NCT06128018 Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
| NCT ID | NCT06128018 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AdventHealth |
| Condition | Malignant Gastric Outlet Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-09-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-11-01 with a primary completion date of 2026-09-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
Eligibility 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
Contact & Investigator
Kambiz Kadkhodayan, MD
PRINCIPAL INVESTIGATOR
AdventHealth
Frequently Asked Questions
Who can join the NCT06128018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Gastric Outlet Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06128018 currently recruiting?
Yes, NCT06128018 is actively recruiting participants. Contact the research team at Diana.Paredes@adventhealth.com for enrollment information.
Where is the NCT06128018 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT06128018 clinical trial?
NCT06128018 is sponsored by AdventHealth. The principal investigator is Kambiz Kadkhodayan, MD at AdventHealth. The trial plans to enroll 70 participants.