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

NCT07372976 | Not Yet Recruiting

• 1 other identifier: AUC-PED-GI-CAP-2026
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Upper Endoscopy; Pediatric Gastrointestinal Disorders; Chronic Abdominal Pain in Children

Keywords

Chronic abdominal pain; Paediatric abdominal pain; Functional abdominal pain; Organic gastrointestinal disease; Children; Alarm symptoms; Upper gastrointestinal endoscopy; Paediatric gastroenterology; Esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Pattern of Endoscopic and Histopathological Findings

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

• Association Between Alarm Features and Abnormal Endoscopic 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

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

Study Arms (1)

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.

Diagnostic Test: Upper Gastrointestinal Endoscopy

Interventions

Upper Gastrointestinal Endoscopy DIAGNOSTIC_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.

Children with chronic abdominal pain

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (6)

• Adeniyi OF, et al. Recurrent abdominal pain and upper gastrointestinal endoscopy findings in children and adolescents. PLoS One. 2019;14(5).

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Vakil N, et al. The Montreal definition and classification of gastroesophageal reflux disease. Am J Gastroenterol. 2006;101(8).

  BACKGROUND

• 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.

  BACKGROUND

• Berger MY, Gieteling MJ, Benninga MA. Chronic abdominal pain in children. BMJ. 2007;334(7601):997-1002. doi:10.1136/BMJ.39189.465718.BE

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy specimens are obtained for histopathological diagnosis only, with no genetic or DNA analysis planned.

MeSH Terms

Interventions

Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Randa Mahmoud Mahran

CONTACT

0201009110785; randa.mahmoud0959@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Randa Mahmoud Amin Mahran

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)