Status:
ACTIVE_NOT_RECRUITING
Corticosteroid Effect on Achalasia Variant EGJOO
Lead Sponsor:
Baylor Research Institute
Conditions:
Esophagogastric Junction Outflow Obstruction
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
EGJOO is a disorder in which the muscles of the esophagus (swallowing tube) do not function in a coordinated fashion so that swallowed material does not pass easily into the stomach. EGJOO often cause...
Detailed Description
Esophagogastric junction outflow obstruction (EGJOO) is an esophageal motility disorder with a heterogeneous etiology. The optimal treatment for EGJOO is not known, and proper management of the condit...
Eligibility Criteria
Inclusion
- Adult patients age 18 years or older with the following clinical and diagnostic criteria will be eligible for study inclusion:
- EGJOO manometric diagnosis based on CC v4.0 criteria
- Primary symptom of dysphagia and/or non-cardiac chest pain
- Additional objective evidence of obstruction on Timed Barium Esophagram and/or EndoFLIP
- The treating physician has determined that invasive therapy (botulinum toxin injection, pneumatic dilation, POEM, or Heller myotomy) is indicated.
Exclusion
- History of prior foregut surgery
- History of esophageal botulinum toxin injection within 6 months of study enrollment
- Presence of hiatal hernia \> 2 centimeters
- Presence of esophageal mass
- Obstructing esophageal stricture or ring on endoscopy
- Reflux esophagitis (LA Grades B-D)
- Subjects on current immunosuppression or immune modulating therapy
- Chronic opioid use
- Previously diagnosed extrinsic compression of the gastroesophageal junction
- Concomitant Eosinophilic Esophagitis with uncontrolled mucosal disease who have not tried at least one standard therapy
- Contraindication to the use of oral corticosteroids
- History and/or current diagnosis of Diabetes
Key Trial Info
Start Date :
July 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06588348
Start Date
July 26 2022
End Date
January 1 2026
Last Update
September 19 2025
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246