Understanding muscle fibrosis in achalasia using new imaging technology

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the relationship between muscle fibrosis and lower esophageal sphincter (LES) measurements using Functional Lumen Imaging Probe (FLIP) Topography after a pharmacologic challenge. The study aims to enhance the understanding of achalasia, a condition characterized by the inadequate opening of the LES, by exploring both active and passive factors contributing to the disease. Participants will undergo an atropine challenge and esophageal muscle biopsy to gather data on their condition. The goal is to identify earlier intervention opportunities for patients with achalasia.

Why it matters

Who can join: the full rules

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 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)
* 8 healthy control esophageal samples will be obtained from the NDRI donor program for Aim 2.

Exclusion Criteria:

* 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
* Cardiac disease in the form of - arrhythmia requiring intracardiac defibrillator (ICD) or pacemaker, baseline bradycardia with HR \<60 or tachycardia with a heart rate (HR) \> 90, congestive heart failure with ejection fraction \<35%, history of myocardial infarction, baseline mean arterial pressure (MAP) \<65 or systolic blood pressure (BP) \>140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, glomerular filtration rate (GFR) \<60 \[exclusions for Aim 1 only\]

Where it's running

• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Emory Saint Joseph's Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Anand Jain, MD — Emory University
• Study coordinator: Anand Jain, MD
• Email: anand.jain@emory.edu
• Phone: 404-778-3184

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Full-thickness vs progressive myotomy in POEM for achalasia

  This trial tests whether a full-thickness myotomy during POEM works better than a partial, progressive approach for people with achalasia, to see which method better relieves symptoms with fewer side effects.

  Recruiting at 2 sites Phase 2 Cairo University · Cairo and 1 other locations · NCT07875686

• Impact of Patient Position on EndoFLIP Measurements in Kids and Young Adults

  This study tests whether EndoFLIP measurements differ when patients are in the supine versus left-side position during the procedure.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT07780981

• A registry for adults with esophageal movement and reflux problems.

  This project will collect esophageal function tests (manometry, pH-impedance, FLIP) and clinical data from adults with reflux or swallowing symptoms to see if combining these results helps guide diagnosis and long-term care.

  Recruiting IRCCS San Raffaele · Milan, Lombardy · NCT07506746

• Speedboat UltraSlim™ for POEM in adults with achalasia and other esophageal motility disorders.

  This registry will see if using the Speedboat UltraSlim™ device for POEM is safe and effective for adults with achalasia or other esophageal motility disorders.

  Recruiting Baylor College of Medicine · Houston, Texas · NCT07496840

• Using the SpydrBlade Flex device during POEM for achalasia and EGJ outflow obstruction

  This will test whether using the SpydrBlade Flex device during POEM is safe and effective for adults with achalasia or EGJ outflow obstruction.

  Recruiting at 2 sites Chinese University of Hong Kong · Guayaquil and 1 other locations · NCT07406945

• Indocyanine green fluorescence during laparoscopic Heller–Dor for achalasia

  This study will try using indocyanine green dye during laparoscopic Heller‑Dor in adults with type I or II achalasia to find mucosal leaks during surgery and help guide repairs.

  Recruiting Federico II University · Naples · NCT07181070

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.