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

Not Applicable

Withdrawn

• Conditions: Esophagogastric Junction Disorder
• Interventions: Drug: Botulinum Toxin Type A Injection [Botox]

• Registration Number: NCT04938102
• Lead Sponsor: University of Kansas Medical Center

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 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.

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 Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-24
• Study Start: 2022-07
• Primary Completion: 2023-07
• Status Verified: 2024-10
• Study Completion: 2024-10-11
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abnormal DI - Botox	Botulinum Toxin Type A Injection [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).

Primary Outcome Measures

Name	Time	Method
Symptom Resolution	12 weeks.	The primary endpoint is the proportion of patients with complete symptom resolution at 12 weeks (Eckardt score \< 3) post procedure in each group.

Secondary Outcome Measures

Name	Time	Method
Mean symptom scores	12 weeks.	The secondary endpoint is the change in mean symptom score in each group at 12 weeks.
Percent change in symptom score	12 weeks.	The secondary endpoint is the percent change in symptom score at 12 weeks in each group.