Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
- Conditions
- Unresectable Malignant Gastric Outlet Obstruction
- Registration Number
- NCT03223831
- Lead Sponsor
- Chinese University of Hong Kong
- Brief 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.
- Detailed Description
This would be a prospective multi-centred double-blinded randomised controlled study including all patients suffering from malignant gastric outlet obstruction due unresectable primary gastro-duodenal or pancreatico-biliary malignancies. Five international institutions in Hong Kong, Singapore and India would participate in the study.
The procedure would be performed under conscious sedation or monitored anaesthesia. The patients would be randomised PCDS or UCDS after cannulation of the obstruction site is achieved with the guide-wire. The patients or assessors would be blinded to the type of stent that is inserted.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Re-intervention rate 1 year Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
- Secondary Outcome Measures
Name Time Method Duration of stent patency 1 year calculated from the time of stent placement to the time of stent dysfunction
Clinical success 3 days Improvement of at least 1 point in the GOOS within 3 days after stent insertion
Adverse events rate 1 year Graded according to the lexicon of endoscopic adverse events
Gastric outlet obstruction scores (GOOS) 1 year Scoring system for food intake
Stent dysfunction 1 year Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture
Technical success 1 day Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.
Quality of life assessment scores 1 year EORTC QLQ-C30
Mortality 30 days Death from any cause
Trial Locations
- Locations (1)
Chinese University of Hong Kong
🇨🇳Hong Kong, Hong Kong, China
Chinese University of Hong Kong🇨🇳Hong Kong, Hong Kong, China