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Correlation of High Resolution Esophageal Manometry With Symptoms

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ClinicalTrials.gov Identifier: NCT01202929
Recruitment Status : Withdrawn (Principal investigator has left the Institution)
First Posted : September 16, 2010
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Achalasia Dysphagia GERD Chest Pain Post Fundoplication 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
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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 : February 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Differences and similarities in patients with achalasia [ Time Frame: 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 [ Time Frame: at 24 months ]
    To determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.

  2. HRM parameters [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At 24 months ]
    To determine if HRM parameters reflect symptom presentations.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from patients referred to the University Medical Associates motility lab for high resolution manometry
Criteria

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202929


Locations
United States, Kentucky
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
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01202929     History of Changes
Other Study ID Numbers: 10.0057
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by University of Louisville:
High Resolution Manometry
achalasia
dysphagia
 GERD
chest pain
Post fundoplication

Additional relevant MeSH terms:
Esophageal Achalasia
Deglutition Disorders
Chest Pain
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
 Otorhinolaryngologic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Esophageal Motility Disorders