CompletedPhase 3

Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

China116 participantsStarted 2017-08-01

Plain-language summary

To compare the efficacy of a novel partially covered (PC) versus uncovered (UC) pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We hypothesize that the use of PCDS could reduce the re-intervention rates when compared to UCDS.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive patients ≥ 18 years old * Confirmed unresectable gastro-duodenal or pancreatico-biliary malignancies * Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1 (appendix 1) 19 * Performance status ECOG ≤3 (appendix 2) Exclusion Criteria: * Prior metallic stent placement * Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder) * Life expectancy of less than 1 month * History of gastric surgery * Linitus plastica * Coagulation disorders * Pregnancy * Unable to give informed consent

What they're measuring

Re-intervention rate

Timeframe: 1 year

Trial details

NCT IDNCT03223831

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-01

View on ClinicalTrials.gov More Unresectable Malignant Gastric Outlet Obstruction trials