Clinical trial NCT04641702: Comprehensive Esophageal Diagnostics Study
Official title: Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Achalasia
Keywords: lower esophageal sphincter
Functional Lumen Imaging Probe Topography
anti-fibrosis agents
anti-inflammatory agents
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-11-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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 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 \[exclusions for Aim 1 only\]

Primary outcomes:
measure: Degree of lower esophageal sphincter contraction and relaxation
timeFrame: Two minutes after the study drugs administration
measure: The collagen content in muscle biopsy specimens
timeFrame: Two minutes after the study drugs administration
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Anand Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: