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

Sponsor

Shanghai University of Traditional Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02969096

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Neoplasms	Procedure: Targeted Cryoablation Therapy	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of complete tumor ablation [Up to 4 weeks post surgery]

Secondary Outcome Measures

Adverse Events [Up to 4 weeks post surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Longhua Hospital	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Shanghai University of Traditional Chinese Medicine

Investigators

Study Director: qing wu, Bachelor, Shanghai Longhua Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT02969096

Other Study ID Numbers:

AAAA

First Posted:

Nov 21, 2016

Last Update Posted:

Nov 21, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Liver Neoplasms

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Nov 21, 2016