Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 4, 2016
June 1, 2016
2.2 years
June 20, 2016
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
60 patients of refractory neoplasms in liver and pancreas with irreversible electroporation-related effectivity as assessed by MRI
up to 24 months
Study Arms (1)
IRE for refractory neoplasms in liver and pancreas
EXPERIMENTALTo 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.
Interventions
Effectivity and safety of irreversible electroporation for refractory neoplasms in liver and pancreas
Eligibility Criteria
You may qualify if:
- Patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery.
- Patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery.
You may not qualify if:
- Patients with:
- Metal in the body
- ChildPugh ≥ 3
- Long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate
- Poor cardiac or renal function with intolerant surgery or anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
Related Publications (7)
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: 26777402RESULTFroud 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: 26365543RESULTHosein 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: 24861662RESULTBelfiore 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: 26118600RESULTLambert 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: 26774149RESULTPaiella 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: 25765775RESULTJiang 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.
PMID: 31410175DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
July 4, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
July 4, 2016
Record last verified: 2016-06