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Correlation of High Resolution Esophageal Manometry With Symptoms

Withdrawn
Conditions
Post Fundoplication
Achalasia
Chest Pain
Dysphagia
GERD
Interventions
Procedure: High Resolution Manometry
Registration Number
NCT01202929
Lead Sponsor
University of Louisville
Brief Summary

High Resolution Manometry is a new technology that utilizes 36 solid state sensors on a thin catheter spaced at 1-cm intervals. One can more effectively measure the pressure of the esophagus. It includes a sophisticated software to display the pressures data as color topography plot using time, length of the esophagus and pressure within the entire esophagus. It is unclear if this technology improvement actually correlates with patient's symptoms.

Detailed Description

In a 2007 retrospective study performed using this technology, 400 subjects referred to the motility lab underwent high resolution manometry (HRM) for complaints of dysphasia, gastroesophageal reflux disease, chest pain and miscellaneous complaints. HRM offered greater detail of individual contracting segments of the esophagus, including the duration of contraction and propagation of individual contractions.

For example, a new subclass of achalasia was defined by HRM. In this classification, achalasia is divided into types 1, 2 and 3. Type 1 corresponds to classic achalasia (complete esophageal motor failure), type 2 is a compression achalasia (simultaneous panesophageal pressurization with aperistalsis), and type 3 is spastic achalasia with aperistalsis (100% spasm). However, it is unclear if this categorization represents a spectrum of disease among patients with achalasia, or it represents distinct subgroups of patients with different symptom presentation and etiology.

This study will attempt to correlate the data from HRM to patient's chief compliants, symptom severity, and clinical presentation.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Subjects who are referred to the motility lab to undergoing esophageal HRM for various clinical indications.
Exclusion Criteria
  • Pregnancy
  • Unable to give consent
  • Less than 18 years old
  • Prisoner

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Type I achalasiaHigh Resolution Manometryclassic achalasia: complete esophageal motor failure
Type III achalasiaHigh Resolution Manometryspastic achalasia with aperistalsis: 100% spasm
Type II achalasiaHigh Resolution Manometrycompression achalasia: simultaneous panesophageal pressurization with aperistalsis
Primary Outcome Measures
NameTimeMethod
Differences and similarities in patients with achalasiaat 24 months

To determine the differences and similarities in the clinical presentation of patients with type 1, 2 and 3 achalasia based on the Chicago classification for HRM

Secondary Outcome Measures
NameTimeMethod
Esophageal dysmotility in patients with postfundoplication compliantsat 24 months

To determine the prevalence of esophageal dysmotility using the Chicago classification based in patients with postfundoplication complaints.

HRM parametersat 24 months

To determine if HRM parameters reflect esophageal physiology between contractile strength of the esophagus and GEJ residual pressure obstructing esophageal flow.

Correlation between HRM and symptomsAt 24 months

To determine if HRM parameters reflect symptom presentations.

Esophageal dysmotility in patients with dysphagia and GERD symptomsat 24 months

To determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.

Trial Locations

Locations (1)

University of Louisville

🇺🇸

Louisville, Kentucky, United States

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