Esophagogastric Junction Disorder
Conditions
Keywords
Idiopathic Esophagogastric Junction Outflow Obstruction, Esophageal Sphincter Function, Esophagogastric Junction, Pneumatic Dilation
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.
Interventions
PROCEDUREPneumatic dilation
The patients randomized to the pneumatic dilation cohort will undergo an initial pneumatic dilation with a 30mm Rigiflex (Boston Scientific). If the Eckardt score four weeks after initial dilation is \> 4, then the patient will be scheduled for a second dilation with a 35mm Rigiflex balloon (Boston Scientific).
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief esophageal dysphagia questionnaire (BEDQ) | Week 0 | 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 0 | 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 |
Countries
United States
Outcome results
None listed