Status:
RECRUITING
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
Lead Sponsor:
AdventHealth
Conditions:
Malignant Gastric Outlet Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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\...
Eligibility Criteria
Inclusion
- ≥ 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).
Exclusion
- \< 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06128018
Start Date
November 1 2023
End Date
July 31 2026
Last Update
March 8 2024
Active Locations (1)
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1
AdventHealth Orlando
Orlando, Florida, United States, 32804