Comparing two methods for treating gastric outlet obstruction caused by cancer
Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
This study is testing two different procedures to see which one helps cancer patients with gastric outlet obstruction feel better and eat more comfortably.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orlando Health, Inc. Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT05548114 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different procedures, EUS-guided gastrojejunostomy and surgical gastrojejunostomy, in patients suffering from malignant gastric outlet obstruction. The study will assess clinical outcomes such as symptom relief and quality of life for patients who are unable to maintain an oral diet due to this condition. Participants will be monitored for their ability to tolerate food intake and overall health improvements following the interventions. The trial seeks to determine which method provides better results for patients facing this serious complication of cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with gastric outlet obstruction due to inoperable malignancy.
Not a fit: Patients with prior gastroduodenal surgery or those with other obstructive lesions in the small bowel may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients with gastric outlet obstruction by identifying the more effective treatment method.
How similar studies have performed: Other studies have shown promising results with EUS-guided interventions, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy 3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only) 4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy Exclusion Criteria: 1. Age \< 18 years 2. Intrauterine pregnancy 3. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy 4. Unable to obtain consent for the procedure from either the patient or LAR 5. Altered anatomy due to prior gastroduodenal surgery 6. Presence of other adhesions or synchronous obstructive lesions in the small bowel 7. Prior treatment for gastric outlet obstruction 8. Presence of large volume malignant ascites
Where this trial is running
Orlando, Florida
- Orlando Health — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ji Young Bang, MD MPH — Orlando Health
- Study coordinator: Ji Young Bang, MD, MPH
- Email: jiyoung.bang@orlandohealth.com
- Phone: 321-841-2431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.