EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
Completed · Not applicable
Conditions studied: Gastric Outlet Obstruction
In brief
Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).
Key facts
- Study ID
- NCT03259763
- Run by
- Johns Hopkins University
- People needed
- 112
- Starts
- 2020-10-26
- Expected to finish
- 2026-01-15
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 18-80 years
You may not qualify if…
- 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
- Life expectancy of less than 3 months based on the endoscopist's opinion
- 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
- One of the two techniques (EUS-GE and ES) cannot be performed (at the discretion of the endoscopist)
Where it is running
- Yale University — New Haven, Connecticut, United States
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- Wake Forest Baptist University — Winston-Salem, North Carolina, United States
- The Research Institute of McGill University Health Centre — Montreal, Quebec, Canada
- Ecuadorian Institute of Digestive Diseases (IECED) — Guayaquil, Ecuador
- Hospital Prive des Peupliers — Paris, France
- Asian Institute of Gastroenterology — Hyderabad, India
- Emek Medical Center — Afula, Israel
- Hospital Universitario Rio Hortega — Valladolid, Spain
Full record on ClinicalTrials.gov
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