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Veiligheid en effectiviteit van een nieuwe 'big-cup partially covered' stent als palliatieve behandeling van een kwaadaardige maaguitgangsobstructie.


- candidate number13193
- NTR NumberNTR3555
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2012
- Secondary IDsW12_120 METC AMC
- Public TitleVeiligheid en effectiviteit van een nieuwe 'big-cup partially covered' stent als palliatieve behandeling van een kwaadaardige maaguitgangsobstructie.
- Scientific TitleSafety and efficacy of a new partially covered big-cup stent in malignant gastric outlet obstruction (CUBIC-study): a prospective multicenter study.
- ACRONYMCUBIC
- hypothesisPlacement of this stent will achieve good technical and clinical success rates, that are at least comparable to previously reported results of studies with other stent-designs. Moreover a low re-obstruction rate is expected due to the new stent design. This subsequently may cause a low number of re-interventions and a prolongation of clinical success. In addition this may also be reflected in relatively high quality of life (QoL)-scores.
- Healt Condition(s) or Problem(s) studiedCholangiocarcinoma, Gastric carcinoma, Pancreatic cancer, Stent, Malignant gastric outlet obstruction
- Inclusion criteria1. Histological proven malignancy of the periduodenal area;
2. GOOSS-score of 0 (no oral intake), 1 (liquids only) or 2 (soft solids) (see table 1) and/or suffering from nausea or vomiting or early satiety;
3. Age of at least 18 years;
4. Informed consent.
- Exclusion criteria1. Potentially curable disease;
2. Obstruction of the proximal stomach;
3. Pre-procedural evidence for additional strictures in the small bowel or colon;
4. Previous treatment with a self-expanding metal stent for the same condition;
5. Unable to undergo upper gastrointestinal endoscopy;
6. Unable to fill out quality of life questionnaires.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2012
- planned closingdate1-aug-2014
- Target number of participants40
- InterventionsEndoscopic placement of a new partially covered big-cup stent in the duodenum for palliative treatment of malignant gastric outlet obstruction.
- Primary outcomeStent patency.
- Secondary outcome1. Technical success defined as successful placement and deployment of the stent across the stricture;
2. Clinical success defined as relief of symptoms compatible with GOO and/or an improvement of the GOOSS-score 1 week after stent placement;
3. Improvement of the GOOSS-score during total follow-up;
4. Procedure (for example perforation, bleeding and sepsis) and stent-related (for example stent migration, stent occlusion by tumor ingrowth, late onset perforation) complications including 30-day mortality;
5. Quality of life score (EORTC QLQ-C30 (version 3) combined with EQ-5D including the EQ-VAS);
6. WHO performance status;
7. Procedure-related hospitalization time (days);
8. Time until regain of oral intake (days);
9. Survival (days).
- TimepointsBaseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. M.W. Berg, van den
- CONTACT for SCIENTIFIC QUERIESMD. M.W. Berg, van den
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-aug-2012 - 13-aug-2012


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