Correlation of High Resolution Esophageal Manometry With Symptoms

This study has been withdrawn prior to enrollment.

(Principal investigator has left the Institution)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01202929

First Posted: September 16, 2010

Last Update Posted: April 10, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

University of Louisville

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:

Genetic and Rare Diseases Information Center resources: Idiopathic Achalasia Cardiospasm

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 ]
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 ]
To determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.
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.
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.
Correlation between HRM and symptoms [ Time Frame: At 24 months ]
To determine if HRM parameters reflect symptom presentations.


Enrollment:	0
Study Start Date:	February 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (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

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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

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


Responsible Party:	University of Louisville
ClinicalTrials.gov Identifier:	NCT01202929 History of Changes
Other Study ID Numbers:	10.0057
First Submitted:	September 14, 2010
First Posted:	September 16, 2010
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 Chest Pain Deglutition Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms	Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases Esophageal Motility Disorders

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