Prevalence of IEM Among Upper GIT Symptoms

June 12, 2023 updated by: Aya Ahmed Otify, Assiut University

Prevalence of Ineffective Esophageal Motility Among Upper Gastrointestinal Symptoms

  • detect the prevalence of IEM among upper git symptom .
  • clarify the role of HRM in diagnosis of refractory upper GIT symptoms.

Study Overview

Status

Not yet recruiting

Detailed Description

Ineffective esophageal motility (IEM) is characterized by both failed peristalsis and frequent swallows with breaks in the middle/distal peristaltic wave and it may result in symptoms reflecting poor esophageal emptying. As such, IEM may play a role in gastroesophageal reflux disease (GERD) and nonobstructive dysphagia.1 The definition of IEM has evolved after the introduction of high-resolution manometry (HRM), esophageal pressur topography (EPT), and the Chicago Classification of esophageal motility, that-in its second version-defined IEM as weak peristalsis, small (2-5 cm) and large (over 5 cm) peristaltic defects, or frequent (>30%) failed peristalsis. 2 More recently however, the updated third version of the Chicago Classification eliminated small and large breaks from the list of criteria and defined ineffective swallows by a DCI < 45 mmHg.s.cm with ≥50% ineffective swallows constituting IEM, thus eliminating the distinction between failed swallows and weak swallows.3 IEM, as well as fragmented peristalsis, is considered as minor disorders of peristalsis and their clinical significance remains debatable. IEM is the most common abnormality observed in routine esophageal manometry, with an estimated prevalence of 20%-30% reported a prevalence of 51% in patients with esophageal dysphagia. Before 2008 a threshold of 30% was used, but a threshold of 50% correlates better with dysphagia and heartburn.

High-resolution manometry (HRM) provides an improved and more detailed information on esophageal motility when compared to conventional manometry, and today is considered the best test for diagnosis of motility disorders.

Study Type

Observational

Enrollment (Estimated)

50

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 Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patient bove the age of 18 years old presented with upper git symptoms

Description

Inclusion Criteria:

  1. patient bove the age of 18 years old
  2. All patient presented with upper git symptoms

Exclusion Criteria:

1 - Patients <18 years old 2- patient with known obstructive esophageal disease by endoscopy (i.e. cancer, Stricture) 3- systemic illnesses, scleroderma 4- esophagogastric junction (EGJ) outflow obstruction (mean integrated relaxation pressure ≥15 mmHg).

5- achalasia, 6-Patient who had previouslyundergone esophageal surgery (i.e. antireflux surgery or myotomy) or endoscopic intervention (i.e. transoral fundoplication) were excluded.

7- Patient with atypical (ENT or respiratory) symptoms only . 8-Patient with oropharyngeal dysphagia without associated esophageal symptoms .

9-patient receiving chemotherapy or radiotherapy 10-patient with thyroid disfunction 11- patient with pulber palsy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect the prevalence of IEM among upper git symptom
Time Frame: Basline
detect the prevalence of IEM among upper git symptom
Basline
clarify the role of HRM in diagnosis of refractory upper GIT symptoms
Time Frame: Baseline
clarify the role of HRM in diagnosis of refractory upper GIT symptoms
Baseline

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

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.

Clinical Trials on Esophageal Motility Disorders

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