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

November 17, 2016 updated by: Shanghai University of Traditional Chinese Medicine

Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Shanghai Longhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Targeted Cryoablation Therapy
liver cancer patients received targeted cryoablation therapy.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of complete tumor ablation
Time Frame: Up to 4 weeks post surgery
Up to 4 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Up to 4 weeks post surgery
Up to 4 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Investigators

  • Study Director: qing wu, Bachelor, Shanghai Longhua Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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