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临床试验/NCT07372976
NCT07372976尚未招募不适用

The Role and Outcome of Upper Gastrointestinal Endoscopy in Children Presenting With Chronic Abdominal Pain at Assiut University Children Hospital

Assiut University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
130
试验地点
1
主要终点
Diagnostic Yield of Upper Gastrointestinal Endoscopy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Upper Gastrointestinal Endoscopy (Diagnostic Test)

结局指标

主要结局

Diagnostic Yield of Upper Gastrointestinal Endoscopy

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Randa Mahmoud Amin Mahran

Randa Mahmoud Amin Mahran

Assiut University

研究点 (1)

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