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Correlation of High Resolution Esophageal Manometry With Symptoms

Correlation of High Resolution Esophageal Manometry With Symptoms

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01202929
Enrollment
0
Registered
2010-09-16
Start date
2010-02-28
Completion date
2011-08-31
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, Dysphagia, GERD, Chest Pain, Post Fundoplication

Keywords

High Resolution Manometry, achalasia, dysphagia, GERD, chest pain, Post fundoplication

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.

Interventions

High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.

Sponsors

University of Louisville
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences and similarities in patients with achalasiaat 24 monthsTo 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

MeasureTime frameDescription
Esophageal dysmotility in patients with dysphagia and GERD symptomsat 24 monthsTo determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.
HRM parametersat 24 monthsTo 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 compliantsat 24 monthsTo determine the prevalence of esophageal dysmotility using the Chicago classification based in patients with postfundoplication complaints.
Correlation between HRM and symptomsAt 24 monthsTo determine if HRM parameters reflect symptom presentations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026