Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-03-01

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.

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Detailed Description

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By enrolling patients with unresectable Gallbladder Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Gallbladder Neoplasms.

Conditions

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Gallbladder Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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IRE Group

irreversible electroporation for Unresectable Gallbladder Neoplasms

Group Type EXPERIMENTAL

Irreversible electroporation (IRE)

Intervention Type PROCEDURE

Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.

NanoKnife

Intervention Type DEVICE

Control

The patients without treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Irreversible electroporation (IRE)

Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.

Intervention Type PROCEDURE

NanoKnife

Intervention Type DEVICE

Other Intervention Names

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NanoKnife

Eligibility Criteria

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Inclusion Criteria

* Gallbladder Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes