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Pediatric Gastrointestinal DisordersUGI-CAPNCT07372976

Role and Diagnostic Yield of Upper Endoscopy in Children With Chronic Abdominal Pain

An observational study of Pediatric Gastrointestinal Disorders and Chronic Abdominal Pain in Children, run by Assiut University at 1 site in Egypt.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 0 to 18 years
What is being tested?
Upper Gastrointestinal Endoscopy
How many people
130 participants
Where
1 siteEgypt
Study dates
Mar 2026to Dec 2026
Phase
Observational

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 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • Children aged ≤18 years.
  • Suffering from chronic abdominal pain lasting ≥3 months.
  • Undergoing upper gastrointestinal endoscopy at Assiut University Children Hospital.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Assiut university

    Asyut

    Assiut University, 08822080150, vp_grad@aun.edu.eg

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Upper Gastrointestinal Endoscopy
Keywords
Chronic abdominal pain, Paediatric abdominal pain, Functional abdominal pain, Organic gastrointestinal disease, Children, Alarm symptoms, Upper gastrointestinal endoscopy, Paediatric gastroenterology, Esophagogastroduodenoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper Gastrointestinal EndoscopyDiagnostic test

    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.

Study groups in NCT07372976
Study groupRoleWhat they receive
Children with chronic abdominal painThis 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.
Receives: Diagnostic Test: Upper Gastrointestinal Endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Yield of Upper Gastrointestinal Endoscopy

    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.

    Measured: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)

Secondary outcomes (3)
  1. Pattern of Endoscopic and Histopathological Findings

    Assessment of the types and frequencies of abnormal endoscopic findings (esophageal, gastric, and duodenal) and corresponding histopathological diagnoses among children with chronic abdominal pain.

    Measured: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)

  2. Association Between Alarm Features and Abnormal Endoscopic Findings

    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.

    Measured: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)

  3. Severity of Abdominal Pain in Relation to Endoscopic Findings

    Correlation between abdominal pain severity assessed using a standardized pain score and the presence or absence of abnormal endoscopic or histopathological findings.

    Measured: At the time of clinical assessment and upper gastrointestinal endoscopy during the study period (January 2026-December 2026)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07372976
Sponsor's protocol ID
AUC-PED-GI-CAP-2026
Acronym
UGI-CAP
Status last verified
Mar 2026
First submitted
20 Jan 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Adeniyi OF, Odeghe EA, Lawal MA, Olowu AO, Ademuyiwa A. Recurrent abdominal pain and upper gastrointestinal endoscopy findings in children and adolescents presenting at the Lagos University Teaching Hospital. PLoS One. 2019 May 23;14(5):e0216394. doi: 10.1371/journal.pone.0216394. eCollection 2019.

    PubMed 31120915
  • Thakkar K, Dorsey F, Gilger MA. Impact of endoscopy on management of chronic abdominal pain in children. Dig Dis Sci. 2011 Feb;56(2):488-93. doi: 10.1007/s10620-010-1315-1. Epub 2010 Jul 2.

    PubMed 20596777
  • Wani MA, Zargar SA, Yatoo GN, Haq I, Shah A, Sodhi JS, Gulzar GM, Khan M. Endoscopic Yield, Appropriateness, and Complications of Pediatric Upper Gastrointestinal Endoscopy in an Adult Suite: A Retrospective Study of 822 Children. Clin Endosc. 2020 Jul;53(4):436-442. doi: 10.5946/ce.2019.118. Epub 2020 Apr 7.

    PubMed 32252499
  • Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.

    PubMed 16928254
  • Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):908-917. doi: 10.1016/S2468-1253(20)30217-X. Epub 2020 Jul 20.

    PubMed 32702295
  • Berger MY, Gieteling MJ, Benninga MA. Chronic abdominal pain in children. BMJ. 2007 May 12;334(7601):997-1002. doi: 10.1136/bmj.39189.465718.BE. No abstract available.

    PubMed 17494020

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