Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Manometry.
- Who it may be relevant to
- Registry conditions: Dysphagia, Esophageal. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis
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
Interventions
- Diagnostic test Manometry
Transnasal Esophageal manometry and Endoflip Balloon distensibility
Primary outcome measures
- Endoflip parameters for gastroparesis [Time frame: 5 years]
Secondary outcome measures (2)
- Correlation between endoflip parameters and gastric scintigraphy [Time frame: 5 years]
- Correlation between endoflip parameters and symptom severity [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Indiana University Health University Hospital — Indianapolis
Identifiers
NCT: NCT04503785 · 1701721848