Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT02563158
Status:
UNKNOWN
Last Update Posted:
2016-05-12
First Post:
2015-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2015-09-26', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum total bilirubin on postoperative day 5', 'timeFrame': '5 days', 'description': 'Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'Entire operation duration', 'description': 'Total blood loss from the incision to the closure of abdomen'}, {'measure': 'Requirement of blood transfusion', 'timeFrame': 'Entire operation duration', 'description': 'The amount of intraoperative blood transfusion'}, {'measure': 'Operative time', 'timeFrame': 'Entire operation duration', 'description': 'The time from induction of anesthesia to the closure of abdomen'}, {'measure': 'Postoperative intensive-care unit (ICU) stay', 'timeFrame': 'Duration of stay in ICU', 'description': 'Duration of stay in ICU'}, {'measure': 'Hospital stay', 'timeFrame': 'Duration of hospital stay', 'description': 'Duration of hospital stay'}, {'measure': 'Total hospital expenditure', 'timeFrame': 'Duration of hospital stay', 'description': 'Total costs during hospital stay'}, {'measure': 'Perioperative systemic inflammatory response', 'timeFrame': 'an expected average of 7 days', 'description': 'Perioperative systemic inflammatory response is characterized by elevated serum level of tumor necrosis factor-α (TNF-α), interleukins (IL)-1α, 2, 6, 8 and 10, procalcitonin (PCT) and C-reactive protein (CRP) at different time points.'}, {'measure': 'Postoperative morbi-mortality', 'timeFrame': 'an expected average of 12 days in hospital', 'description': 'Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality'}, {'measure': 'Long-term oncologic outcomes', 'timeFrame': '5 years after operation', 'description': '1, 3, 5-year tumor recurrence rate'}, {'measure': 'Long-term survival', 'timeFrame': '5 years after operation', 'description': '1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['liver resection', 'blood inflow control', 'ischemia-reperfusion injury', 'inflammatory response', 'randomized controlled trial'], 'conditions': ['Liver Cancer', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '14762851', 'type': 'RESULT', 'citation': 'Llovet JM, Fuster J, Bruix J; Barcelona-Clinic Liver Cancer Group. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma. Liver Transpl. 2004 Feb;10(2 Suppl 1):S115-20. doi: 10.1002/lt.20034.'}, {'pmid': '20137393', 'type': 'RESULT', 'citation': 'Dong JH, Yang SZ, Duan WD, Ji WB, Cai SW, Wang J, Shi XJ, Jiang K, Xia HT, He L, Zhang WZ, Huang XQ, Huang ZQ. [Clinical application of precise liver resection techniques in patients with complicated liver space-occupying lesions]. Zhonghua Wai Ke Za Zhi. 2009 Nov 1;47(21):1610-5. Chinese.'}, {'pmid': '19094562', 'type': 'RESULT', 'citation': 'Huang ZQ, Xu LN, Yang T, Zhang WZ, Huang XQ, Liu R, Cai SW, Zhang AQ, Feng YQ, Zhou NX, Dong JH. [Liver resection: single center experiences of 2008 consecutive resections in 20 years]. Zhonghua Wai Ke Za Zhi. 2008 Sep 1;46(17):1314-21. Chinese.'}, {'pmid': '23943100', 'type': 'RESULT', 'citation': 'Dong J, Yang S, Zeng J, Cai S, Ji W, Duan W, Zhang A, Ren W, Xu Y, Tan J, Bu X, Zhang N, Wang X, Wang X, Meng X, Jiang K, Gu W, Huang Z. Precision in liver surgery. Semin Liver Dis. 2013 Aug;33(3):189-203. doi: 10.1055/s-0033-1351781. Epub 2013 Aug 13. Danish, English.'}, {'pmid': '20632273', 'type': 'RESULT', 'citation': "Sugiyama Y, Ishizaki Y, Imamura H, Sugo H, Yoshimoto J, Kawasaki S. Effects of intermittent Pringle's manoeuvre on cirrhotic compared with normal liver. Br J Surg. 2010 Jul;97(7):1062-9. doi: 10.1002/bjs.7039."}, {'pmid': '12143206', 'type': 'RESULT', 'citation': 'Kim YI, Song KE, Ryeon HK, Hwang YJ, Yun YK, Lee JW, Chun BY. Enhanced inflammatory cytokine production at ischemia/reperfusion in human liver resection. Hepatogastroenterology. 2002 Jul-Aug;49(46):1077-82.'}, {'pmid': '19300227', 'type': 'RESULT', 'citation': "Katz SC, Shia J, Liau KH, Gonen M, Ruo L, Jarnagin WR, Fong Y, D'Angelica MI, Blumgart LH, Dematteo RP. Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma. Ann Surg. 2009 Apr;249(4):617-23. doi: 10.1097/SLA.0b013e31819ed22f."}, {'pmid': '20409520', 'type': 'RESULT', 'citation': 'Fu SY, Lau WY, Li GG, Tang QH, Li AJ, Pan ZY, Huang G, Yin L, Wu MC, Lai EC, Zhou WP. A prospective randomized controlled trial to compare Pringle maneuver, hemihepatic vascular inflow occlusion, and main portal vein inflow occlusion in partial hepatectomy. Am J Surg. 2011 Jan;201(1):62-9. doi: 10.1016/j.amjsurg.2009.09.029. Epub 2010 Apr 20.'}, {'pmid': '27724929', 'type': 'DERIVED', 'citation': 'Xu Y, Chen J, Wang H, Zheng H, Feng D, Zhang A, Leng J, Duan W, Yang Z, Chen M, Shi X, Cai S, Ji W, Jiang K, Zhang W, Chen Y, Gu W, Dong J, Lu S. Perioperative and long-term outcomes of liver resection for hepatitis B virus-related hepatocellular carcinoma without versus with hepatic inflow occlusion: study protocol for a prospective randomized controlled trial. Trials. 2016 Oct 11;17(1):492. doi: 10.1186/s13063-016-1621-9.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.', 'detailedDescription': 'High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.\n\nThis study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis.\n\nThis prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;\n2. Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;\n3. Tumors located either in the left or right hemiliver;\n4. Resection extent was a hemi-hepatectomy or less;\n5. Informed consent.\n\nExclusion Criteria:\n\n1. Having comorbidity that contraindicates surgery;\n2. Participation in concurrent interventional trials with interference to this study;\n3. Eligible for laparoscopic hepatectomy;\n4. Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;\n5. Lack of compliance for treatment or future follow-up.'}, 'identificationModule': {'nctId': 'NCT02563158', 'acronym': 'OHx-NOHx', 'briefTitle': 'Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Short- and Long-term Outcomes of Liver Resection With Versus Without Hepatic Inflow Occlusion for the Hepatitis B Virus-related Hepatocellular Carcinoma: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'JFJZYY-GD-15-01'}, 'secondaryIdInfos': [{'id': 'NO. 2012BAI06B01', 'type': 'OTHER_GRANT', 'domain': 'National Key Technology R&D Program of China'}, {'id': 'NO. 2012ZX10002-017', 'type': 'OTHER_GRANT', 'domain': 'National S&T Major Project for Infectious Diseases of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Hx with hepatic inflow occlusion', 'description': 'Hepatectomy is carried out using Pringle maneuver in cycles of 15 minutes clamping + 5 minutes unclamping of the hepatoduodenal ligament.'}, {'type': 'EXPERIMENTAL', 'label': 'Hx with non-occlusion technique', 'description': 'Hepatectomy without hepatic inflow occlusion (non-occlusion technique)', 'interventionNames': ['Procedure: non-occlusion technique']}], 'interventions': [{'name': 'non-occlusion technique', 'type': 'PROCEDURE', 'otherNames': ['hepatectomy without hepatic inflow occlusion'], 'description': 'Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)', 'armGroupLabels': ['Hx with non-occlusion technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yinzhe Xu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'james_hbp@163.com', 'phone': '86-10-66936609'}, {'name': 'Shichun Lu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shichun Lu, MD, PhD', 'role': 'CONTACT', 'email': 'sclu_301@163.com', 'phone': '+86 10 68160801'}, {'name': 'Yinzhe Xu, MD, PhD', 'role': 'CONTACT', 'email': 'james_hbp@163.com', 'phone': '+1 617 818 4081'}], 'overallOfficials': [{'name': 'Shichun Lu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Hepatobiliary Surgery', 'investigatorFullName': 'Prof. Shichun Lu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}