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

Esophagogastric Junction Disorder Clinical Trial

— EndoFLIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04938102
• Other study ID #: STUDY00147450
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: July 2022

Study information

• Verified date: June 2021
• Source: University of Kansas Medical Center
• Contact: Tabitha M Norbury
• Phone: 417-684-7524
• Email: tnorbury[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagogastric Junction Disorder

Intervention

Drug:
• Botulinum Toxin Type A Injection [Botox]
Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Resolution	The primary endpoint is the proportion of patients with complete symptom resolution at 12 weeks (Eckardt score < 3) post procedure in each group.	12 weeks.
Secondary	Percent change in symptom score	The secondary endpoint is the percent change in symptom score at 12 weeks in each group.	12 weeks.
Secondary	Mean symptom scores	The secondary endpoint is the change in mean symptom score in each group at 12 weeks.	12 weeks.