Comparing two methods for treating blocked stomach openings
A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction
NA · AdventHealth · NCT06128018
This study is testing which of two procedures, one done with an endoscope and the other through surgery, is safer and works better for people with blocked stomach openings caused by cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth (other) |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06128018 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to compare the outcomes of two procedures for managing malignant gastric outlet obstruction: Endoscopic Ultrasound-guided gastrojejunostomy (EUS-GJ) and Surgical gastrojejunostomy (S-GJ). Participants will be randomly assigned to one of the two procedures and will be monitored for up to 12 months to assess the rates of procedure-related adverse events. The study seeks to determine which method is safer and more effective for patients with this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with evidence of an obstructing neoplasm in the distal stomach or duodenum.
Not a fit: Patients with a poor prognosis or those who are candidates for potential surgical resection of their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safer and more effective management of malignant gastric outlet obstruction.
How similar studies have performed: While similar studies have explored gastrojejunostomy techniques, this specific comparison of EUS-GJ and S-GJ is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 18 years of age. 2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum. 3. GOOSS of 0 or 1 4. BOTH surgical and endoscopic GJ are technically and clinically feasible 5. Can understand and is willing to sign informed consent form prior to the initiation of any study procedures (or when applicable the subject's LAR). Exclusion Criteria: 1. \< 18 years of age 2. ECOG \>2 3. Expected survival (determined by the treating oncologist) is less than 2 months. 4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer) 5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy 6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization) 7. Anatomical factors that technically hinder EUS-GJ OR Surgical-GJ (diffuse tumor involvement in path of LAMS or surgery, surgically altered anatomy that interferes with the ability to perform an anastomosis etc) 8. Pregnancy
Where this trial is running
Orlando, Florida
- AdventHealth Orlando — Orlando, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Kambiz Kadkhodayan, MD — AdventHealth
- Study coordinator: Diana Paredes
- Email: Diana.Paredes@adventhealth.com
- Phone: (407)303-9736
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.
Conditions: Malignant Gastric Outlet Obstruction