Placement 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…
ID
Bron
Verkorte titel
Aandoening
malignant gastric outlet obstruction, stent placement, enteral stent, cholangiocarcinoma, duodenal cancer, gastric cancer, pancreatic cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Stent patency.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Placement 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.
Onderzoeksopzet
Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months.
Onderzoeksproduct en/of interventie
Endoscopic placement of a new partially covered big-cup stent in the duodenum for palliative treatment of malignant gastric outlet obstruction.
Publiek
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Wetenschappelijk
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3384 |
| NTR-old | NTR3555 |
| Ander register | METC AMC : W12_120 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |