NCT04096703

Idiopathic Esophagogastric Junction Outflow Obstruction

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagogastric Junction Disorder

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2019-09-20
• Last updated: 2022-03-04

Locations

1 site across 1 country: United States