- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239934
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
- 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.
- To determine which pediatric patients require endoscopy as part of the diagnostic process.
- 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
Not yet recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
- Name: Aml Shaban, MBBS
- Phone Number: +201066154318
- Email: amaal.17305794@med.aun.edu.eg
Study Contact Backup
- Name: Rehab Ibrahim, MD
- Phone Number: +20 10 09272624
Study Locations
-
-
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
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
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
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
Investigators
- 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
- Bohara TP, Laudari U, Thapa A, Rupakheti S, Joshi MR. Appropriateness of Indications of Upper Gastrointestinal Endoscopy and its Association With Positive Finding. JNMA J Nepal Med Assoc. 2018 Jan-Feb;56(209):504-509.
- Schluckebier D, Afzal NA, Thomson M. Therapeutic Upper Gastrointestinal Endoscopy in Pediatric Gastroenterology. Front Pediatr. 2022 Feb 25;9:715912. doi: 10.3389/fped.2021.715912. eCollection 2021.
- Tringali A, Thomson M, Dumonceau JM, Tavares M, Tabbers MM, Furlano R, Spaander M, Hassan C, Tzvinikos C, Ijsselstijn H, Viala J, Dall'Oglio L, Benninga M, Orel R, Vandenplas Y, Keil R, Romano C, Brownstone E, Hlava S, Gerner P, Dolak W, Landi R, Huber WD, Everett S, Vecsei A, Aabakken L, Amil-Dias J, Zambelli A. Pediatric gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) and European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) Guideline Executive summary. Endoscopy. 2017 Jan;49(1):83-91. doi: 10.1055/s-0042-111002. Epub 2016 Sep 12.
- Fachler T, Shteyer E, Orlanski Meyer E, Shemasna I, Lev Tzion R, Rachman Y, Bergwerk A, Turner D, Ledder O. Pediatric Gastrointestinal Endoscopy: Diagnostic Yield and Appropriateness of Referral Based on Clinical Presentation: A Pilot Study. Front Pediatr. 2021 Oct 29;9:607418. doi: 10.3389/fped.2021.607418. eCollection 2021.
- Ngo PD, Lightdale JR. Advances in Pediatric Endoscopy. Gastroenterol Clin North Am. 2024 Dec;53(4):539-555. doi: 10.1016/j.gtc.2024.08.010. Epub 2024 Sep 30.
- Franciosi JP, Fiorino K, Ruchelli E, Shults J, Spergel J, Liacouras CA, Leonard M. Changing indications for upper endoscopy in children during a 20-year period. J Pediatr Gastroenterol Nutr. 2010 Oct;51(4):443-7. doi: 10.1097/MPG.0b013e3181d67bee.
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)
January 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
September 23, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 16, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Digestive System Diseases
- Gastrointestinal Diseases
- Hemorrhage
- Esophageal Diseases
- Otorhinolaryngologic Diseases
- Pharyngeal Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Deglutition Disorders
- Gastrointestinal Hemorrhage
- Failure to Thrive
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy, Digestive System
- Diagnostic Techniques, Digestive System
- Endoscopy
- Digestive System Surgical Procedures
- Endoscopy, Gastrointestinal
Other Study ID 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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