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Not yet recruitingNCT07239934Updated Nov 20, 2025

Pediatric GI Endoscopy at Assiut University

An observational study in Chronic Diarrhea, Persistent Vomitting and Gastrointestinal Bleeding, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Ages
1 Day to 18 Years
Sex
All
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Study summary

  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.
Read the 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.

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Conditions studied

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

Keywords

  • pediatric gastrointestinal endoscopy
03

In context

Gastrointestinal Hemorrhage

338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.

This study's planned enrollment of 150 is below the median of 176 across 117 observational studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Incomplete patient data.
  • Patients undergoing follow-up procedures.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • ProcedureGastrointestinal Endoscopy

    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.

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What researchers measure

Primary outcomes

  1. Diagnostic yield of gastrointestinal endoscopy

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

    Time frame: Within 30 days after endoscopy.

  2. Distribution of clinical indications for pediatric endoscopy

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

    Time frame: At the time of endoscopy.

  3. 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).

    Time frame: Within 30 days after endoscopy.

Secondary outcomes

  1. Types and frequencies of gastrointestinal disorders diagnosed by endoscopy

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

    Time frame: Within 30 days after endoscopy.

  2. Safety and complication rates of pediatric endoscopy

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

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

  3. change in awareness among healthcare providers

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

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

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Study locations

1 site
  • Endoscopic Centre at Assiut University Children Hospital
    Asyut, Asyut Governorate 71515, Egypt
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References and documents

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. PubMed 30058633 ↗
  • 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. PubMed 35280448 ↗
  • 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. PubMed 27617420 ↗
  • 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. PubMed 34778118 ↗
  • 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. PubMed 39489574 ↗
  • 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. PubMed 20562722 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07239934
Lead sponsor
Assiut University
Responsible party
Aml Shaban Mohamed Farghly (Resident of Pediatrics, Assiut University Children's Hospital, Assiut University) — Principal investigator
First posted
Nov 20, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Nov 20, 2025

Study contacts

Aml Shaban, MBBS
Contact
amaal.17305794@med.aun.edu.eg
+201066154318
Rehab Ibrahim, MD
Contact
+20 10 09272624
Khalid Abd elaziz, MD
study director · Assiut University, Faculty of Medicine, Children Hospital
rehab ibrahim, MD
study director · Assiut University, Faculty of Medicine, Children Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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