Idiopathic Esophagogastric Junction Outflow Obstruction

Esophagogastric Junction Disorder Clinical Trial

Official title:

Characterization of Lower Esophageal Sphincter Function in Idiopathic Esophagogastric Junction Outflow Obstruction and Clinical Response to Pneumatic Dilation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04096703
• Other study ID #: IRB00060689
• Status: Withdrawn
• Phase: N/A
• Start date: October 2021
• Est. completion date: February 2024

Study information

• Verified date: November 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagogastric Junction Disorder

Intervention

Procedure:
• Pneumatic 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).

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief esophageal dysphagia questionnaire (BEDQ)	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.	Week 0
Primary	Brief esophageal dysphagia questionnaire (BEDQ)	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.	6 months
Primary	Eckardt Score	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.	Week 0
Primary	Eckardt Score	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.	Week 4
Primary	Eckardt Score	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.	Week 6
Primary	Number of participants with retained barium column =5cm	Measured in the timed barium esophagram	Week 6