Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma

NCT ID: NCT02969096

Last Updated: 2016-11-21

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

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.

Detailed Description

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A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.

Conditions

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Liver 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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Targeted Cryoablation Therapy

liver cancer patients received targeted cryoablation therapy.

Group Type EXPERIMENTAL

Targeted Cryoablation Therapy

Intervention Type PROCEDURE

A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.

Interventions

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Targeted Cryoablation Therapy

A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of liver cancer based on histology or the current accepted radiological measures.
* Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
* Life expectancy: Greater than 3 months.
* Patients' liver function is Child-pugh A or B.
* Ability to understand the study protocol and a willingness to sign a written informed consent document.
* Unable to receive operative surgery.

Exclusion Criteria

* Patients with other primary tumor except liver cancer.
* History of coagulation disorders or anemia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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qing wu, Bachelor

Role: STUDY_DIRECTOR

Shanghai Longhua Hospital

Locations

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Shanghai Longhua Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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AAAA

Identifier Type: -

Identifier Source: org_study_id