Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT06031402
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2023-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 368}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2023-08-30', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The failure to control bleeding after admissions', 'timeFrame': 'within 5 days admission', 'description': 'Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.'}, {'measure': '6-week rebleeding', 'timeFrame': '6-week', 'description': 'Rebleeding is defined as new onset of hematemesis or melena after successful treatment.'}], 'secondaryOutcomes': [{'measure': '6-week all-cause mortality', 'timeFrame': '6-week', 'description': 'Death.'}, {'measure': 'Adverse events', 'timeFrame': 'up to 6 weeks', 'description': 'Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver cirrhosis', 'variceal bleeding', 'gastrointestinal bleeding', 'endoscopy', 'survival', 'randomized controlled trial'], 'conditions': ['Acute Upper Gastrointestinal Bleeding', 'Acute Variceal Bleeding']}, 'referencesModule': {'references': [{'pmid': '35048654', 'type': 'BACKGROUND', 'citation': 'Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282.'}, {'pmid': '25785053', 'type': 'BACKGROUND', 'citation': 'Peng Y, Qi X, Dai J, Li H, Guo X. Child-Pugh versus MELD score for predicting the in-hospital mortality of acute upper gastrointestinal bleeding in liver cirrhosis. Int J Clin Exp Med. 2015 Jan 15;8(1):751-7. eCollection 2015.'}, {'pmid': '26937922', 'type': 'BACKGROUND', 'citation': 'Peng Y, Qi X, Guo X. Child-Pugh Versus MELD Score for the Assessment of Prognosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis of Observational Studies. Medicine (Baltimore). 2016 Feb;95(8):e2877. doi: 10.1097/MD.0000000000002877.'}, {'pmid': '31524777', 'type': 'BACKGROUND', 'citation': 'Li Y, Li H, Zhu Q, Tsochatzis E, Wang R, Guo X, Qi X. Effect of acute upper gastrointestinal bleeding manifestations at admission on the in-hospital outcomes of liver cirrhosis: hematemesis versus melena without hematemesis. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1334-1341. doi: 10.1097/MEG.0000000000001524.'}, {'pmid': '39539489', 'type': 'DERIVED', 'citation': 'Qi X, Li Y, Li B, Luo X, Liu X, Zhang C, Chen M, Kong D, Wu Y, Romeiro FG, Basaranoglu M, Zhang J, Li Q, Wang R, Shao X, Guan L, Wang N, You Y, He M, Wang X, Huang J, Wu W, Li Q, Zhang M, Wang G, Zhang C, Cheng D, Zhang Q, Mei X, Sun N, Ban Y, Marcondes MB, Yamashiro FDS, Mutlu E, Zheng Z, Peng M, Xu W, Li Z, Chai L, Linghu E. Timing of endoscopy in cirrhotic patients with acute variceal bleeding: protocol of a multicenter randomized controlled trial. Therap Adv Gastroenterol. 2024 Nov 13;17:17562848241295452. doi: 10.1177/17562848241295452. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with AVB.', 'detailedDescription': 'A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture;\n2. patients with a diagnosis of liver cirrhosis based on imaging and pathology;\n3. patients and/or their relatives who sign informed consents;\n4. patients' age ≥18 years.\n\nExclusion Criteria:\n\n1. patients who have undergone endoscopy at other hospitals before admissions;\n2. patients' hemodynamics are unstable after resuscitation;\n3. patients with severe cardiovascular or cerebrovascular diseases or renal injury;\n4. patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases;\n5. patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases;\n6. patients with mental illness;\n7. pregnancy."}, 'identificationModule': {'nctId': 'NCT06031402', 'briefTitle': 'Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding', 'orgStudyIdInfo': {'id': 'XHNKKY-ENDO-AVB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early endoscopy group', 'description': 'Intervention of endoscopy is within 12 hours after admission', 'interventionNames': ['Procedure: Endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed endoscopy group', 'description': 'Intervention of endoscopy is within 12-24 hours after admission', 'interventionNames': ['Procedure: Endoscopy']}], 'interventions': [{'name': 'Endoscopy', 'type': 'PROCEDURE', 'description': 'Endoscopy', 'armGroupLabels': ['Delayed endoscopy group', 'Early endoscopy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingshun Qi, MD', 'role': 'CONTACT', 'email': 'xingshunqi@126.com', 'phone': '18909881019'}, {'name': 'Qianqian Li', 'role': 'CONTACT', 'email': '1208594776@qq.com', 'phone': '13940307473'}], 'facility': 'Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Xingshun Qi, MD', 'role': 'CONTACT', 'email': 'xingshunqi@126.com', 'phone': '18909881019'}, {'name': 'Xingshun Qi, MD', 'role': 'CONTACT', 'email': 'xingshunqi@126.com'}], 'overallOfficials': [{'name': 'Xingshun Qi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Shenyang Military Area'}, {'name': 'Yiling Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}, {'name': 'Bimin Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Nanchang University'}, {'name': 'Xuefeng Luo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}, {'name': 'Xiaofeng Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The 960th Hospital of the Chinese People's Liberation Army"}, {'name': 'Chunqing Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Provincial Hospital of Shandong First Medical University'}, {'name': 'Mingkai Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Wuhan University"}, {'name': 'Derun Kong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Anhui Medical University'}, {'name': 'Fernando G Romeiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Botucatu Medical School'}, {'name': 'Andrea Mancuso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli'}, {'name': 'Nahum Méndez-Sánchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medica Sur Clinic and Foundation'}, {'name': 'Enqiang Linghu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Medical Center of Chinese PLA General Hospital'}, {'name': 'Yunhai Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sixth People's Hospital of Shenyang'}, {'name': 'Metin Basaranoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Gastroenterology', 'investigatorFullName': 'Xingshun Qi', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}