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

NCT ID: NCT04938102

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2024-10-11

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.

Conditions

Esophagogastric Junction Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Abnormal DI - Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A Injection [Botox]

Intervention Type: DRUG

Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).

Normal DI - Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Botulinum Toxin Type A Injection [Botox]

Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Reza Hejazi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Hejazi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Other Identifiers

STUDY00147450

Identifier Type: -

Identifier Source: org_study_id