Comprehensive Esophageal Diagnostics Study

Launched by EMORY UNIVERSITY · Nov 18, 2020

Keywords

ClinConnect Summary

The Comprehensive Esophageal Diagnostics Study is a clinical trial aimed at understanding a condition called achalasia, which affects how food moves down the esophagus. This study will look at the muscles in the lower part of the esophagus and how they respond to a special test using new technology called Functional Lumen Imaging Probe (FLIP). By learning more about this condition, researchers hope to find ways to diagnose and treat it earlier, which could improve outcomes for patients.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with achalasia or a related esophageal motility disorder. They should have been evaluated at specific Emory facilities between October 2020 and September 2024 and will need to undergo a FLIP study or a surgical procedure for their condition. Participants can expect to undergo tests that will help doctors gather important information about their esophagus. It's also important to note that certain individuals, like those with specific health issues or cognitive impairments, may not be eligible for the study.

Gender

ALL

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 \[exclusions for Aim 1 only\]