Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-24 @ 11:35 PM
Study NCT ID:
NCT02693951
Status:
UNKNOWN
Last Update Posted:
2017-01-06
First Post:
2016-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-03-21', 'releaseDate': '2018-12-12'}], 'estimatedResultsFirstSubmitDate': '2018-12-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D005355', 'term': 'Fibrosis'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015310', 'term': 'Cefotiam'}], 'ancestors': [{'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-04', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of infection after endoscopic treatment', 'timeFrame': '1 week', 'description': 'Patients will receive body temperature, blood routine, inflammatory markers examination before and after endoscopic treatment.'}], 'secondaryOutcomes': [{'measure': 'Rebleeding rate', 'timeFrame': '2 months', 'description': 'Patients will receive an endoscopic examination after patients have been followed up for 2 months.'}, {'measure': 'Mortality rate', 'timeFrame': '2 months', 'description': 'The investigators observe the mortality events during 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastric varices', 'endoscopic injection of tissue adhesive'], 'conditions': ['Gastric Varices', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.', 'detailedDescription': 'At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:\n\n1. the prophylactic use of antibiotics group\n\n and\n2. the non-prophylactic use of antibiotics group\n\nTreatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Capable of understanding the purpose and risks of the study and informed consent to participate in the study;\n* age between 18-75 years old;\n* Diagnosis of esophageal gastric varices by gastroscopy\n* Preparation of endoscopic injection of tissue adhesive\n\nExclusion Criteria:\n\n* No esophageal gastric varices bleeding history;\n* Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;\n* The cefotiam contraindications: such as allergies, pregnancy etc;\n* Patients with the other malignant tumor except liver cancer;\n* The preoperative diagnosis of infection;\n* The large amount of ascites;\n* The acute bleeding period (\\< 5 days);\n* Patients refused to participate in the study."}, 'identificationModule': {'nctId': 'NCT02693951', 'briefTitle': 'Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CSY-LCF-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the prophylactic use of antibiotics group', 'description': 'Half an hour before endoscopic treatment, cefotiam 2.0g intravenous', 'interventionNames': ['Drug: Cefotiam']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine endoscopic examination and treatment. Antibiotics are not used before endoscopic treatment'}], 'interventions': [{'name': 'Cefotiam', 'type': 'DRUG', 'otherNames': ['HaiTiShu'], 'description': 'Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous', 'armGroupLabels': ['the prophylactic use of antibiotics group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengfeng Liu, Doctor', 'role': 'CONTACT', 'email': '09301010167@fudan.edu.cn', 'phone': '86-15201927474'}, {'name': 'Shiyao Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chengfeng Liu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jie Chen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shiyao Chen, Professor', 'role': 'CONTACT', 'email': 'chen.shiyao@zs-hospital.sh.cn', 'phone': '86-13601767310'}], 'overallOfficials': [{'name': 'Shiyao Chen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department of Gastroenterology, Zhongshan Hospital', 'investigatorFullName': 'Shiyao Chen', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-12-12', 'type': 'RELEASE'}, {'date': '2019-03-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shiyao Chen, Director of department of Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital'}}}}