Text Size

Correlation of High Resolution Esophageal Manometry With Symptoms

This study has been terminated.
(Principal investigator has left the Institution)
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT01202929
First received: September 14, 2010
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Achalasia
Dysphagia
GERD
Chest Pain
Post Fundoplication
 Procedure: High Resolution Manometry

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Correlation of High Resolution Esophageal Manometry With Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Differences and similarities in patients with achalasia [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    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:
  • Esophageal dysmotility in patients with dysphagia and GERD symptoms [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    To determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.

  • HRM parameters [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    To determine if HRM parameters reflect esophageal physiology between contractile strength of the esophagus and GEJ residual pressure obstructing esophageal flow.

  • Esophageal dysmotility in patients with postfundoplication compliants [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    To determine the prevalence of esophageal dysmotility using the Chicago classification based in patients with postfundoplication complaints.

  • Correlation between HRM and symptoms [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
    To determine if HRM parameters reflect symptom presentations.


Estimated Enrollment: 300
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: John Wo, M.D., University of Louisville School of Medicine
ClinicalTrials.gov Identifier: NCT01202929     History of Changes
Other Study ID Numbers: 10.0057
Study First Received: September 14, 2010
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013