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Standard Treatments of Very-early Stage Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728193
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Very-early Stage Procedure: RFA Procedure: MWV Procedure: PEI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: RFA
Radiofrequency ablation
Procedure: RFA
Experimental: MWV
Microwave ablation
Procedure: MWV
Other Name: Microwave ablation

Experimental: PEI
Percutaneous ethanol injection
Procedure: PEI
Percutaneous ethanol injection




Primary Outcome Measures :
  1. Recurrence [ Time Frame: 3 years ]
    Hepatocellular Carcinoma will recurrence in 3 years

  2. Death [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728193


Locations
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China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
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Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT02728193    
Other Study ID Numbers: 2012ZX10002016003001
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
treatments
hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases