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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04641702
Other study ID # STUDY00001665
Secondary ID 1K23DK131317-01A
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 17, 2021
Est. completion date December 2024

Study information

Verified date April 2024
Source Emory University
Contact Anand Jain, MD
Phone 404-778-3184
Email anand.jain@emory.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 from October 1, 2020, to September 30, 2024. 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) of questionnaires written in English with some medical terms. These are standardized questionnaires and do not have 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


Related Conditions & MeSH terms


Intervention

Drug:
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.
Procedure:
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.

Locations

Country Name City State
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Atlanta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of lower esophageal sphincter contraction and relaxation Degree of lower esophageal sphincter contraction and relaxation will be measured Two minutes after the study drugs administration
Primary The collagen content in muscle biopsy specimens The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining. Two minutes after the study drugs administration
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