Esophageal Motility DisordersNCT05402462
Esophageal Motility Disorders in Patients With Non-cardiac Chest Pain at Assiut University Hospital
An observational study of Esophageal Motility Disorders, run by Assiut University.
Trial summary
to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- upper endoscopy
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring
Who may be able to join
- Age above 18 years
- Patients presented with non-cardiac chest pain
Who cannot join
- 1- age below 18. 2- cardiac chest pain patients
Trial locations and contacts
No sites are listed yet.
Alaa Eldeen Abd Elmonem, professor contact
About this study
to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring
Read the detailed description
Non-cardiac chest pain (NCCP) is defined as recurrent anginalike pain without evidence of cardiac disease [1]. NCCP is a common disorder and accounts for 14-33% of patient visits to gastroenterologists [2]. These patients frequently undergo testing for reflux and esophageal motility as gastroesophageal reflux disease (GERD) is seen in 50-60% and esophageal motility disorders in 15-18% of the patients [3,4]. Nutcracker esophagus was thought to be the classic manometric finding in NCCP [5] but other studies have reported ineffective esophageal motility (IEM) as the most common motility disorder in NCCP [6,7]. Furthermore, up to one-third of patients do not have any GERD or motility disorders and are labeled as functional chest pain [8]. Suggested causes in these patients include esophageal hypersensitivity [9], abnormal cerebral pain processing and psychological comorbidity [10]. The clinical predictors of abnormal esophageal function tests in NCCP have not been identified. Identifying these factors would lead to limited use of testing in those with risk factors and faster institution of pain modulator therapy in patients who are most likely to have functional chest pain.
- Conditions
- Esophageal Motility Disorders
- Being tested
- upper endoscopy
- Medical subject headings
- Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper endoscopyDiagnostic test
Also called esophageal manometry
detect esphageal motility disorder by upper endoscopy and esophageal manometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal motility disorders in patients with non-cardiac chest pain at Assiut University hospital
Determine esophageal motility disorder in patient with non cardiac chest pain using ECG ,cardiac enzymes and echocardiography , esophageal manometry and upper endoscopy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa medhat Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402462
- Sponsor's protocol ID
- Esophageal motility disorders
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fass R, Achem SR. Noncardiac chest pain: epidemiology, natural course and pathogenesis. J Neurogastroenterol Motil. 2011 Apr;17(2):110-23. doi: 10.5056/jnm.2011.17.2.110. Epub 2011 Apr 27.
PubMed 21602987Yamasaki T, Fass R. Noncardiac chest pain: diagnosis and management. Curr Opin Gastroenterol. 2017 Jul;33(4):293-300. doi: 10.1097/MOG.0000000000000374.
PubMed 28463855Coss-Adame E, Rao SS. A Review of Esophageal Chest Pain. Gastroenterol Hepatol (N Y). 2015 Nov;11(11):759-66.
PubMed 27134590Fass R, Dickman R. Non-cardiac chest pain: an update. Neurogastroenterol Motil. 2006 Jun;18(6):408-17. doi: 10.1111/j.1365-2982.2006.00787.x.
PubMed 16700719Katz PO, Dalton CB, Richter JE, Wu WC, Castell DO. Esophageal testing of patients with noncardiac chest pain or dysphagia. Results of three years' experience with 1161 patients. Ann Intern Med. 1987 Apr;106(4):593-7. doi: 10.7326/0003-4819-106-4-593.
PubMed 3826958Ribolsi M, Balestrieri P, Biasutto D, Emerenziani S, Cicala M. Role of Mixed Reflux and Hypomotility with Delayed Reflux Clearance in Patients with Non-cardiac Chest Pain. J Neurogastroenterol Motil. 2016 Oct 30;22(4):606-612. doi: 10.5056/jnm15182.
PubMed 27095707Barret M, Herregods TV, Oors JM, Smout AJ, Bredenoord AJ. Diagnostic yield of 24-hour esophageal manometry in non-cardiac chest pain. Neurogastroenterol Motil. 2016 Aug;28(8):1186-93. doi: 10.1111/nmo.12818. Epub 2016 Mar 27.
PubMed 27018150Remes-Troche JM. How to Diagnose and Treat Functional Chest Pain. Curr Treat Options Gastroenterol. 2016 Dec;14(4):429-443. doi: 10.1007/s11938-016-0106-y.
PubMed 27709331Farmer AD, Ruffle JK, Aziz Q. The Role of Esophageal Hypersensitivity in Functional Esophageal Disorders. J Clin Gastroenterol. 2017 Feb;51(2):91-99. doi: 10.1097/MCG.0000000000000757.
PubMed 28005634Zhang L, Tu L, Chen J, Song J, Bai T, Xiang XL, Wang RY, Hou XH. Health-related quality of life in gastroesophageal reflux patients with noncardiac chest pain: Emphasis on the role of psychological distress. World J Gastroenterol. 2017 Jan 7;23(1):127-134. doi: 10.3748/wjg.v23.i1.127.
PubMed 28104988
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Motility Disorders in Patients With Non-cardiac Chest Pain at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05402462
- Acronym / sponsor ID
- Esophageal motility disorders
- Conditions
- Esophageal Motility Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 2 Jun 2022 (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.
to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring
Detailed description
Non-cardiac chest pain (NCCP) is defined as recurrent anginalike pain without evidence of cardiac disease [1]. NCCP is a common disorder and accounts for 14-33% of patient visits to gastroenterologists [2]. These patients frequently undergo testing for reflux and esophageal motility as gastroesophageal reflux disease (GERD) is seen in 50-60% and esophageal motility disorders in 15-18% of the patients [3,4]. Nutcracker esophagus was thought to be the classic manometric finding in NCCP [5] but other studies have reported ineffective esophageal motility (IEM) as the most common motility disorder in NCCP [6,7]. Furthermore, up to one-third of patients do not have any GERD or motility disorders and are labeled as functional chest pain [8]. Suggested causes in these patients include esophageal hypersensitivity [9], abnormal cerebral pain processing and psychological comorbidity [10]. The clinical predictors of abnormal esophageal function tests in NCCP have not been identified. Identifying these factors would lead to limited use of testing in those with risk factors and faster institution of pain modulator therapy in patients who are most likely to have functional chest pain.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring
Key inclusion criteria (2 listed)
- Age above 18 years
- Patients presented with non-cardiac chest pain
Key exclusion criteria (1 listed)
- 1- age below 18. 2- cardiac chest pain patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper endoscopyAlso: esophageal manometrydetect esphageal motility disorder by upper endoscopy and esophageal manometry | Diagnostic test | – |
Primary outcome
Esophageal motility disorders in patients with non-cardiac chest pain at Assiut University hospital
Time frame: one year
Determine esophageal motility disorder in patient with non cardiac chest pain using ECG ,cardiac enzymes and echocardiography , esophageal manometry and upper endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Results publication: PubMed 21602987Fass R, Achem SR. Noncardiac chest pain: epidemiology, natural course and pathogenesis. J Neurogastroenterol Motil. 2011 Apr;17(2):110-23. doi: 10.5056/jnm.2011.17.2.110. Epub 2011 Apr 27.
- Results publication: PubMed 28463855Yamasaki T, Fass R. Noncardiac chest pain: diagnosis and management. Curr Opin Gastroenterol. 2017 Jul;33(4):293-300. doi: 10.1097/MOG.0000000000000374.
- Results publication: PubMed 27134590Coss-Adame E, Rao SS. A Review of Esophageal Chest Pain. Gastroenterol Hepatol (N Y). 2015 Nov;11(11):759-66.
- Results publication: PubMed 16700719Fass R, Dickman R. Non-cardiac chest pain: an update. Neurogastroenterol Motil. 2006 Jun;18(6):408-17. doi: 10.1111/j.1365-2982.2006.00787.x.
- Results publication: PubMed 3826958Katz PO, Dalton CB, Richter JE, Wu WC, Castell DO. Esophageal testing of patients with noncardiac chest pain or dysphagia. Results of three years' experience with 1161 patients. Ann Intern Med. 1987 Apr;106(4):593-7. doi: 10.7326/0003-4819-106-4-593.
- Results publication: PubMed 27095707Ribolsi M, Balestrieri P, Biasutto D, Emerenziani S, Cicala M. Role of Mixed Reflux and Hypomotility with Delayed Reflux Clearance in Patients with Non-cardiac Chest Pain. J Neurogastroenterol Motil. 2016 Oct 30;22(4):606-612. doi: 10.5056/jnm15182.
- Results publication: PubMed 27018150Barret M, Herregods TV, Oors JM, Smout AJ, Bredenoord AJ. Diagnostic yield of 24-hour esophageal manometry in non-cardiac chest pain. Neurogastroenterol Motil. 2016 Aug;28(8):1186-93. doi: 10.1111/nmo.12818. Epub 2016 Mar 27.
- Results publication: PubMed 27709331Remes-Troche JM. How to Diagnose and Treat Functional Chest Pain. Curr Treat Options Gastroenterol. 2016 Dec;14(4):429-443. doi: 10.1007/s11938-016-0106-y.
- Results publication: PubMed 28005634Farmer AD, Ruffle JK, Aziz Q. The Role of Esophageal Hypersensitivity in Functional Esophageal Disorders. J Clin Gastroenterol. 2017 Feb;51(2):91-99. doi: 10.1097/MCG.0000000000000757.
- Results publication: PubMed 28104988Zhang L, Tu L, Chen J, Song J, Bai T, Xiang XL, Wang RY, Hou XH. Health-related quality of life in gastroesophageal reflux patients with noncardiac chest pain: Emphasis on the role of psychological distress. World J Gastroenterol. 2017 Jan 7;23(1):127-134. doi: 10.3748/wjg.v23.i1.127.
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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.
Alaa Eldeen Abd Elmonem, professor contact
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 1 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 2 Jun 2022. 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 Esraa Medhat, resident doctor (01099071931, esraamedhat449@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal motility disorders in patients with non-cardiac chest pain at Assiut University hospital (time frame: one year). 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 NCT05402462, which also lists 10 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 2 Jun 2022.