Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

Dysphagia, Esophageal Clinical Trial

Official title:

Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503785
• Other study ID #: 1701721848
• Status: Recruiting
• Start date: January 17, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2020
• Source: Indiana University
• Contact: Basil Kahwash, MD
• Email: bkahwash[@]iu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Esophageal

Intervention

Diagnostic Test:
• Manometry
Transnasal Esophageal manometry and Endoflip Balloon distensibility

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoflip parameters for gastroparesis	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	Correlation between endoflip parameters and gastric scintigraphy	Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis	5 years
Secondary	Correlation between endoflip parameters and symptom severity	Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)	5 years