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Correlation of High Resolution Esophageal Manometry With Symptoms
This study has been withdrawn prior to enrollment.
(Principal investigator has left the Institution)
Sponsor:
University of Louisville
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01202929
First received: September 14, 2010
Last updated: April 6, 2017
Last verified: April 2017
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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:
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:
|
|
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:
|
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) |
| 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
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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
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: | University of Louisville |
| ClinicalTrials.gov Identifier: | NCT01202929 History of Changes |
| Other Study ID Numbers: |
10.0057 |
| Study First Received: | September 14, 2010 |
| Last Updated: | April 6, 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 |
ClinicalTrials.gov processed this record on June 26, 2017