Pediatric GI Endoscopy at Assiut University

November 16, 2025 updated by: Aml Shaban Mohamed Farghly, Assiut University

Diagnostic Role of Gastrointestinal Endoscopy in Assiut University Children Hospital

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Rehab Ibrahim, MD
  • Phone Number: +20 10 09272624

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71515
        • Endoscopic Centre at Assiut University Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children admitted to Assiut University Children Hospital who present with gastrointestinal symptoms (such as abdominal pain, vomiting, hematemesis, melena, diarrhea, or unexplained anemia) and are referred for diagnostic gastrointestinal endoscopy as part of their clinical evaluation.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 30 days after endoscopy.
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).
At the time of endoscopy.
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).
Within 30 days after endoscopy.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 30 days after endoscopy.
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).
From the time of endoscopy until 7 days post-procedure.
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.
Up to 6 months from start of study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Khalid Abd elaziz, MD, Assiut University, Faculty of Medicine, Children Hospital
  • Study Director: rehab ibrahim, MD, Assiut University, Faculty of Medicine, Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • endoscopy in AUCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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