RecruitingNot Applicable

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

United States70 participantsStarted 2023-11-01

Plain-language summary

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 18 years of age.
✓. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
✓. GOOSS of 0 or 1
✓. BOTH surgical and endoscopic GJ are technically and clinically feasible
✓. 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).

✕. \< 18 years of age
✕. ECOG \>2
✕. Expected survival (determined by the treating oncologist) is less than 2 months.
✕. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
✕. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
✕. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
✕. 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)
✕. Pregnancy

Identify safety profile EUS-GJ

Timeframe: 24 Months

NCT IDNCT06128018

SponsorAdventHealth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-08

Diana Paredes