Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

August 6, 2020 updated by: John M. Wo, Indiana University
Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Gastrointestinal (GI) motility problems are very common in the general population. Dysphagia, difficulty swallowing, is one of the most common issues in gastroenterology. In many patients, esophageal obstruction is not identified despite workup with upper endoscopy or barium swallow x-ray. Patients are often referred to the Motility Laboratory for evaluation of non-obstructive dysphagia. Transnasal esophageal manometry-impedance is a diagnostic test to measure the pressures and coordination of the esophagus during swallowing. The Endolumenal Functional Lumen Imaging Probe (EndoFLIP) is another instrument used to measure the lumen distensibility of the esophagus and pylorus. Both tests are FDA-approved and are currently being used in clinical practice. However, correlation of the results obtained from these tests with clinical syndromes and symptoms is not clearly understood. Furthermore, the relationship between esophageal impedance-manometry and EndoFLIP results has never been defined.

The primary Aim is to develop a registry of patients undergoing esophageal manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study subjects will be recruited from patients who were referred by their physicians to the GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP

Description

Inclusion Criteria:

  • All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP

Exclusion Criteria:

  • Age <18 yrs old
  • Unable to communicate verbally with the staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dysphagia
Patients with Esophageal dysphagia
Transnasal Esophageal manometry and Endoflip Balloon distensibility
Other Names:
  • Endoflip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoflip parameters for gastroparesis
Time Frame: 5 years
Compare the distensibility index (mm2/mmHg) of the pylorus at 50 ml distension in patients with postsurgical gastroparesis and compare to patients with idiopathic and diabetic gastroparesis.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between endoflip parameters and gastric scintigraphy
Time Frame: 5 years
Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis
5 years
Correlation between endoflip parameters and symptom severity
Time Frame: 5 years
Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John M Wo, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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