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NCT06128018NARecruiting

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

AdventHealth

Start Date

11/1/2023

Completion Date

3/8/2027

Summary

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

Detailed Description

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction. The main question this study aims to answer is: 1\. To compare the rates of procedure related adverse events (AE's) between patients undergoing Endoscopy Ultrasound-guided gastro-jejunostomy (EUS-GJ) and Surgical gastro-jejunostomy (S-GJ). Study participants will be randomized into one of the two standard procedures and followed for up to 12 months post procedure for collection of outcomes related data

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Surgical gastrojejunostomy (S-GJ)

PROCEDURE

EUS-guided gastrojejunostomy (EUS-GJ)

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Conditions

Malignant Gastric Outlet Obstruction

Locations

AdventHealth Orlando

Orlando, Florida 32804

United States