Correlation of High Resolution Esophageal Manometry With Symptoms

Dysphagia Clinical Trial

Official title:

Correlation of High Resolution Esophageal Manometry With Symptoms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01202929
• Other study ID #: 10.0057
• Status: Withdrawn
• Phase: N/A
• First received: September 14, 2010
• Last updated: April 6, 2017
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Chest Pain
• Deglutition Disorders
• Dysphagia
• Esophageal Achalasia
• GERD
• Post Fundoplication

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences and similarities in patients with achalasia	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	at 24 months
Secondary	Esophageal dysmotility in patients with dysphagia and GERD symptoms	To determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.	at 24 months
Secondary	HRM parameters	To determine if HRM parameters reflect esophageal physiology between contractile strength of the esophagus and GEJ residual pressure obstructing esophageal flow.	at 24 months
Secondary	Esophageal dysmotility in patients with postfundoplication compliants	To determine the prevalence of esophageal dysmotility using the Chicago classification based in patients with postfundoplication complaints.	at 24 months
Secondary	Correlation between HRM and symptoms	To determine if HRM parameters reflect symptom presentations.	At 24 months