Status:
WITHDRAWN
Idiopathic Esophagogastric Junction Outflow Obstruction
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Esophagogastric Junction Disorder
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study compares two treatments for Idiopathic Esophagogastric Junction Outflow Obstruction: pneumatic dilation compared with expectant management, on symptoms and liquid barium emptying exams.
Detailed Description
The objectives of this study are to address these gaps in knowledge by: Performing a randomized controlled trial in patients with idiopathic EGJOO that compares treatment outcomes after pneumatic dil...
Eligibility Criteria
Inclusion
- Initial HRIM consistent with the diagnosis of EGJOO and mechanical esophageal obstruction has been excluded by prior upper endoscopy.
- EGJOO patients with a retained liquid barium column on TBE ≥5cm in height at 1 minute
- Patients must have symptomatic dysphagia
Exclusion
- Diseases that potentially could cause mechanical obstruction such as gastroesophageal reflux disease with erosive esophagitis, peptic stricture, cancer, eosinophilic esophagitis, prior fundoplication, adjustable gastric band surgery and hiatal hernias. Patients with any identifiable anatomic esophageal or gastric obstruction will be excluded from the study
- Patients with previous surgery on the esophagus or stomach
- Previous history of per oral endoscopic myotomy or prior pneumatic dilation
- History of gastroparesis
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04096703
Start Date
October 1 2021
End Date
February 1 2024
Last Update
March 4 2022
Active Locations (1)
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1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157