Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas

NCT ID: NCT02822066

Last Updated: 2016-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Refractory Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IRE for refractory neoplasms in liver and pancreas

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.

Group Type EXPERIMENTAL

Electroporation

Intervention Type PROCEDURE

Effectivity and safety of irreversible electroporation for refractory neoplasms in liver and pancreas

Interventions

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Electroporation

Effectivity and safety of irreversible electroporation for refractory neoplasms in liver and pancreas

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery.
2. Patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery.

Exclusion Criteria

Patients with:

1. Metal in the body
2. ChildPugh ≥ 3
3. Long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate
4. Poor cardiac or renal function with intolerant surgery or anesthesia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tian'an Jiang, Phd

Role: CONTACT

+86 18857127666

Guo Tian, Master

Role: CONTACT

+86 13600529967

Facility Contacts

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Tian'an Jiang, Phd

Role: primary

+86 18857127666

Guo Tian, Master

Role: backup

+86 13600529967

References

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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.

Reference Type RESULT
PMID: 26777402 (View on PubMed)

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.

Reference Type RESULT
PMID: 26365543 (View on PubMed)

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.

Reference Type RESULT
PMID: 24861662 (View on PubMed)

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.

Reference Type RESULT
PMID: 26118600 (View on PubMed)

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.

Reference Type RESULT
PMID: 26774149 (View on PubMed)

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.

Reference Type RESULT
PMID: 25765775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31410175 (View on PubMed)

Other Identifiers

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LA-003

Identifier Type: -

Identifier Source: org_study_id

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