Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-23 @ 12:22 AM
Study NCT ID:
NCT02822066
Status:
UNKNOWN
Last Update Posted:
2016-07-04
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018274', 'term': 'Electroporation'}], 'ancestors': [{'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '60 patients of refractory neoplasms in liver and pancreas with irreversible electroporation-related effectivity as assessed by MRI', 'timeFrame': 'up to 24 months'}]}, 'conditionsModule': {'keywords': ['Effectivity', 'safety', 'irreversible electroporation', 'liver', 'pancreas'], 'conditions': ['Refractory Neoplasms']}, 'referencesModule': {'references': [{'pmid': '26777402', 'type': 'RESULT', 'citation': 'Dollinger M, Zeman F, Niessen C, Lang SA, Beyer LP, Muller M, Stroszczynski C, Wiggermann P. Bile Duct Injury after Irreversible Electroporation of Hepatic Malignancies: Evaluation of MR Imaging Findings and Laboratory Values. J Vasc Interv Radiol. 2016 Jan;27(1):96-103. doi: 10.1016/j.jvir.2015.10.002.'}, {'pmid': '26365543', 'type': 'RESULT', 'citation': 'Froud T, Venkat SR, Barbery KJ, Gunjan A, Narayanan G. Liver Function Tests Following Irreversible Electroporation of Liver Tumors: Experience in 174 Procedures. Tech Vasc Interv Radiol. 2015 Sep;18(3):140-6. doi: 10.1053/j.tvir.2015.06.004. Epub 2015 Jun 18.'}, {'pmid': '24861662', 'type': 'RESULT', 'citation': 'Hosein PJ, Echenique A, Loaiza-Bonilla A, Froud T, Barbery K, Rocha Lima CM, Yrizarry JM, Narayanan G. Percutaneous irreversible electroporation for the treatment of colorectal cancer liver metastases with a proposal for a new response evaluation system. J Vasc Interv Radiol. 2014 Aug;25(8):1233-1239.e2. doi: 10.1016/j.jvir.2014.04.007. Epub 2014 May 24.'}, {'pmid': '26118600', 'type': 'RESULT', 'citation': 'Belfiore MP, Ronza FM, Romano F, Ianniello GP, De Lucia G, Gallo C, Marsicano C, Di Gennaro TL, Belfiore G. Percutaneous CT-guided irreversible electroporation followed by chemotherapy as a novel neoadjuvant protocol in locally advanced pancreatic cancer: Our preliminary experience. Int J Surg. 2015 Sep;21 Suppl 1:S34-9. doi: 10.1016/j.ijsu.2015.06.049. Epub 2015 Jun 25.'}, {'pmid': '26774149', 'type': 'RESULT', 'citation': 'Lambert L, Horejs J, Krska Z, Hoskovec D, Petruzelka L, Krechler T, Kriz P, Briza J. Treatment of locally advanced pancreatic cancer by percutaneous and intraoperative irreversible electroporation: general hospital cancer center experience. Neoplasma. 2016;63(2):269-73. doi: 10.4149/213_150611N326.'}, {'pmid': '25765775', 'type': 'RESULT', 'citation': "Paiella S, Butturini G, Frigerio I, Salvia R, Armatura G, Bacchion M, Fontana M, D'Onofrio M, Martone E, Bassi C. Safety and feasibility of Irreversible Electroporation (IRE) in patients with locally advanced pancreatic cancer: results of a prospective study. Dig Surg. 2015;32(2):90-7. doi: 10.1159/000375323. Epub 2015 Feb 28."}, {'pmid': '31410175', 'type': 'DERIVED', 'citation': 'Jiang T, Zhao Q, Tian G, Chen X, Wu L. Irreversible electroporation ablation of end-stage metastatic retroperitoneal lesions: Report on three cases and literature review. Exp Ther Med. 2019 Sep;18(3):2243-2249. doi: 10.3892/etm.2019.7780. Epub 2019 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'The pupose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery.\n2. Patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery.\n\nExclusion Criteria:\n\nPatients with:\n\n1. Metal in the body\n2. ChildPugh ≥ 3\n3. Long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate\n4. Poor cardiac or renal function with intolerant surgery or anesthesia.'}, 'identificationModule': {'nctId': 'NCT02822066', 'briefTitle': 'Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'orgStudyIdInfo': {'id': 'LA-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IRE for refractory neoplasms in liver and pancreas', 'description': 'To evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.', 'interventionNames': ['Procedure: Electroporation']}], 'interventions': [{'name': 'Electroporation', 'type': 'PROCEDURE', 'description': 'Effectivity and safety of irreversible electroporation for refractory neoplasms in liver and pancreas', 'armGroupLabels': ['IRE for refractory neoplasms in liver and pancreas']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': "Tian'an Jiang, Phd", 'role': 'CONTACT', 'email': 'tiananjiang@126.com', 'phone': '+86 18857127666'}, {'name': 'Guo Tian, Master', 'role': 'CONTACT', 'email': '871035504@qq.com', 'phone': '+86 13600529967'}], 'facility': 'The First Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': "Tian'an Jiang, Phd", 'role': 'CONTACT', 'email': 'tiananjiang@126.com', 'phone': '+86 18857127666'}, {'name': 'Guo Tian, Master', 'role': 'CONTACT', 'email': '871035504@qq.com', 'phone': '+86 13600529967'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}