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

Esophagogastric Junction Disorder Clinical Trial

Official title: Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding.

1. Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017. ;

Related Conditions & MeSH terms

• Esophagogastric Junction Disorder

• NCT number: NCT04938102
• Study type: Interventional
• Source: University of Kansas Medical Center
• Contact: Tabitha M Norbury
• Phone: 417-684-7524
• Email: tnorbury@kumc.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Completion date: July 2022