EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
Gastric Outlet Obstruction
About this trial
This is an interventional treatment trial for Gastric Outlet Obstruction focused on measuring Gastroenterostomy, Gastric Outlet Obstruction, Cancer, Endosonography
Eligibility Criteria
Inclusion Criteria:
- Adult patients with malignant, symptomatic gastric outlet obstruction due to an unresectable malignant lesion
- Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)
- Age>= 18
Exclusion Criteria:
- Evidence of other strictures in the gastrointestinal (GI) tract
- Previous gastric, periampullary or duodenal surgery
- World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed)
- Unable to fill out quality of life questionnaire
- Unable to sign the informed consent
- Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal jejunum around the ligament of Treitz
- Large volume ascites
- Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other severe comorbidities
- Pregnant or breastfeeding women
- Uncorrectable coagulopathy defined by INR > 1.5 or platelet < 50000/µl
- Complete GOO evidenced by inability to either pass a wire across the stricture and/or inability to opacify small bowel distal to the malignant stricture
- Resectable or borderline resectable tumors
Sites / Locations
- Yale University
- The Johns Hopkins HospitalRecruiting
- NYU Langone Health
- Columbia University
- University of North Carolina
- Wake Forest Baptist UniversityRecruiting
- The Research Institute of McGill University Health CentreRecruiting
- Ecuadorian Institute of Digestive Diseases (IECED)Recruiting
- Asian Institute of GastroenterologyRecruiting
- Hospital Universitario Rio Hortega
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EUS-guided gastroenterostomy (EUS-GE)
Enteral Stenting (ES)
In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.