No registrations found.
ID
Source
Brief title
Health condition
malignant gastric outlet obstruction, stent placement, enteral stent, cholangiocarcinoma, duodenal cancer, gastric cancer, pancreatic cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Stent patency.
Secondary outcome
1. 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).
Background summary
N/A
Study objective
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.
Study design
Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months.
Intervention
Endoscopic placement of a new partially covered big-cup stent in the duodenum for palliative treatment of malignant gastric outlet obstruction.
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Room C2-310
M.W. Berg, van den
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5668708
M.W.vandenBerg@amc.uva.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3384 |
| NTR-old | NTR3555 |
| Other | METC AMC : W12_120 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |