Correlation of High Resolution Esophageal Manometry With Symptoms

Sponsor
University of Louisville (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01202929
Collaborator
(none)
0
1
17.9
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: High Resolution Manometry

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.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Correlation of High Resolution Esophageal Manometry With Symptoms
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Type I achalasia

classic achalasia: complete esophageal motor failure

Procedure: High Resolution Manometry
High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.
Other Names:
  • Manometry
  • Achalasia
  • Type II achalasia

    compression achalasia: simultaneous panesophageal pressurization with aperistalsis

    Procedure: High Resolution Manometry
    High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.
    Other Names:
  • Manometry
  • Achalasia
  • Type III achalasia

    spastic achalasia with aperistalsis: 100% spasm

    Procedure: High Resolution Manometry
    High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.
    Other Names:
  • Manometry
  • Achalasia
  • Outcome Measures

    Primary Outcome Measures

    1. Differences and similarities in patients with achalasia [at 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

    1. Esophageal dysmotility in patients with dysphagia and GERD symptoms [at 24 months]

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

    2. HRM parameters [at 24 months]

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

    3. Esophageal dysmotility in patients with postfundoplication compliants [at 24 months]

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

    4. Correlation between HRM and symptoms [At 24 months]

      To determine if HRM parameters reflect symptom presentations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Louisville Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • University of Louisville

    Investigators

    • Principal Investigator: John Wo, MD, University of Louisville School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Louisville
    ClinicalTrials.gov Identifier:
    NCT01202929
    Other Study ID Numbers:
    • 10.0057
    First Posted:
    Sep 16, 2010
    Last Update Posted:
    Apr 10, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by University of Louisville
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 10, 2017