Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction

Conditions
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Malignant Gastric Outlet Obstruction

Intervention / Treatment
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* Procedure: Surgical gastrojejunostomy (S-GJ)
* Procedure: EUS-guided gastrojejunostomy (EUS-GJ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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 Criteria: < 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EUS-guided gastrojejunostomy (EUS-GJ)<br>Patients on this arm will undergo the endoscopic procedure. | Procedure: Surgical gastrojejunostomy (S-GJ)<br>* Surgical gastro-jejunostomy<br>|
| Other: Surgical gastrojejunostomy (S-GJ)<br>Patients on this arm will undergo the surgical procedure. | Procedure: EUS-guided gastrojejunostomy (EUS-GJ)<br>* Endoscopic Ultrasound guided gastro-jejunostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify safety profile EUS-GJ | The severity of AEs will be determined using standard American Society of Gastrointestinal Endoscopy (ASGE) Lexicon and AGREE criteria (appendix) in the EUS-GJ group. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify safety profile for S-GJ | The severity of AEs will be determined using Claviden-Dindo classification of surgical complications in the S-GJ group. | 24 Months |