Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT06214234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-19
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Patient will be enrolled in one each group without masking'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of patients present with variceal bleeding'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'in-hospital bleeding', 'timeFrame': 'One year', 'description': 'Frequency of mortality in patients with variceal bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Varices']}, 'referencesModule': {'references': [{'pmid': '35477727', 'type': 'BACKGROUND', 'citation': 'Kim J, Gong EJ, Seo M, Park JK, Lee SJ, Han KH, Kim YD, Jeong WJ, Cheon GJ, Seo HI. Timing of endoscopy in patients with upper gastrointestinal bleeding. Sci Rep. 2022 Apr 27;12(1):6833. doi: 10.1038/s41598-022-10897-3.'}]}, 'descriptionModule': {'briefSummary': 'Liver cirrhosis is a common diffuse and persistent liver disease often accompanied by portal hypertension, liver failure, upper gastrointestinal bleeding (UGIB), and other complications. The incidence rate of liver cirrhosis with UGIB is as high as 30-40%, which is related to the rupture bleeding of gastroesophageal varices (GOV), hepatogenic ulcer, portal hypertensive gastropathy, hepatic gastrointestinal failure, etc', 'detailedDescription': 'In the case of UGIB in patients with liver cirrhosis, acute peripheral circulatory failure may suddenly occur, resulting in decreased blood perfusion in liver tissues, often accompanied by clinical manifestations such as blood volume decline, melena, and haematemesis. This disease progresses rapidly, with a mortality rate of above 10% if not treated promptly\n\nTiming of endoscopy in the management of acute upper gastrointestinal bleeding (AUGIB) has been a subject of perennial debate. Despite remarkable advancements in endoscopic treatments and substantial efforts in reducing mortality, the overall in-hospital mortality rate associated with UGIB is still estimated to be 10%.\n\nSeveral studies have investigated the clinical impact of urgent (within 6 h of presentation) or early (within 12 h) endoscopy on mortality in patients with UGIB. Some studies showed no significant difference in mortality rate between urgent and elective endoscopy groups among high-risk patients with acute UGIB\n\nIn contrast, others found that urgent endoscopy was associated with a lower mortality rate in high-risk patients with acute non-variceal UGIB. Most of the previous studies included highly selected patients with non-variceal UGIB or those at a high risk. However, given that the definitive diagnosis is made after endoscopic examination, these studies may not reflect real-world clinical practice. Furthermore, it is often challenging to predict the cause of bleeding and to identify patients at high risk who require intensive care based on their symptoms and the information obtained in the emergency room'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAny patient who is above age of 18 years old and with liver cirrhosis and present with UGIB will be eligible for the study\n\nExclusion Criteria:\n\n* Patients with age less than 18 years old\n* Non-cirrhotic patients\n* Patients with hemodynamic instability\n* Patient's refusal"}, 'identificationModule': {'nctId': 'NCT06214234', 'acronym': 'Varices', 'briefTitle': 'Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Timing of Upper Endoscopy in Cirrhotic Patients With Upper Gastrointestinal Bleeding: Urgent vs. Elective Endoscopy', 'orgStudyIdInfo': {'id': 'Shadn Protocol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Early band ligation', 'description': 'Patients with liver cirrhosis present with variceal bleeding underwent band ligation within 12 hours of presentation', 'interventionNames': ['Procedure: Band ligation']}, {'type': 'OTHER', 'label': 'Delayed band ligation', 'description': 'Patients with liver cirrhosis present with variceal bleeding underwent band ligation within more than 12 hours of presentation', 'interventionNames': ['Procedure: Band ligation']}], 'interventions': [{'name': 'Band ligation', 'type': 'PROCEDURE', 'description': 'Band ligation in variceal bleeding', 'armGroupLabels': ['Delayed band ligation', 'Early band ligation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Shaden Kelany, MSc', 'role': 'CONTACT', 'email': 'shadenahmed997@gmail.com', 'phone': '01024817165', 'phoneExt': '002'}, {'name': 'Ahmed M Abu-Elfatth, MD', 'role': 'CONTACT', 'email': 'ahmed111@aun.edu.eg', 'phone': '+18677791'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Shaden Kelany, MSc', 'role': 'CONTACT', 'email': 'shadenahmed997@gmail.com', 'phone': '01024817165', 'phoneExt': '002'}, {'name': 'Ahmed M Abu-Elfatth, MD', 'role': 'CONTACT', 'email': 'ahmed111@aun.edu.eg', 'phone': '+18677791'}], 'overallOfficials': [{'name': 'Shaden Kelany, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shadn Ahmed Keilany', 'investigatorAffiliation': 'Assiut University'}}}}