RECRUITING Phase 4 ClinicalTrials.gov

Comprehensive Esophageal Diagnostics Study

Sponsor: Emory University • ClinicalTrials.gov ID: NCT04641702

Registry updated: 2026-09-16

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Description

The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.

Interventions

Atropine challenge (Drug)
Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated.
Esophageal muscle biopsy (Procedure)
During standard-of-care Heller myotomy, per-oral endoscopic myotomy, or esophagectomy, lower esophageal sphincter and distal esophageal circular muscle samples will be taken with biopsy forceps. 2-3 samples, approximately 2-3 mm each, will be collected.

Eligibility criteria

Inclusion Criteria: * Male or female patients, age 18 and above. * Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department starting October 1, 2020. * 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) * Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1) * Undergoing Heller myotomy or per-oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2) * 8 healthy control esophageal samples will be obtained from the NDRI donor program for Aim 2. Exclusion Criteria: * Patients younger than 18 years old * Pregnant women * Prisoners * Non-English-speaking patients - 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. * Cognitively impaired adults unable to provide informed consent * Cardiac disease in the form of - arrhythmia requiring intracardiac defibrillator (ICD) or pacemaker, baseline bradycardia with HR \<60 or tachycardia with a heart rate (HR) \> 90, congestive heart failure with ejection fraction \<35%, history of myocardial infarction, baseline mean arterial pressure (MAP) \<65 or systolic blood pressure (BP) \>140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, glomerular filtration rate (GFR) \<60 \[exclusions for Aim 1 only\]

Conditions

Achalasia

Locations

Emory University Hospital — Atlanta, Georgia, United States
Emory Saint Joseph's Hospital — Atlanta, Georgia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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