EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
- Conditions
- Gastric Outlet Obstruction
- Registration Number
- NCT03259763
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Adult patients with malignant, symptomatic gastric outlet obstruction due to an<br> unresectable malignant lesion<br><br> - Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1<br> (liquids only)<br><br> - Age 18-80 years<br><br>Exclusion Criteria:<br><br> - Evidence of other strictures in the gastrointestinal (GI) tract<br><br> - Previous gastric, periampullary or duodenal surgery<br><br> - World Health Organization (WHO) performance score of 4 (patient is 100% of time in<br> bed)<br><br> - Unable to fill out quality of life questionnaire<br><br> - Unable to sign the informed consent<br><br> - Life expectancy of less than 3 months based on the endoscopist's opinion<br><br> - Cancer extending into the body of the stomach, 4th portion of the duodenum or<br> proximal jejunum around the ligament of Treitz<br><br> - Large volume ascites<br><br> - Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability,<br> severe pulmonary disease or other severe comorbidities<br><br> - Pregnant or breastfeeding women<br><br> - Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50000/µl<br><br> - Complete GOO evidenced by inability to either pass a wire across the stricture<br> and/or inability to opacify small bowel distal to the malignant stricture<br><br> - Resectable or borderline resectable tumors<br><br> - One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of<br> the endoscopist)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of gastric outlet obstruction recurrence
- Secondary Outcome Measures
Name Time Method Technical success rate;Clinical success rate;Length of procedure;Adverse events rate;Post-procedure length of hospital stay;Reintervention rate for recurrent gastric outlet obstruction;Quality of Life SF-36 questionnaire scoring;Overall survival rate;Time to recurrent gastric outlet obstruction;Gastric Outlet Obstruction Scoring system (GOOSS);Stent Dysfunction Rate;Duration of stent patency