Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT06092593
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2023-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Upper Endoscopy in Ulcerative Colitis Patients in Assiut University
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005773', 'term': 'Gastroscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients', 'timeFrame': 'Baseline', 'description': 'The relationship between ulcerative colitis patients and upper gastrointestinal tract lesions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Upper Gastrointestinal Disorder']}, 'referencesModule': {'references': [{'pmid': '34168401', 'type': 'BACKGROUND', 'citation': 'Sun Y, Zhang Z, Zheng CQ, Sang LX. Mucosal lesions of the upper gastrointestinal tract in patients with ulcerative colitis: A review. World J Gastroenterol. 2021 Jun 14;27(22):2963-2978. doi: 10.3748/wjg.v27.i22.2963.'}, {'pmid': '29674758', 'type': 'BACKGROUND', 'citation': 'Kato R, Iwamuro M, Hiraoka S, Takashima S, Inokuchi T, Takahara M, Kondo Y, Tanaka T, Okada H. Evaluation of the Upper Gastrointestinal Tract in Ulcerative Colitis Patients. Acta Med Okayama. 2018 Apr;72(2):105-113. doi: 10.18926/AMO/55850.'}, {'pmid': '28991840', 'type': 'BACKGROUND', 'citation': 'Queliza K, Ihekweazu FD, Schady D, Jensen C, Kellermayer R. Granulomatous Upper Gastrointestinal Inflammation in Pediatric Ulcerative Colitis. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):620-623. doi: 10.1097/MPG.0000000000001771.'}]}, 'descriptionModule': {'briefSummary': 'Aim of study:\n\nPrimary Outcomes:\n\nPatients with ulcerative colitis-associated upper gas- trointestinal inflammation may require specific treat- ment for the gastroduodenal lesions. Hence, recogni- tion and detection of the upper gastrointestinal lesions are important. Here we describe 2 cases of ulcerative colitis and summarize the results of our investigation of the prevalence of upper gastrointestinal involvement detected by esophagogastroduodenoscopy. We also analyzed the macroscopic and microscopic features of the upper gastrointestinal lesions\n\nSecondary Outcomes:\n\ncorrect and timely treatment of upprt GIT lesions in UC .', 'detailedDescription': 'Ulcerative colitis (UC) is an idiopathic, chronic, relapsing inflammatory bowel disease (IBD) occurring in the colon and rectum . The main typical symptoms of UC include frequent bowel movement, mucus pus, bloody diarrhea, abdominal pain and discomfort, urgency, weight loss, and tenesmus . Apart from these typical symptoms, emerging evidence supports that there are a variety of accompanying symptoms involving the upper gastrointestinal (UGI) tract in patients with UC upon macroscopic and microscopic analyses, such as eosinophilic esophagitis\\[9\\], gastroduodenitis, ulcers, or UGI inflammation In addition, the positive rate of UGI endoscopy in asymptomatic individuals was lower than that in symptomatic patients. The reported clinically significant UGI lesions include multiple erosions, granular changes, white spots, friable mucosa, ulcer, and purulent deposits during fibrogastroduodenoscopy (FGDS)\\[ط UGI involvement may be unnoticed by the attending physician due to the lack of the knowledge of gastroduodenal lesions, which should raise concerns during UC treatment. Furthermore, there is no established standard or criteria available for patients with UC who should undergo FGDS , because the clinical backgrounds of these patients with UC-associated UGI lesions have not been fully and exactly demonstrated. Specific management may be required for patients with UC-associated UGI lesions. Henceforth, we conducted this study with the aim of describing various UGI tract presentations in UC and their differential diagnosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cross sectionaql study will be conducted in Assuit University hospital .Adult patients diagnosed as UC by clinical date , laboratory ,colonscopy and histopathological examination will undergo :\n\nfull medical history taking : age, gender, time since the ulcerative colitis diagnosis, History of surgery for ulcerative colitis, medications , history of any upper GIT symptoms nausea , vomiting , epigastric pain , heart burn , dysphagia and hematemsis or melena .\n\ncomplete physical examination , with focus on pulse, blood pressure, body temperature and signs of extra intestinal involvement.\n\nEsophagogastro-duodenoscopy Histopathological examination of biopsies taken from any lesions', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients' age is 18 years or above.\n* Patient who are diagnosed with UC..\n* Patient who are fit to undergo upper endoscopy .\n\nExclusion Criteria:\n\n* Pediatric patients.\n* patient refuse to participate at this study\n* patient with known upper GIT disorder ."}, 'identificationModule': {'nctId': 'NCT06092593', 'briefTitle': 'Upper Endoscopy in Ulcerative Colitis Patients in Assiut University', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Upper Gastrointestinal Tract Lesions in Ulcerative Colitis Patients in Assiut University', 'orgStudyIdInfo': {'id': 'Upper endoscopy UC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Upper endoscopy', 'type': 'DEVICE', 'description': 'Evaluation of upper gastrointestinal tract lesions in ulcerative colitis patients'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gamal A Gaber, Master', 'role': 'CONTACT', 'email': 'gmalabnaser96@gmail.com', 'phone': '01126526545', 'phoneExt': '1'}, {'name': 'Muhammad Abass el masry, Professor', 'role': 'CONTACT', 'email': 'masaeed2@yahoo.com', 'phone': '+20 121 240 1707', 'phoneExt': '2'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Gamal Abdelnasser Gaber Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}