Esophageal Motility DisordersNCT05913011
Prevalence of IEM Among Upper GIT Symptoms
An observational study of Esophageal Motility Disorders, run by Assiut University.
Trial summary
detect the prevalence of IEM among upper git symptom . clarify the role of HRM in diagnosis of refractory upper GIT symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Motility Disorders
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patient bove the age of 18 years old presented with upper git symptoms
Who may be able to join
- patient bove the age of 18 years old
- All patient presented with upper git symptoms
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Motility Disorders
- Medical subject headings
- Esophageal Motility Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
detect the prevalence of IEM among upper git symptom
detect the prevalence of IEM among upper git symptom
Measured: Basline
clarify the role of HRM in diagnosis of refractory upper GIT symptoms
clarify the role of HRM in diagnosis of refractory upper GIT symptoms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Otify, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913011
- Sponsor's protocol ID
- Prevalence of IEM among U GIT
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34378104Schlottmann F, Patti MG. Primary Esophageal Motility Disorders: Beyond Achalasia. Int J Mol Sci. 2017 Jun 30;18(7):1399. doi: 10.3390/ijms18071399.
PubMed 28665309
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Ineffective Esophageal Motility Among Upper Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT05913011
- Acronym / sponsor ID
- Prevalence of IEM among U GIT
- Conditions
- Esophageal Motility Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient bove the age of 18 years old presented with upper git symptoms
Key inclusion criteria (2 listed)
- patient bove the age of 18 years old
- All patient presented with upper git symptoms
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
detect the prevalence of IEM among upper git symptom
Time frame: Basline
detect the prevalence of IEM among upper git symptom
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 34378104Zhuang 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.
- Background: PubMed 28665309Schlottmann F, Patti MG. Primary Esophageal Motility Disorders: Beyond Achalasia. Int J Mol Sci. 2017 Jun 30;18(7):1399. doi: 10.3390/ijms18071399.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Motility Disorders, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Ahmed Otify, Resident doc (01144131480, ayaatafy0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect the prevalence of IEM among upper git symptom (time frame: Basline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913011, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.