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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05402462
Other study ID # Esophageal motility disorders
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 30, 2022
Est. completion date April 30, 2024

Study information

Verified date February 2022
Source Assiut University
Contact Esraa Medhat, resident doctor
Phone 01099071931
Email esraamedhat449@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date April 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age above 18 years 2. Patients presented with non-cardiac chest pain Exclusion Criteria: - 1- age below 18. 2- cardiac chest pain patients

Study Design


Intervention

Diagnostic Test:
upper endoscopy
detect esphageal motility disorder by upper endoscopy and esophageal manometry

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (10)

Barret 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. — View Citation

Coss-Adame E, Rao SS. A Review of Esophageal Chest Pain. Gastroenterol Hepatol (N Y). 2015 Nov;11(11):759-66. — View Citation

Farmer 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. Review. — View Citation

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. — View Citation

Fass R, Dickman R. Non-cardiac chest pain: an update. Neurogastroenterol Motil. 2006 Jun;18(6):408-17. Review. — View Citation

Katz 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. — View Citation

Remes-Troche JM. How to Diagnose and Treat Functional Chest Pain. Curr Treat Options Gastroenterol. 2016 Dec;14(4):429-443. Review. — View Citation

Ribolsi 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. — View Citation

Yamasaki T, Fass R. Noncardiac chest pain: diagnosis and management. Curr Opin Gastroenterol. 2017 Jul;33(4):293-300. doi: 10.1097/MOG.0000000000000374. Review. — View Citation

Zhang 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one year
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