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Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

NCT05548114•Orlando Health, Inc.

View on ClinicalTrials.gov

Summary

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

Detailed Description

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years
•2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
•3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
•4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy

Exclusion Criteria

•1. Age \< 18 years
•2. Intrauterine pregnancy
•3. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
•4. Unable to obtain consent for the procedure from either the patient or LAR
•5. Altered anatomy due to prior gastroduodenal surgery
•6. Presence of other adhesions or synchronous obstructive lesions in the small bowel
•7. Prior treatment for gastric outlet obstruction
•8. Presence of large volume malignant ascites

Locations (1)

Orlando Health

Orlando, Florida, United States

Key Dates

Start Date

September 16, 2022

Primary Completion Date

June 1, 2025

Completion Date

December 1, 2025

Last Updated

June 12, 2025

Enrollment

ACTUAL participants

Conditions

Gastric Outlet Obstruction

Interventions

EUS-guided gastrojejunostomy

PROCEDURE

Surgical gastrojejunostomy

PROCEDURE

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

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Malignant Gastric Outlet Obstruction

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RECRUITINGNA

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

NCT06128018

Malignant Gastric Outlet Obstruction

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ENROLLING_BY_INVITATIONNA

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

NCT06567691

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: June 12, 2025Data 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

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Inclusion Criteria

Exclusion Criteria

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

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

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

ComVi and D-type Stent in Malignant GOO