Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:56 AM
Study NCT ID:
NCT07239934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric GI Endoscopy at Assiut University
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D005183', 'term': 'Failure to Thrive'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}], 'ancestors': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield of gastrointestinal endoscopy', 'timeFrame': 'Within 30 days after endoscopy.', 'description': 'Proportion (%) of pediatric patients in whom gastrointestinal endoscopy provides a definitive diagnosis based on endoscopic and histopathological findings.'}, {'measure': 'Distribution of clinical indications for pediatric endoscopy', 'timeFrame': 'At the time of endoscopy.', 'description': 'Proportion (%) of children undergoing endoscopy for each indication (e.g., abdominal pain, GI bleeding, chronic diarrhea).'}, {'measure': 'Correlation between clinical suspicion and confirmed diagnosis', 'timeFrame': 'Within 30 days after endoscopy.', 'description': 'Level of agreement between pre-procedure clinical suspicion and final diagnosis based on endoscopic and histopathological findings (reported as percentage concordance).'}], 'secondaryOutcomes': [{'measure': 'Types and frequencies of gastrointestinal disorders diagnosed by endoscopy', 'timeFrame': 'Within 30 days after endoscopy.', 'description': 'Frequency distribution of gastrointestinal disorders diagnosed in pediatric patients undergoing endoscopy.'}, {'measure': 'Safety and complication rates of pediatric endoscopy', 'timeFrame': 'From the time of endoscopy until 7 days post-procedure.', 'description': 'Incidence (%) of procedure-related complications (e.g., bleeding, perforation, infection).'}, {'measure': 'change in awareness among healthcare providers', 'timeFrame': 'Up to 6 months from start of study.', 'description': 'Change in awareness and knowledge about pediatric gastrointestinal endoscopy, assessed by structured questionnaire score before and after educational sessions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric gastrointestinal endoscopy'], 'conditions': ['Chronic Diarrhea', 'Persistent Vomitting', 'Gastrointestinal Bleeding', 'Dysphagia', 'Foreign Body Ingestion', 'Failure to Thrive', 'Pediatric Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '30058633', 'type': 'RESULT', 'citation': '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': '35280448', 'type': 'RESULT', 'citation': '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': '27617420', 'type': 'RESULT', 'citation': "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': '34778118', 'type': 'RESULT', 'citation': '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': '39489574', 'type': 'RESULT', 'citation': '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': '20562722', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n2. To determine which pediatric patients require endoscopy as part of the diagnostic process.\n3. 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged from 1day to 18 years undergoing diagnostic endoscopy.\n\nExclusion Criteria:\n\n* Incomplete patient data.\n* Patients undergoing follow-up procedures.'}, 'identificationModule': {'nctId': 'NCT07239934', 'briefTitle': 'Pediatric GI Endoscopy at Assiut University', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic Role of Gastrointestinal Endoscopy in Assiut University Children Hospital', 'orgStudyIdInfo': {'id': 'endoscopy in AUCH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gastrointestinal Endoscopy', 'type': 'PROCEDURE', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Endoscopic Centre at Assiut University Children Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Aml Shaban, MBBS', 'role': 'CONTACT', 'email': 'amaal.17305794@med.aun.edu.eg', 'phone': '+201066154318'}, {'name': 'Rehab Ibrahim, MD', 'role': 'CONTACT', 'phone': '+20 10 09272624'}], 'overallOfficials': [{'name': 'Khalid Abd elaziz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University, Faculty of Medicine, Children Hospital'}, {'name': 'rehab ibrahim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University, Faculty of Medicine, Children Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Resident of Pediatrics, Assiut University Children's Hospital", 'investigatorFullName': 'Aml Shaban Mohamed Farghly', 'investigatorAffiliation': 'Assiut University'}}}}