Standard Treatments of Very-early Stage Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728193
• Other study ID #: 2012ZX10002016003001
• Status: Completed
• Phase: N/A
• First received: March 28, 2016
• Last updated: March 30, 2016
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma

2. Tumor diameter<2cm

3. Child-Pugh class A liver function

4. Without major organ dysfunction

5. male or female patients > 18 years and <=70 years of age

6. Voluntary participation in this clinical trial

Exclusion Criteria:

1. Other anticancer treatment before therapy

2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer

3. Patients with other diseases that may affect the treatment of this treatment

4. History of other malignant tumors

5. Patients who are participating in other clinical trials

6. Pregnant, lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Very-early Stage

Intervention

Procedure:
• RFA

• MWV

• PEI
Percutaneous ethanol injection

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Hepatocellular Carcinoma will recurrence in 3 years	3 years	Yes
Primary	Death		3 years	Yes