Comprehensive Esophageal Diagnostics Study

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04641702

Collaborator

(none)

Enrollment

Location

Arm

31.5

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Drug: Atropine challenge Procedure: Esophageal muscle biopsy	Phase 4

Detailed 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients will have the option of consenting for Aim 1(pharmacologic challenge ), Aim 2 (in the event they go for future myotomy) or both if they choose to be included in the study.Patients will have the option of consenting for Aim 1(pharmacologic challenge ), Aim 2 (in the event they go for future myotomy) or both if they choose to be included in the study.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders

Actual Study Start Date :

Mar 17, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmacologic challenge Measurement of esophageal response toatropine using functional lumen imaging probe (FLIP)	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.

Arm

Intervention/Treatment

Experimental: Pharmacologic challenge

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

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.

Outcome Measures

Primary Outcome Measures

Degree of lower esophageal sphincter contraction and relaxation [Two minutes after the study drugs administration]
Degree of lower esophageal sphincter contraction and relaxation will be measured
The collagen content in muscle biopsy specimens [Two minutes after the study drugs administration]
The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 from October 1, 2020 to September 30, 2023.
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 treatment of their esophageal motility disorder (for Aim 2)

Exclusion Criteria:

Patients younger than 18 years old
Pregnant women
Prisoners
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.
Cognitively impaired adults unable to provide informed consent
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 use of foley catheterization (including intermittent use), narrow angle glaucoma, myasthenia gravis, GFR <60 [exclusions for Aim 1 only]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator: Anand Jain, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anand Jain, Principal Investigator, Emory University

ClinicalTrials.gov Identifier:

NCT04641702

Other Study ID Numbers:

STUDY00001665

First Posted:

Nov 24, 2020

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Anand Jain, Principal Investigator, Emory University

lower esophageal sphincter

Functional Lumen Imaging Probe Topography

anti-fibrosis agents

anti-inflammatory agents

Additional relevant MeSH terms:

Esophageal Achalasia

Atropine

Study Results

No Results Posted as of Mar 10, 2022