A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction
AdventHealth
Summary
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 anat…
Interventions
- ProcedureSurgical gastrojejunostomy (S-GJ)
Surgical gastro-jejunostomy
- ProcedureEUS-guided gastrojejunostomy (EUS-GJ)
Endoscopic Ultrasound guided gastro-jejunostomy
Location
- AdventHealth OrlandoOrlando, Florida