Prevalence of IEM Among Upper GIT Symptoms

Esophageal Motility Disorders Clinical Trial

Official title:

Prevalence of Ineffective Esophageal Motility Among Upper Gastrointestinal Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05913011
• Other study ID #: Prevalence of IEM among U GIT
• Status: Not yet recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse

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