PASSAGE Clinical Trial
- Conditions
- Unresectable malignant gastric outlet obstruction
- Registration Number
- jRCT2032220496
- Lead Sponsor
- Boston Scientific Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 51
Unresectable malignant duodenal obstruction confirmed by biopsy Eligible for endoscopic intervention GOOSS score of 0 or 1 18 years of age or older Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
Exclusion Criteria at informed consent Prior metallic stent placement for GOO Contraindicated to surgery and general anesthesia Neoplasm invading the target site of puncture in gastric and/or jejunum Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage Presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure Intervening gastric varices or vessels at the target site of stent insertion Ascites that may interfere the safety of the index procedure Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team) Vulnerable subject
Exclusion Criteria at the index procedure Guidewire does not cross the area of GOO EP-DB does not advance to the target site in jejunum The distance between the gastric wall and jejunal wall when visualized on ultrasound after saline is introduced into the space between the two inflated balloons of EP-DB is deemed about 2 cm or more
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - GOOSS 3 rate without MAE at 30 days post procedure
- Secondary Outcome Measures
Name Time Method