Comprehensive Esophageal Diagnostics Study

NCT04641702 | Recruiting Phase 4 DMC FDA Drug

• 4 other identifiers: STUDY000016651K23DK131317-01A1R03DK1459622025P013181
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Achalasia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Pharmacologic challenge

EXPERIMENTAL

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

Drug: Atropine challenge

Esophageal muscle biopsy

OTHER

Patients with a diagnosis of an esophageal motility disorder who are undergoing Heller myotomy, per-oral endoscopic myotomy, or esophagectomy for treatment of their esophageal motility disorder.

Procedure: Esophageal muscle biopsy

Normal esophageal tissues

NO INTERVENTION

Normal esophageal tissues will be obtained from the National Disease Research Interchange (NDRI) donor program to perform muscle biopsy experiments.

Interventions

Atropine challenge DRUG

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

Pharmacologic challenge

Esophageal muscle biopsy PROCEDURE

During standard-of-care Heller myotomy, per-oral endoscopic myotomy, or esophagectomy, lower esophageal sphincter and distal esophageal circular muscle samples will be taken with biopsy forceps. 2-3 samples, approximately 2-3 mm each, will be collected.

Esophageal muscle biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 starting October 1, 2020.
• 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 the treatment of their esophageal motility disorder (for Aim 2)
• healthy control esophageal samples will be obtained from the NDRI donor program for Aim 2.

You may not qualify if:

• Patients younger than 18 years old
• Pregnant women
• Prisoners
• Non-English-speaking patients - 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.
• Cognitively impaired adults unable to provide informed consent

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anand Jain, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anand Jain, MD

CONTACT

404-778-3184; anand.jain@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants may consent to Aim 1(pharmacologic challenge), Aim 2 (if they undergo a future myotomy), or both aims. After completion of Aim 1 enrollment, participants who are scheduled to undergo Heller myotomy, per-oral endoscopic myotomy (POEM), or esophagectomy for treatment of their esophageal motility disorder may participate in Aim 2 only.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: March 17, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Collaborators with whom the study team has Data Use Agreements in Place will have access through secure electronic means.

Locations

US (2)