Comprehensive Esophageal Diagnostics Study
ConditionAchalasia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Atropine challenge
DrugAtropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated.
Esophageal muscle biopsy
Procedure/SurgeryDuring 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.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Pharmacologic challengeExperimental treatment 1 intervention
Group B: Esophageal muscle biopsyOther 1 intervention
Group C: Normal esophageal tissuesNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Degree of lower esophageal sphincter contraction and relaxation
Degree of lower esophageal sphincter contraction and relaxation will be measured
Time frame
Two minutes after the study drugs administration2
The collagen content in muscle biopsy specimens
The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining.
Time frame
Two minutes after the study drugs administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov