Chronic DiarrheaNCT07239934
Pediatric GI Endoscopy at Assiut University
An observational study of Chronic Diarrhea and Persistent Vomitting, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Chronic Diarrhea, Persistent Vomitting, Gastrointestinal Bleeding
- What is being tested?
- Gastrointestinal Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Children aged from 1day to 18 years undergoing diagnostic endoscopy.
Who cannot join
- Incomplete patient data.
- Patients undergoing follow-up procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rehab Ibrahim, MD contact
Egypt1 site
Endoscopic Centre at Assiut University Children Hospital
Asyut, Asyut Governorate, 71515
About this study
Official title: 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.
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.
- Conditions
- Chronic Diarrhea, Persistent Vomitting, Gastrointestinal Bleeding, Dysphagia, Foreign Body Ingestion, Failure to Thrive
- Being tested
- Gastrointestinal Endoscopy
- Keywords
- pediatric gastrointestinal endoscopy
- Medical subject headings
- Gastrointestinal Hemorrhage, Deglutition Disorders, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrointestinal EndoscopyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of gastrointestinal endoscopy
Proportion (%) of pediatric patients in whom gastrointestinal endoscopy provides a definitive diagnosis based on endoscopic and histopathological findings.
Measured: 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).
Measured: 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).
Measured: Within 30 days after endoscopy.
Secondary outcomes (3)
Types and frequencies of gastrointestinal disorders diagnosed by endoscopy
Frequency distribution of gastrointestinal disorders diagnosed in pediatric patients undergoing endoscopy.
Measured: Within 30 days after endoscopy.
Safety and complication rates of pediatric endoscopy
Incidence (%) of procedure-related complications (e.g., bleeding, perforation, infection).
Measured: From the time of endoscopy until 7 days post-procedure.
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.
Measured: Up to 6 months from start of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic DiarrheaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Shaban Mohamed Farghly, Assiut University
- Investigators
- Khalid Abd elaziz, MD, Study director, Assiut University, Faculty of Medicine, Children Hospitalrehab ibrahim, MD, Study director, Assiut University, Faculty of Medicine, Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239934
- Sponsor's protocol ID
- endoscopy in AUCH
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30058633Schluckebier 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 35280448Tringali 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 27617420Fachler 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 34778118Ngo 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 39489574Franciosi 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Role of Gastrointestinal Endoscopy in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07239934
- Acronym / sponsor ID
- endoscopy in AUCH
- Conditions
- Chronic Diarrhea, Persistent Vomitting, Gastrointestinal Bleeding, Dysphagia, Foreign Body Ingestion, Failure to Thrive
- Keywords
- pediatric gastrointestinal endoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Children aged from 1day to 18 years undergoing diagnostic endoscopy.
Key exclusion criteria (2 listed)
- Incomplete patient data.
- Patients undergoing follow-up procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrointestinal EndoscopyChildren 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. | Procedure or surgery | – |
Primary outcome
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.
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).
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).
3 secondary outcomes
Types and frequencies of gastrointestinal disorders diagnosed by endoscopy
Time frame: Within 30 days after endoscopy.
Safety and complication rates of pediatric endoscopy
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 30058633Bohara 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.
- Results publication: PubMed 35280448Schluckebier 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.
- Results publication: PubMed 27617420Tringali 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.
- Results publication: PubMed 34778118Fachler 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.
- Results publication: PubMed 39489574Ngo 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.
- Results publication: PubMed 20562722Franciosi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rehab Ibrahim, MD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diarrhea and Persistent Vomitting, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aml Shaban, MBBS (+201066154318, amaal.17305794@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of gastrointestinal endoscopy (time frame: Within 30 days after endoscopy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07239934, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.