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NCT Number: NCT07239934

Pediatric GI Endoscopy at Assiut University

1. To evaluate the diagnostic role, and outcomes of upper and lower gastrointestinal (GI) endoscopy in identifying gastrointestinal disorders among infants and pediatric patients attending Assiut University Children Hospital. 2. To determine which pediatric patients require endoscopy as part of the diagnostic process. 3. To assess the safety and effectiveness of endoscopic procedures in the detection and management of various gastrointestinal disorders among pediatric patients at Assiut University Children Hospital.

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Key information

About this study

Pediatric endoscopy plays a pivotal role in the diagnosis and management of various gastrointestinal and hepatological disorders in children.It allows doctors to see inside the digestive system, identify problems, and sometimes even treat them during the same procedure. It is a rapidly evolving field, with continuous advancements in both endoscopic technology and procedural skills, making it a safe, effective, and reliable diagnostic and therapeutic tool. Today, pediatric endoscopy is considered an essential part of evaluating and treating a wide range of gastrointestinal conditions in children. Accurate and timely diagnosis of gastrointestinal disorders is critical to prevent complications, reduce morbidity, and ensure appropriate management. These disorders are among the most common health problems affecting children worldwide. They often present with a wide variety of symptoms, including failure to thrive, unexplained anemia, recurrent vomiting, dysphagia (difficulty swallowing), acute epigastric pain, foreign body ingestion, hematemesis (vomiting blood), melena (black, tarry stools), abdominal pain, rectal bleeding, bloody diarrhea, and chronic diarrhea. At Assiut University Children Hospital, a major tertiary care center serving Upper Egypt. In recent years, there has been growing use of gastrointestinal endoscopy as a main method for diagnosing and treating various GI conditions. IT includes foreign body removal, management of caustic ingestion injuries, treatment of esophageal strictures, assessment of gastroesophageal reflux disease (GERD) severity, diagnosis of Helicobacter pylori infection through endoscopic biopsy, evaluation of eosinophilic esophagitis, management of variceal and non-variceal gastrointestinal bleeding such as deep ulcerations and gastroduodenal vascular malformations. In addition, ileocolonoscopy is commonly performed to assess lower gastrointestinal disorders such as juvenile polyps, inflammatory bowel disease (IBD), allergic colitis, vascular malformations, and infectious colitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged from 1day to 18 years undergoing diagnostic endoscopy.

Exclusion criteria

  • Incomplete patient data.
  • Patients undergoing follow-up procedures.

Treatment and study plan

Gastrointestinal Endoscopy

Procedure

Children undergoing evaluation for gastrointestinal symptoms (such as abdominal pain, bleeding, vomiting, chronic diarrhea, suspected foreign body ingestion, or growth failure) will undergo diagnostic gastrointestinal endoscopy (upper or lower as clinically indicated). The procedure will be performed under appropriate sedation/anesthesia using a standard pediatric endoscope. During endoscopy, visualization of the mucosa will be carried out, and biopsies may be taken if needed for histopathological examination.

Primary outcomes

  1. Diagnostic yield of gastrointestinal endoscopy

    Time frame: Within 30 days after endoscopy.

    Proportion (%) of pediatric patients in whom gastrointestinal endoscopy provides a definitive diagnosis based on endoscopic and histopathological findings.

  2. Distribution of clinical indications for pediatric endoscopy

    Time frame: At the time of endoscopy.

    Proportion (%) of children undergoing endoscopy for each indication (e.g., abdominal pain, GI bleeding, chronic diarrhea).

  3. Correlation between clinical suspicion and confirmed diagnosis

    Time frame: Within 30 days after endoscopy.

    Level of agreement between pre-procedure clinical suspicion and final diagnosis based on endoscopic and histopathological findings (reported as percentage concordance).

Secondary outcomes

  1. Types and frequencies of gastrointestinal disorders diagnosed by endoscopy

    Time frame: Within 30 days after endoscopy.

    Frequency distribution of gastrointestinal disorders diagnosed in pediatric patients undergoing endoscopy.

  2. Safety and complication rates of pediatric endoscopy

    Time frame: From the time of endoscopy until 7 days post-procedure.

    Incidence (%) of procedure-related complications (e.g., bleeding, perforation, infection).

  3. change in awareness among healthcare providers

    Time frame: Up to 6 months from start of study.

    Change in awareness and knowledge about pediatric gastrointestinal endoscopy, assessed by structured questionnaire score before and after educational sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Aml Shaban, MBBS

CONTACT

[email protected]

+201066154318

Rehab Ibrahim, MD

CONTACT

+20 10 09272624

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Diagnostic Role of Gastrointestinal Endoscopy in Assiut University Children Hospital

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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