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

NCT04938102 | Withdrawn

• 1 other identifier: STUDY00147450
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophagogastric Junction Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent change in symptom score

  12 weeks.

• Mean symptom scores

  12 weeks.

Study Arms (3)

Abnormal DI - Control

NO INTERVENTION

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

Abnormal DI - Botox

ACTIVE COMPARATOR

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]

Normal DI - Control

NO INTERVENTION

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

Interventions

Botulinum Toxin Type A Injection [Botox] DRUG

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

Abnormal DI - Botox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with esophagogastric junction outflow obstruction by high resolution manometry

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Reza Hejazi, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 24, 2021
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: October 11, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share