled time points at a 2 week interval.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P. Didden
- CONTACT for SCIENTIFIC QUERIES P. Didden
- Sponsor/Initiator Erasmus Medical Center, Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Gastroenterology and Hepatology
- PublicationsN/A
- Brief summaryThis prospective, multi-center randomized controlled study aims to investigate which treatment modality is preferable in patients with an irresectable malignant gastric outlet obstruction: A clinical treatment strategy of endoscopic stent placement or a clinical treatment strategy of gastrojejunostomy. In both treatment groups 50 subjects will be included. Primary outcome is defined as the percentage of days alive within the first 24 weeks after intervention with an oral intake of at least soft solids. In case of biliary obstruction drainage will be achieved by placement of a self-expandable metal stent prior to enteral SEMS insertion. If possible a surgical biliary bypass will be performed simultaneously in patients undergoing gastrojejunostomy. This will be done in case of concomitant signs of biliary obstruction or recurrent stent dysfunction in the presence of biliary stent.
- Main changes (audit trail)
- RECORD5-dec-2010 - 17-dec-2010


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