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

Safety and efficacy of a new partially covered big-cup stent in malignant gastric outlet obstruction (CUBIC-study): a prospective multicenter study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28005

Enrollment

Registered

2012-08-02

Start date

2012-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant gastric outlet obstruction, stent placement, enteral stent, cholangiocarcinoma, duodenal cancer, gastric cancer, pancreatic cancer

Interventions

Endoscopic placement of a new partially covered big-cup stent in the duodenum for palliative treatment of malignant gastric outlet obstruction.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Stent patency.	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Contacts

Public ContactM.W. Berg, van den

Academic Medical Center, Dept. of Gastroenterology & Hepatology Room C2-310

M.W.vandenBerg@amc.uva.nl+31 (0)20 5668708

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)