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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  2. Primary endpoint revisedv7 Show 4 more changesShow less
    • Start date: Sep 15, 2022 to Sep 16, 2022
    • Secondary endpoints revised (16)
    • Study description expanded, about 76 words
    • Collaborators revised (5)
  3. Enrollment target: 70 to 74
    • Primary completion date: Dec 2024 to Jun 2025
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: 15 to 16
    v6
  4. Enrollment target: 62 to 70v5
  5. Enrollment target: 54 to 62v4
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  1. Enrollment target: 100 to 54
    • Collaborators: 2 to 5
    v3
  2. Enrollment target: 24 to 100v2 Show 5 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Aug 2024 to Dec 2024
    • Study completion date: Dec 2024 to Dec 2025
    • Secondary endpoints: 13 to 15
    • Collaborators expanded, about 5 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05548114
Lead Sponsor Orlando Health, Inc.
Collaborators: West Virginia University, Rush University, Asian Institute of Gastroenterology, India, Medanta, The Medicity, India, University of Hamburg-Eppendorf
Conditions
(from sponsor)		 Gastric Outlet Obstruction
Related terms Gastric Outlet Obstruction, Neoplasms
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov