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Surgery versus stent for malignant gastro-duodenal obstruction.

Conditions
randomized, multicenter study
Registration Number
NL-OMON20885
Lead Sponsor
ZonMW
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
150
Inclusion Criteria

1. Obstructive cancer (more than 25% of the circumference as seen by endoscopy) extending from the distal duodenum;
2. Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only);
3. Incurable or metastatic disease;
4. Informed consent.

Exclusion Criteria

1. Evidence of other strictures in the gastrointestinal (GI) tract;
2. Previous gastric, periampullary or duodenal surgery;
3. Previous (palliative) treatment for the same condition;
4. WHO performance score of 4 (patient is 100% of time in bed);
5. Unable to fill out quality of life questionnaires.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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