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

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 greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.

Study Overview

• Status: Withdrawn
• Conditions: Esophagogastric Junction Disorder
• Intervention / Treatment: Drug: Botulinum Toxin Type A Injection [Botox]

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Abnormal DI - Control; Patients' whose distensibility index is measured <2.8 will receive no intervention.
Active Comparator: Abnormal DI - Botox; 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]; Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).
No Intervention: Normal DI - Control; Patients' whose distensibility index is measured >2.8 will receive no intervention.

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.

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Reza Hejazi, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2022
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Actual): October 11, 2024

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: STUDY00147450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No