Assessing bolus retention in achalasia using high-resolution manometry with impedance: a comparator study with timed barium esophagram.
Yu K Cho, Anna M Lipowska, Frédéric Nicodème...
https://pubmed.ncbi.nlm.nih.gov/24710506Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06883175
Evolution of the Chicago Classification: Bridging Physiology and Mechanics for Esophageal Disorders
Led by Northwestern University · Updated on 2025-08-11
575
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
T
The California Medical Innovations Institute, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying swallowing difficulties, including functional dysphagia, ineffective esophageal motility (IEM), esophagogastric junction outflow obstruction (EGJOO), and achalasia. The trial aims to improve understanding of esophageal wall biomechanics and neuromyogenic function, which are important for normal swallowing but have been underexplored. This research builds on prior work that developed the Chicago Classification to diagnose esophageal motor disorders and seeks to identify new biomechanical markers for better diagnosis and treatment. The study uses advanced diagnostic tests like functional lumen impedance planimetry (FLIP), high-resolution manometry (HRM), and fluoroscopy-based techniques to measure esophageal wall mechanics, pressure, and diameter changes. Participants receive standard care and may undergo treatments such as prucalopride medication or botulinum toxin injections depending on their condition. The research includes assessments before and after interventions like peroral endoscopic myotomy (POEM) and fundoplication surgery to evaluate treatment effects. Participants aged 18 to 85 with swallowing issues or related esophageal conditions will complete questionnaires, imaging, endoscopy, and physiological tests at baseline and follow-up visits up to six months. Researchers will measure outcomes such as esophageal clearance, esophagogastric junction diameter and distensibility, reflux symptoms, and esophageal elasticity. These evaluations will help refine diagnostic models and treatment approaches for esophageal motility disorders.
CONDITIONS
Brief Title
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 85 years old inclusive
- Females of childbearing potential must use highly effective contraception
- Mentally capable of providing informed consent
- Presenting with dysphagia, regurgitation, chest pain, food impaction, or referred for treatment of achalasia, GERD, scleroderma, or endoscopy negative dysphagia
- Able to undergo endoscopy with functional lumen imaging probe (FLIP), 4-dimensional high resolution manometry (4D HRM), and 24-hour pH impedance probe
You will not qualify if you...
- Currently participating in another clinical trial or completed one within the past 8 weeks
- Active severe esophagitis (Grade C or above) unless healed but dysphagia persists
- Mechanical obstruction due to stricture or previous small bowel or colonic obstruction
- Long-segment Barrett's metaplasia
- Unstable medical illness with ongoing treatment (well-controlled hypertension, diabetes, and stable ischemic heart disease allowed)
- Current drug or alcohol abuse or dependency
- Neurologic or cognitive impairment making research participation unsuitable
- Severe mental illness such as uncontrolled major depression with suicidal ideation, active psychosis, or schizophrenia-spectrum disorder
- Pregnant patients
- Bleeding disorders or need for anticoagulation that cannot be stopped for endoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline assessments prior to treatment
Participants undergo standard of care diagnostic testing including endoscopy with FLIP, high resolution manometry (HRM), pH-impedance testing, and questionnaires to assess esophageal function and symptoms.
1 to 2 visits depending on procedures required
Treatment
Duration - 2 weeks for medication or as per clinical treatment schedule for POEM
Participants with specific esophageal conditions receive targeted treatments such as a 2-week course of prucalopride medication or undergo peroral endoscopic myotomy (POEM) as part of their clinical care.
1 to 2 treatment visits plus medication daily as prescribed
Post-treatment Diagnostic Evaluation
Duration - Up to 6 months after treatment
After treatment, participants undergo follow-up diagnostic procedures including FLIP, HRM, esophagram evaluation, and questionnaires to assess treatment effects.
1 to 2 visits up to 6 months post-treatment
Long-term Monitoring
Duration - Up to 6 months post-treatment
Participants are monitored over time to assess long-term outcomes such as esophageal clearance, symptom improvement, and treatment success.
Follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
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Research Team
J
John E Pandolfino, MD
D
Dustin A Carlson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Shashank Acharya, Sourav Halder, Dustin A Carlson...
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A C Barnard, W A Hunt, W P Timlake...
https://pubmed.ncbi.nlm.nih.gov/5972373Intraoperative use of FLIP is associated with clinical success following POEM for achalasia.
Amy L Holmstrom, Ryan A J Campagna, Arturo Cirera...
https://pubmed.ncbi.nlm.nih.gov/32632483Esophagogastric junction distensibility measurements during Heller myotomy and POEM for achalasia predict postoperative symptomatic outcomes.
Ezra N Teitelbaum, Nathaniel J Soper, John E Pandolfino...
https://pubmed.ncbi.nlm.nih.gov/25055891