Role and Diagnostic Yield of Upper Endoscopy in Children With Chronic Abdominal Pain (UGI-CAP)

March 15, 2026 updated by: Randa Mahmoud Amin Mahran, Assiut University

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

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

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Asyut, Egypt
        • Assiut University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population consists of pediatric patients (up to 18 years old) presenting to the pediatric gastroenterology and hepatology unit of Assiut University Children Hospital with a primary complaint of chronic abdominal pain lasting at least 3 months. The estimated sample size is approximately 130 pediatric patients.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Yield of Upper Gastrointestinal Endoscopy
Time Frame: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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.
At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of Endoscopic and Histopathological Findings
Time Frame: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
Assessment of the types and frequencies of abnormal endoscopic findings (esophageal, gastric, and duodenal) and corresponding histopathological diagnoses among children with chronic abdominal pain.
At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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)
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.
At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)
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)
Correlation between abdominal pain severity assessed using a standardized pain score and the presence or absence of abnormal endoscopic or histopathological findings.
At the time of clinical assessment and upper gastrointestinal endoscopy during the study period (January 2026-December 2026)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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