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Набор скоро начнётся NCT07372976

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

Наблюдательное Pediatric Gastrointestinal Disorders Chronic Abdominal Pain in Children Upper Endoscopy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Upper Gastrointestinal Endoscopy.
Кому может быть актуально
Состояния в реестре: Pediatric Gastrointestinal Disorders, Chronic Abdominal Pain in Children, Upper Endoscopy. Базовые параметры: 0 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест Upper Gastrointestinal Endoscopy
    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.

Первичные конечные точки

  • Diagnostic Yield of Upper Gastrointestinal Endoscopy [Срок оценки: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)]
Вторичные конечные точки (3)
  • Pattern of Endoscopic and Histopathological Findings [Срок оценки: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)]
  • Association Between Alarm Features and Abnormal Endoscopic Findings [Срок оценки: At the time of upper gastrointestinal endoscopy during the study period (January 2026-December 2026)]
  • Severity of Abdominal Pain in Relation to Endoscopic Findings [Срок оценки: At the time of clinical assessment and upper gastrointestinal endoscopy during the study period (January 2026-December 2026)]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Египет · 1 центр
  • Assiut university — Asyut

Публикации

  • 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 17494020

Идентификаторы

NCT: NCT07372976 · AUC-PED-GI-CAP-2026

Первоисточники (государственные реестры)

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