Actively Recruiting
Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders
Led by Emory University · Updated on 2025-11-10
80
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating achalasia, a condition where the lower esophageal sphincter (LES) does not open properly. The study aims to better understand muscle fibrosis in relation to LES function using a new technology called Functional Lumen Imaging Probe (FLIP) Topography, which measures LES activity after medication. This research could help identify achalasia earlier and improve treatment options. Participants will undergo an atropine challenge, where they receive an intravenous dose of atropine at 15 mcg/kg. LES measurements will be taken before and two minutes after drug administration using FLIP. Some participants who are having surgery for their esophageal disorder will also have muscle biopsies taken from the LES and distal esophagus to examine collagen content. During the study, researchers will assess LES contraction and relaxation two minutes after drug administration, along with collagen levels in muscle biopsy samples. Participants will have procedures including FLIP measurements and possibly muscle biopsy during surgery. The study is conducted without blinding or placebo and involves monitoring physiological responses to the atropine challenge to better characterize achalasia.
CONDITIONS
Brief Title
Comprehensive Esophageal Diagnostics Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years and above
- Evaluated at Emory Digestive Diseases Clinic, Emory Motility Lab, Emory Endoscopy Unit, or Emory Surgery Department starting October 1, 2020
- Diagnosed with achalasia or an esophageal motility disorder confirmed by FLIP or high-resolution esophageal manometry
- Undergoing a diagnostic FLIP study at Emory University Hospital with anesthesia assistance (for Aim 1)
- Undergoing Heller myotomy or per oral endoscopic myotomy for esophageal motility disorder treatment (for Aim 2)
You will not qualify if you...
- Patients younger than 18 years old
- Pregnant women
- Prisoners
- Non-English speaking due to questionnaire language requirements
- Cognitively impaired adults unable to provide informed consent
- Cardiac conditions including arrhythmia requiring ICD or pacemaker, baseline bradycardia (heart rate <60) or tachycardia (heart rate >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 foley catheterization
- Narrow-angle glaucoma
- Myasthenia gravis
- Glomerular filtration rate (GFR) <60 (exclusions apply for Aim 1 only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline measurements using the Functional Lumen Imaging Probe (FLIP) to assess esophageal motility.
1 visit (in-person)
Duration - Day of atropine challenge and surgery
Participants receive an intravenous atropine challenge followed by repeated FLIP measurements to study esophageal response. For those undergoing surgery, an esophageal muscle biopsy is performed during the standard-of-care Heller myotomy or per-oral endoscopic myotomy.
1 visit (in-person)
Duration - Up to 4 weeks
Participants are monitored after surgery to assess recovery and outcomes related to the biopsy and treatment.
Approximately 2 to 3 post-operative visits
Trial Site Locations
Total: 2 locations
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
A
Anand Jain, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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