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

NCT05548114 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Gastric Outlet Obstruction

Interventions

PROCEDURE

EUS-guided gastrojejunostomy

AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.

PROCEDURE

Surgical gastrojejunostomy

A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.

Sponsors & Collaborators

  • West Virginia University

    collaborator OTHER

  • Rush University

    collaborator OTHER

  • Asian Institute of Gastroenterology, India

    collaborator OTHER

  • Medanta, The Medicity, India

    collaborator OTHER

  • University of Hamburg-Eppendorf

    collaborator OTHER

  • Orlando Health, Inc.

    lead OTHER

Principal Investigators

  • Ji Young Bang, MD MPH · Orlando Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548114 on ClinicalTrials.gov