Loading clinical trials...

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO. | Clinical Trials | Clareo Health

RECRUITINGNA

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

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

NCT06128018•AdventHealth

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

AdventHealth Orlando

Orlando, Florida, United States

Key Dates

Start Date

November 1, 2023

Primary Completion Date

December 1, 2025

Completion Date

July 31, 2026

Last Updated

March 8, 2024

Enrollment

ESTIMATED participants

Conditions

Malignant Gastric Outlet Obstruction

Interventions

Surgical gastrojejunostomy (S-GJ)

PROCEDURE

EUS-guided gastrojejunostomy (EUS-GJ)

PROCEDURE

Contacts

Diana Paredes

CONTACT

(407)303-9736 Diana.Paredes@adventhealth.com

Petronio Martins

CONTACT

(407)303-5503 Petronio.martins@adventhealth.com

Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

NCT05986890

Malignant Gastric Outlet Obstruction

View study

ENROLLING_BY_INVITATIONNA

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

NCT06567691

Malignant Gastric Outlet Obstruction

View study

COMPLETEDPHASE3

Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions