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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction

Conditions
-----------------
Esophagogastric Junction Disorder

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A Injection [Botox]


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Abnormal DI - Control<br>Patients' whose distensibility index is measured <2.8 will receive no intervention. | |
| Active Comparator: Abnormal DI - Botox<br>Patients' whose distensibility index is measured <2.8 will be injected with 100 units of botulinum toxin in the lower esophageal sphincter (25 units in each quadrant). | Drug: Botulinum Toxin Type A Injection [Botox]<br>* Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).<br>|
| No Intervention: Normal DI - Control<br>Patients' whose distensibility index is measured >2.8 will receive no intervention. | |
| Active Comparator: Normal DI - Botox<br>Patients' whose distensibility index is measured >2.8 will be injected with 100 units of botulinum toxin in the lower esophageal sphincter (25 units in each quadrant). | Drug: Botulinum Toxin Type A Injection [Botox]<br>* Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in symptom score | The secondary endpoint is the percent change in symptom score at 12 weeks in each group. | 12 weeks. | 
| Mean symptom scores | The secondary endpoint is the change in mean symptom score in each group at 12 weeks. | 12 weeks. |