Status:
ACTIVE_NOT_RECRUITING
EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Gastric Outlet Obstruction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided ga...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 14 2026
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03259763
Start Date
October 26 2020
End Date
March 14 2026
Last Update
June 25 2025
Active Locations (9)
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1
Yale University
New Haven, Connecticut, United States, 06520
2
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Wake Forest Baptist University
Winston-Salem, North Carolina, United States, 27157
4
The Research Institute of McGill University Health Centre
Montreal, Quebec, Canada