Clinical trial NCT01202929: Correlation of High Resolution Esophageal Manometry With Symptoms
Official title: Correlation of High Resolution Esophageal Manometry With Symptoms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Achalasia
Dysphagia
GERD
Chest Pain
Post Fundoplication
Keywords: High Resolution Manometry
achalasia
dysphagia
GERD
chest pain
Post fundoplication
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Differences and similarities in patients with achalasia
timeFrame: at 24 months
Secondary outcomes:
measure: Esophageal dysmotility in patients with dysphagia and GERD symptoms
timeFrame: at 24 months
measure: HRM parameters
timeFrame: at 24 months
measure: Esophageal dysmotility in patients with postfundoplication compliants
timeFrame: at 24 months
measure: Correlation between HRM and symptoms
timeFrame: At 24 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville School of Medicine
name: John Wo, MD
role: PRINCIPAL_INVESTIGATOR
References: