Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

Recruiting

• Conditions: Dysphagia, Esophageal
• Interventions: Diagnostic Test: Manometry

• Registration Number: NCT04503785
• Lead Sponsor: Indiana University

Brief Summary

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-17
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dysphagia	Manometry	Patients with Esophageal dysphagia

Primary Outcome Measures

Name	Time	Method
Endoflip parameters for gastroparesis	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States