Comprehensive Esophageal Diagnostics Study

Achalasia Clinical Trial

Official title:

Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641702
• Other study ID #: STUDY00001665
• Secondary ID: 1K23DK131317-01A
• Status: Recruiting
• Phase: Phase 4
• 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
• 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]

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

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