Clinical trial NCT05913011: Prevalence of IEM Among Upper GIT Symptoms
Official title: Prevalence of Ineffective Esophageal Motility Among Upper Gastrointestinal Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Motility Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient bove the age of 18 years old presented with upper git symptoms

Brief summary: * detect the prevalence of IEM among upper git symptom .
* clarify the role of HRM in diagnosis of refractory upper GIT symptoms.

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.

Eligibility criteria: 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

Primary outcomes:
measure: detect the prevalence of IEM among upper git symptom
timeFrame: Basline
measure: clarify the role of HRM in diagnosis of refractory upper GIT symptoms
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: Schlottmann F, Patti MG. Primary Esophageal Motility Disorders: Beyond Achalasia. Int J Mol Sci. 2017 Jun 30;18(7):1399. doi: 10.3390/ijms18071399.