Correlation of High Resolution Esophageal Manometry With Symptoms

April 6, 2017 updated by: University of Louisville
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 24 months
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.
at 24 months
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.
at 24 months
Correlation between HRM and symptoms
Time Frame: At 24 months
To determine if HRM parameters reflect symptom presentations.
At 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.0057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chest Pain

Clinical Trials on High Resolution Manometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe