Understanding muscle fibrosis in achalasia using new imaging technology

Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders

This study is testing a new imaging method to see how muscle changes in the esophagus relate to achalasia, hoping to find better ways to help patients with this condition.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (other)
• Locations: 2 sites (Atlanta, Georgia and 1 other locations)
• Trial ID: NCT04641702 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the relationship between muscle fibrosis and lower esophageal sphincter (LES) measurements using Functional Lumen Imaging Probe (FLIP) Topography after a pharmacologic challenge. The study aims to enhance the understanding of achalasia, a condition characterized by the inadequate opening of the LES, by exploring both active and passive factors contributing to the disease. Participants will undergo an atropine challenge and esophageal muscle biopsy to gather data on their condition. The goal is to identify earlier intervention opportunities for patients with achalasia.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with achalasia or related esophageal motility disorders who are being evaluated at Emory University facilities.

Not a fit: Patients under 18, pregnant women, prisoners, or those who do not speak English may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more effective interventions for patients with achalasia.

How similar studies have performed: While this approach utilizes novel technology, similar studies have shown promise in understanding esophageal motility disorders.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients, age 18 and above.
2. Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department starting October 1, 2020.
3. Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1)
4. Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1)
5. Undergoing Heller myotomy or per oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2)

Exclusion Criteria:

1. Patients younger than 18 years old
2. Pregnant women
3. Prisoners
4. Non-English speaking - the rationale is that the symptom characterization and outcome data are measured on detailed and fairly lengthy (5-7 pages) questionnaires written in English with some medical terms. These are standardized questionnaires with no short forms available.
5. Cognitively impaired adults unable to provide informed consent
6. Cardiac disease in the form of - arrhythmia requiring ICD or pacemaker, baseline bradycardia with HR \<60 or tachycardia with HR \> 90, congestive heart failure with ejection fraction \<35%, history of myocardial infarction, baseline MAP \<65 or systolic BP \>140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, GFR \<60 \[exclusions for Aim 1 only\]

Where this trial is running

Atlanta, Georgia and 1 other locations

• Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: Anand Jain, MD — Emory University
• Study coordinator: Anand Jain, MD

Conditions: Achalasia, lower esophageal sphincter, Functional Lumen Imaging Probe Topography, anti-fibrosis agents, anti-inflammatory agents