Clinical trial NCT03223831: Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
Official title: Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unresectable Malignant Gastric Outlet Obstruction
Keywords: unresectable malignant gastric outlet obstruction
Partially covered pyloro-duodenal stents
uncovered pyloro-duodenal stents
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: Singapore General Hospital
name: Changi General Hospital
name: Baldota Institute of Digestive Diseases, Mumbai, India.
First posted: 2017-07-21
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Re-intervention rate
timeFrame: 1 year
Secondary outcomes:
measure: Technical success
timeFrame: 1 day
measure: Clinical success
timeFrame: 3 days
measure: Adverse events rate
timeFrame: 1 year
measure: Mortality
timeFrame: 30 days
measure: Gastric outlet obstruction scores (GOOS)
timeFrame: 1 year
measure: Stent dysfunction
timeFrame: 1 year
measure: Duration of stent patency
timeFrame: 1 year
measure: Quality of life assessment scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: anthoyteoh@surgery.cuhk.edu.hk
name: Anthony Teoh, FRCSEd(Gen
role: PRINCIPAL_INVESTIGATOR
References: