Comprehensive Esophageal Diagnostics Study

NCT ID: NCT04641702

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2026-12-31

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.

Conditions

Achalasia

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pharmacologic challenge

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

Group Type: EXPERIMENTAL

Atropine challenge

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

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.

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Anand Jain

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anand Jain, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anand Jain, MD

Role: CONTACT

Phone: 404-778-3184

Email: anand.jain@emory.edu

Other Identifiers

1K23DK131317-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P013181

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00001665

Identifier Type: -

Identifier Source: org_study_id