Comparing two methods for treating blocked stomach openings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• AdventHealth Orlando
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Kambiz Kadkhodayan, MD — AdventHealth
• Study coordinator: Bridget Miller, MPH, MS
• Email: bridget.miller@adventhealth.com
• Phone: (407)303-9736

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.