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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05913011
Other study ID # Prevalence of IEM among U GIT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2023
Est. completion date September 2024

Study information

Verified date June 2023
Source Assiut University
Contact Aya Ahmed Otify, Resident doc
Phone 01144131480
Email ayaatafy0@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 2024
Est. primary completion date August 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Schlottmann F, Patti MG. Primary Esophageal Motility Disorders: Beyond Achalasia. Int J Mol Sci. 2017 Jun 30;18(7):1399. doi: 10.3390/ijms18071399. — View Citation

Zhuang QJ, Tan ND, Zhang MY, Chen SF, Luo Y, Xiao YL. Ineffective esophageal motility in Chicago Classification version 4.0 better predicts abnormal acid exposure. Esophagus. 2022 Jan;19(1):197-203. doi: 10.1007/s10388-021-00867-5. Epub 2021 Aug 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary detect the prevalence of IEM among upper git symptom detect the prevalence of IEM among upper git symptom Basline
Primary clarify the role of HRM in diagnosis of refractory upper GIT symptoms clarify the role of HRM in diagnosis of refractory upper GIT symptoms Baseline
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