Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT04641702

Conditions

Achalasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atropine challenge

Esophageal muscle biopsy

Study Details

Brief summary:

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.

Conditions

Achalasia

Study ID

NCT04641702

Start date

Mar 17, 2021

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 \[exclusions for Aim 1 only\]

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pharmacologic challenge

Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)

Interventions

Atropine challenge

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

Esophageal muscle biopsy. During standard-of-care Heller myotomy or per-oral endoscopic myotomy, 5mm of lower esophageal sphincter and distal esophageal circular muscle will be collected via biopsy forceps.

Primary outcome measure

  • Degree of lower esophageal sphincter contraction and relaxation [ Time Frame: Two minutes after the study drugs administration ]
  • The collagen content in muscle biopsy specimens [ Time Frame: Two minutes after the study drugs administration ]

Central Contacts and Locations

Central contacts

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

More Information

Sponsor

Emory University

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • lower esophageal sphincter
  • Functional Lumen Imaging Probe Topography
  • anti-fibrosis agents
  • anti-inflammatory agents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-11-10.