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Comprehensive Esophageal Diagnostics Study

Primary Purpose

Achalasia

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Atropine challenge

Esophageal muscle biopsy

About this trial

This is an interventional treatment trial for Achalasia focused on measuring lower esophageal sphincter, Functional Lumen Imaging Probe Topography, anti-fibrosis agents, anti-inflammatory agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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]

Sites / Locations

Emory University HospitalRecruiting
Emory Saint Joseph's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacologic challenge

Arm Description

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

Outcomes

Primary Outcome Measures

Degree of lower esophageal sphincter contraction and relaxation

Degree of lower esophageal sphincter contraction and relaxation will be measured

The collagen content in muscle biopsy specimens

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04641702

First Posted

November 18, 2020

Last Updated

March 14, 2023

Sponsor

Emory University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04641702

Brief Title

Comprehensive Esophageal Diagnostics Study

Official Title

Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 17, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

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

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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.

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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achalasia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pharmacologic challenge

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Atropine challenge

Intervention Description

Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated.

Intervention Type

Procedure

Intervention Name(s)

Esophageal muscle biopsy

Intervention Description

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 Information:

Title

Degree of lower esophageal sphincter contraction and relaxation

Description

Degree of lower esophageal sphincter contraction and relaxation will be measured

Time Frame

Two minutes after the study drugs administration

Title

The collagen content in muscle biopsy specimens

Description

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

Time Frame

Two minutes after the study drugs administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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]

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anand Jain, MD

Phone

404-778-3184

anand.jain@emory.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anand Jain, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Recruiting

Facility Name

Emory Saint Joseph's Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Esophageal function testing data, symptom questionnaire data, treatments performed, and biospecimen analysis results will be shared.

IPD Sharing Time Frame

Estimated January 2024.

IPD Sharing Access Criteria

Collaborators with whom the study team has Data Use Agreements in Place will have access through secure electronic means.

Learn more about this trial

Comprehensive Esophageal Diagnostics Study

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