Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be a larger difference in proportion of symptom resolution between the control and treatments groups in the abnormal DI category than in the normal DI category.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Kansas Medical Center
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• diagnosed with esophagogastric junction outflow obstruction by high resolution manometry

Exclusion Criteria:

• previous upper gastrointestinal surgery

• significant medical co-morbidities

• eosinophilic esophagitis

• severe reflux esophagitis (LA-classification C or D)

• large hiatal hernia

• patients experiencing significant weight loss suspicious for malignancy

• Vulnerable populations such as cognitively or decisionally impaired individuals, children, pregnant women, prisoners, and students or employees of the University of Kansas Health System or Medical Center