- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07372976
Role and Diagnostic Yield of Upper Endoscopy in Children With Chronic Abdominal Pain (UGI-CAP)
The Role and Outcome of Upper Gastrointestinal Endoscopy in Children Presenting With Chronic Abdominal Pain at Assiut University Children Hospital
Chronic abdominal pain is a common problem in children and may be caused by functional or organic gastrointestinal disorders. While many children have no identifiable structural disease, some may have conditions that can be detected by upper gastrointestinal endoscopy. This study aims to evaluate the role and diagnostic outcome of upper gastrointestinal endoscopy in children presenting with chronic abdominal pain at Assiut University Children Hospital.
Children aged 18 years or younger who have had abdominal pain for at least three months and who undergo upper gastrointestinal endoscopy as part of their routine medical care will be included. Clinical symptoms, alarm features, endoscopic findings, and biopsy results will be analyzed to determine how often endoscopy identifies an organic cause of pain. The results of this study may help guide the appropriate use of endoscopy in the evaluation of chronic abdominal pain in children.
Study Overview
Status
Intervention / Treatment
Detailed Description
Chronic abdominal pain in children represents a frequent and challenging clinical problem. Although the majority of affected children suffer from functional gastrointestinal disorders, a significant proportion may have underlying organic diseases such as gastritis, gastroesophageal reflux disease, peptic ulcer disease, celiac disease, or other inflammatory conditions. Differentiating between functional and organic causes is essential to guide appropriate management and avoid unnecessary investigations.
Upper gastrointestinal endoscopy allows direct visualization of the esophagus, stomach, and duodenum, as well as the ability to obtain tissue biopsies for histopathological evaluation. Despite its diagnostic potential, the routine use of endoscopy in children with chronic abdominal pain remains controversial, particularly in the absence of alarm symptoms. Current guidelines suggest that endoscopy should be reserved for selected patients, but data on its diagnostic yield in pediatric populations remain limited.
This analytic cross-sectional observational study will be conducted at the Pediatric Gastroenterology and Hepatology Unit of Assiut University Children Hospital over a one-year period from January 2026 to December 2026. The study will include children aged 18 years or younger who present with chronic abdominal pain lasting at least three months and who undergo upper gastrointestinal endoscopy as part of their clinical evaluation.
All enrolled patients will undergo detailed clinical assessment, including medical history, evaluation of abdominal pain characteristics, presence of dyspeptic symptoms, and identification of alarm features such as weight loss, poor growth, gastrointestinal bleeding, persistent vomiting, chronic diarrhea, unexplained fever, abdominal mass, or organomegaly. Pain severity will be assessed using a standardized pain scoring scale. Physical examination findings and relevant laboratory investigations performed prior to endoscopy will be recorded.
Upper gastrointestinal endoscopy findings, including esophageal, gastric, and duodenal abnormalities, will be documented. Biopsy specimens obtained during the procedure will be examined histopathologically, and the results will be correlated with clinical and endoscopic findings. The primary outcome of the study is the diagnostic yield of upper gastrointestinal endoscopy, defined as the proportion of patients with abnormal endoscopic and/or histopathological findings. Secondary outcomes include the pattern of endoscopic diagnoses and the association between alarm features and abnormal findings.
Data will be analyzed using appropriate statistical methods to describe clinical characteristics and outcomes. The findings of this study are expected to provide valuable insight into the usefulness of upper gastrointestinal endoscopy in children with chronic abdominal pain and may help refine clinical decision-making regarding its appropriate use in pediatric practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Randa Mahmoud Mahran
- Phone Number: 0201009110785
- Email: randa.mahmoud0959@med.aun.edu.eg
Study Locations
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Asyut, Egypt
- Assiut University
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Contact:
- Assiut University
- Phone Number: 08822080150
- Email: vp_grad@aun.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged ≤18 years.
- Suffering from chronic abdominal pain lasting ≥3 months.
- Undergoing upper gastrointestinal endoscopy at Assiut University Children Hospital.
Exclusion Criteria:
- Pre-existing chronic diseases that may alter symptoms, such as inflammatory bowel disease or liver disease (unless these are diagnosed as a result of the study).
- Patients with "alarm symptoms" that require urgent, immediate intervention, such as active gastrointestinal bleeding.
- Patients or guardians who refuse to participate.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children with chronic abdominal pain
This group includes children aged 18 years or younger presenting with chronic abdominal pain lasting at least three months who undergo upper gastrointestinal endoscopy as part of their routine clinical evaluation at Assiut University Children Hospital.
Clinical features, alarm symptoms, endoscopic findings, and histopathological results will be analyzed.
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Upper gastrointestinal endoscopy (esophagogastroduodenoscopy) is performed as part of standard clinical care to evaluate children with chronic abdominal pain.
The procedure allows direct visualization of the esophagus, stomach, and duodenum, with biopsy sampling when clinically indicated for histopathological examination.
The procedure is not assigned by the study protocol but is analyzed observationally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic Yield of Upper Gastrointestinal Endoscopy
Time Frame: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Diagnostic yield is defined as the proportion of children with chronic abdominal pain who have abnormal findings detected by upper gastrointestinal endoscopy and/or histopathological examination of biopsy specimens.
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At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pattern of Endoscopic and Histopathological Findings
Time Frame: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Assessment of the types and frequencies of abnormal endoscopic findings (esophageal, gastric, and duodenal) and corresponding histopathological diagnoses among children with chronic abdominal pain.
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At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Association Between Alarm Features and Abnormal Endoscopic Findings
Time Frame: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Evaluation of the relationship between the presence of alarm symptoms (such as weight loss, gastrointestinal bleeding, persistent vomiting, poor growth, or chronic diarrhea) and abnormal upper gastrointestinal endoscopic or histopathological findings.
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At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Severity of Abdominal Pain in Relation to Endoscopic Findings
Time Frame: At the time of clinical assessment and upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Correlation between abdominal pain severity assessed using a standardized pain score and the presence or absence of abnormal endoscopic or histopathological findings.
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At the time of clinical assessment and upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Adeniyi OF, et al. Recurrent abdominal pain and upper gastrointestinal endoscopy findings in children and adolescents. PLoS One. 2019;14(5).
- Thakkar K, Dorsey F, Gilger MA. Impact of Endoscopy on Management of Chronic Abdominal Pain in Children. Dig Dis Sci. 2010;56(2):488-493.
- Wani MA, et al. Endoscopic Yield, Appropriateness, and Complications of Pediatric Upper Gastrointestinal Endoscopy in an Adult Suite. Clin Endosc. 2020;53(4):436-442.
- Vakil N, et al. The Montreal definition and classification of gastroesophageal reflux disease. Am J Gastroenterol. 2006;101(8).
- Oka P, et al. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria. Lancet Gastroenterol Hepatol. 2020;5(10):908-917.
- Berger MY, Gieteling MJ, Benninga MA. Chronic abdominal pain in children. BMJ. 2007;334(7601):997-1002. doi:10.1136/BMJ.39189.465718.BE
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUC-PED-GI-CAP-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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