Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-31 @ 5:06 PM
Study NCT ID:
NCT00725335
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2008-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of I/R Injuries by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 498}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-23', 'studyFirstSubmitDate': '2008-07-24', 'studyFirstSubmitQcDate': '2008-07-29', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '1,3,5-year'}], 'secondaryOutcomes': [{'measure': 'overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc', 'timeFrame': 'baseline~2 weeks, 5-year overall survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ischemia', 'liver cancer', 'radical excision', 'prognosis'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '22862951', 'type': 'DERIVED', 'citation': 'Xiaobin F, Shuguo Z, Jian Z, Yudong Q, Lijian L, Kuansheng M, Xiaowu L, Feng X, Dong Y, Shuguang W, Ping B, Jiahong D. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial. BMC Cancer. 2012 Aug 3;12:340. doi: 10.1186/1471-2407-12-340.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22862951', 'label': 'Protocol'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-centre prospective randomized controlled trial to explore the influence of ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the prognosis of Hepatocellular Carcinoma (HCC) patients.', 'detailedDescription': "Until now there are two popular procedures during the radical excision of primary liver cancer in our country.One is to give a pringle manoeuvre to control the operative blood loss,the other is using a combination of CUSA and Tissue-link to control the bleeding while without liver ischemia.According to the recent experimental studies in rats,we know that the ischemia and reperfusion injury may contribute to the metastasis of the tumor.In order to test the actual contribution of ischemia on human,we conduct this prospective clinical trial to compare the two popular procedures' effect on the prognosis of liver cancer patients undergoing radical excision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of resectable primary liver cancer\n* The liver function showed:Child-Pugh A，ICG-R15 \\< 20%\n* HbsAg (+)\n* tumor nodes in the liver were singular or multiple and could be radical excision\n* No preoperative anti-cancer therapy\n* Written informed consent from the patient or legal guardian prior to entering the study\n\nExclusion Criteria:\n\n* Pregnancy patients\n* With extrahepatic tumor or lymphnode metastasis\n* Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava\n* Positive marginal'}, 'identificationModule': {'nctId': 'NCT00725335', 'briefTitle': 'Effect of I/R Injuries by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'The Effect of Ischemia/Reperfusion Injuries Elicited by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Excision:A Multicenter Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SWHB001'}, 'secondaryIdInfos': [{'id': 'ISRCTN01960869', 'type': 'OTHER', 'domain': 'a organization in UK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A,non-pringle group', 'description': 'Intervention of curative resection of HCC Without pringle manoeuvre in this arm', 'interventionNames': ['Procedure: curative resection without Pringle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pringle group(B)', 'description': 'when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied.', 'interventionNames': ['Procedure: curative resection with Pringle manoeuvre']}], 'interventions': [{'name': 'curative resection without Pringle', 'type': 'PROCEDURE', 'otherNames': ['Experimental group'], 'description': 'Radical excision of liver cancer without the procedure of pringle manoeuvre', 'armGroupLabels': ['group A,non-pringle group']}, {'name': 'curative resection with Pringle manoeuvre', 'type': 'PROCEDURE', 'otherNames': ['control group'], 'description': 'curative resection liver cancer under pringle manoeuvre', 'armGroupLabels': ['pringle group(B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Institute of hepatobiliary surgery,southwest hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Dong Jiahong, Ph D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institue of hepatobiliary surgery,Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Feng xiaobin', 'investigatorFullName': 'feng xiaobin', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}