Correlation of High Resolution Esophageal Manometry With Symptoms - Full Text View

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:

MedlinePlus related topics: Chest Pain Swallowing Disorders

Genetic and Rare Diseases Information Center resources: 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 ] [ 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 23, 2016