Blown-out myotomy: an adverse event of laparoscopic Heller myotomy and peroral endoscopic myotomy for achalasia.
Joseph R Triggs, Amanda J Krause, Dustin A Carlson...
https://pubmed.ncbi.nlm.nih.gov/32721488/Actively Recruiting
Led by Northwestern University · Updated on 2025-08-11
575
Participants Needed
1
Research Sites
N/A
Total Duration
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
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
J
John E Pandolfino, MD
D
Dustin A Carlson, MD
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Northwestern University
Lead Sponsor
The California Medical Innovations Institute, Inc.
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | FLIP and HRM (Trial Diagnostics) | Clinical Assessment and HRM (Current Care) |
|---|---|---|
| What is it? | Participants undergo FLIP (Functional Lumen Imaging Probe) and high-resolution manometry (HRM), with some receiving prucalopride challenge, to assess esophageal motility and mechanics. The aim is to evaluate FLIP's utility alongside standard HRM and expand diagnostic classification. | Current clinical assessment for esophageal motility disorders uses HRM interpreted by the Chicago Classification (version 4.0), typically after symptom-driven evaluation and basic imaging. |
| Role in trial | Used as investigational tools to study esophageal motility mechanics and refine diagnostic classification. | Standard clinical diagnostic pathway in routine care; not trial-controlled. |
| Primary use | To evaluate esophageal function and mechanical properties, potentially extending diagnostic accuracy and providing additional phenotyping data. | To identify and classify esophageal motility disorders such as achalasia and ineffective esophageal motility using HRM metrics. |
| How is it performed? | FLIP: Endoscopy with FLIP device measures esophageal distensibility; HRM: transnasal catheter measures pressure. In some, prucalopride is administered prior to assessment. All procedures follow protocol-specific sequences and timing. | HRM: Conducted using transnasal catheter; clinical assessment also considers history and other diagnostic imaging when indicated. |
| Evidence status | FLIP has supportive observational and pilot data for identifying esophageal contractility patterns and for characterizing some disorders inadequately detected by HRM alone. Larger systematic evidence is still evolving. | HRM is supported by extensive clinical validation and is the recognized gold standard for diagnosing esophageal motility disorders. Limitations exist in subtle or overlapping phenotypes. |
| Important limitations | FLIP requires sedation during endoscopy and its role in guiding clinical management is not yet universally established. HRM and FLIP interpretation are operator-dependent. Prucalopride challenge is investigational. | HRM can miss certain contractility patterns and may yield inconclusive results in atypical motility disorders. Detailed interpretations require expertise. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/29315993/Northwestern University
Lead Sponsor
The California Medical Innovations Institute, Inc.
Collaborating Sponsor