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

University of Kansas

Status: Withdrawn

Conditions: Esophagogastric Junction Disorder

Treatments: Drug: Botulinum Toxin Type A Injection [Botox]

Study type: Interventional

Funder types: Other

Identifiers

NCT04938102

STUDY00147450

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Abnormal DI - Control

No Intervention group

Description:

Patients' whose distensibility index is measured \<2.8 will receive no intervention.

Abnormal DI - Botox

Active Comparator group

Description:

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).

Treatment:

Drug: Botulinum Toxin Type A Injection [Botox]

Normal DI - Control

No Intervention group

Description:

Patients' whose distensibility index is measured \>2.8 will receive no intervention.