Idiopathic Esophagogastric Junction Outflow Obstruction

Not Applicable

Withdrawn

• Conditions: Esophagogastric Junction Disorder
• Interventions: Procedure: Pneumatic dilation

• Registration Number: NCT04096703
• Lead Sponsor: Wake Forest University Health Sciences

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 dilation versus expectant management (disease controls) (expectant management). And, determining rational physiological and objective measures of treatment response.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2021-10
• Status Verified: 2021-11
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumatic dilation of EGJOO Group	Pneumatic dilation	The participants randomized to the pneumatic dilation cohort will undergo an initial pneumatic dilation with a 30mm Rigiflex (Boston Scientific).

Primary Outcome Measures

Name	Time	Method
Brief esophageal dysphagia questionnaire (BEDQ)	6 months	The BEDQ is a 10-item self-report measure of dysphagia symptoms. The questionnaire is scored on a scale of 0-40. Higher scores indicate greater severity and frequency of dysphagia symptoms.
Eckardt Score	Week 6	The Eckardt score is the grading system most frequently used for the evaluation of symptoms and efficacy of achalasia treatment. 33 It attributes points (0-3 points) to 4 symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss), and its total ranges from 0-12. The higher the score the worse the symptoms.
Number of participants with retained barium column ≥5cm	Week 6	Measured in the timed barium esophagram

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States