Correlation of High Resolution Esophageal Manometry With Symptoms
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ClinicalTrials.gov Identifier: NCT01202929 |
Recruitment Status
:
Withdrawn
(Principal investigator has left the Institution)
First Posted
: September 16, 2010
Last Update Posted
: April 10, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Achalasia Dysphagia GERD Chest Pain Post Fundoplication | Procedure: High Resolution Manometry |
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.
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Correlation of High Resolution Esophageal Manometry With Symptoms |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |
Group/Cohort | Intervention/treatment |
---|---|
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:
|
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:
|
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:
|
- 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
- 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.

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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 |
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

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
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | John Wo, MD | University of Louisville School of Medicine |
Responsible Party: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT01202929 History of Changes |
Other Study ID Numbers: |
10.0057 |
First Posted: | September 16, 2010 Key Record Dates |
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 Deglutition Disorders Chest Pain Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases |
Otorhinolaryngologic Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Esophageal Motility Disorders |