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NCT Number: NCT04641702

Comprehensive Esophageal Diagnostics Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

About this study

Achalasia is a disease characterized by inadequate opening of the lower esophageal sphincter. Achalasia is presumed to be due to neuronal dysfunction (active), however there are other variables such as muscle layer fibrosis (passive) that may contribute, particularly in milder or earlier achalasia variants. A new technology, impedance planimetry, may be able to measure active vs passive features of the lower esophageal sphincter (LES).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]

Treatment and study plan

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.

Primary outcomes

  1. Degree of lower esophageal sphincter contraction and relaxation

    Time frame: Two minutes after the study drugs administration

    Degree of lower esophageal sphincter contraction and relaxation will be measured

  2. The collagen content in muscle biopsy specimens

    Time frame: Two minutes after the study drugs administration

    The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Nov 24, 2020
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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