Pediatric GI Endoscopy at Assiut University

NCT07239934 | Not Yet Recruiting

• 1 other identifier: endoscopy in AUCH
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To determine which pediatric patients require endoscopy as part of the diagnostic process.
3. 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.

Conditions

Chronic Diarrhea; Persistent Vomitting; Gastrointestinal Bleeding; Dysphagia; Foreign Body Ingestion; Failure to Thrive; Pediatric Inflammatory Bowel Disease

Keywords

pediatric gastrointestinal endoscopy

Outcome Measures

Primary Outcomes (3)

• Diagnostic yield of gastrointestinal 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

  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

  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 Outcomes (3)

• Types and frequencies of gastrointestinal disorders diagnosed by endoscopy

  Within 30 days after endoscopy.

• Safety and complication rates of pediatric endoscopy

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

• change in awareness among healthcare providers

  Up to 6 months from start of study.

Interventions

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.

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Endoscopic Centre at Assiut University Children Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (6)

• 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.

  PMID: 30058633 RESULT

• 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.

  PMID: 35280448 RESULT

• 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.

  PMID: 27617420 RESULT

• 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.

  PMID: 34778118 RESULT

• 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.

  PMID: 39489574 RESULT

• 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.

  PMID: 20562722 RESULT

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Deglutition Disorders; Failure to Thrive

Interventions

Endoscopy, Gastrointestinal

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Khalid Abd elaziz, MD

  Assiut University, Faculty of Medicine, Children Hospital

  STUDY DIRECTOR

• rehab ibrahim, MD

  Assiut University, Faculty of Medicine, Children Hospital

  STUDY DIRECTOR

Central Study Contacts

Aml Shaban, MBBS

CONTACT

+201066154318; amaal.17305794@med.aun.edu.eg

Rehab Ibrahim, MD

CONTACT

+20 10 09272624

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Pediatrics, Assiut University Children's Hospital

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)