Research on Surgery and Micro-Invasive Treatment in Recurrent Primary Liver Cancer

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital
In this study, we intend to divide the subjects who have been confirmed recurrent HCC into two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio frequency. We will compare the non-tumor survival time, long-term survival rate between the two groups, summarize the merits and demerits of both groups, and try to establish a standardized therapy and treatment for the this kind of patients through prospective studies on the molecular biological difference of pathological samples between the first and second surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The recurrence and metastasis of primary liver cancer (PLC) have always been a tough problem for surgeons. Gu Hong-guang reported the five years recurrence rate in PLC subjects reached 75~100%, among which 60% were discovered within three years after surgeries, with the peak appearing at 18~24 months. According to a report delivered by Zhong-Shan Hospital, the recurrence rate of small HCC was 40%, and that of large HCC was 1.9 times of small HCC. Chen Han agreed that the recurrence rate in 1~2 years reached 71.6%, while in 2~11 years was 28.4%. With the rapid development of iconography and surgical techniques, it is possible for surgeon to resect the recurrent HCC now. In 1986, Nagasue et al. reported the excision of recurrent HCC and proved that comparing with non-surgical treatment, subjects with recurrent HCC excision got a higher survival rate. However, the excision rate of recurrent HCC has always been an arguable point. Nakajima et al. suggested the excision rate in 133 subjects was 24%, while Matsuda et al. agreed that in 91 subjects reached 44%, and Zhoo reported that in 384 subjects was 35%; Kakazu et al. insisted that in 286 subjects was 17%; Nagasue et al. said that in 290 subjects was 30%; Shoto et al. reported that in 341 subjects was 19% and Poon et al. advocated that in 244 subjects was 10%. He Sheng summarized the 1295 subjects in recent five years, and only 106 of them had the opportunities to have excision again (8.18%). Sugimachi, Minagawa et al. reported separately the 5 year survival rate in recurrent HCC subjects were 47.5% and 56.0%, which showed no significant difference with the first surgeries, but better therapeutic effects, meanwhile, third and forth surgeries could also get similar survival rate, which indicated that surgical excision is a vital treatment in recurrent HCCs. Chen Han in our hospital reported the first, third, fifth, and tenth year survival rate in 162 recurrent HCC subjects who underwent first surgical treatment were separately 96.8%, 66.7%, 43.6% and 21.8%; while that in subjects who received second surgical treatment were separately 94.7%, 44.9% and 25.0% at the first, third, and fifth year (mean survival time was 45 months, and average survival time was 54 months).

In this study, we intend to divide the subjects who have been confirmed recurrent HCC into two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio frequency. We will compare the non-tumor survival time, long-term survival rate between the two groups, summarize the merits and demerits of both groups, and try to establish a standardized therapy and treatment for the this kind of patients through prospective studies on the molecular biological difference of pathological samples between the first and second surgeries.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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, 200438
        • Eastern Hepatobiliary Surgery 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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 20~60 years old;
  2. diagnosed HCC pathologically, and confirmed recurrent HCC through ultrasonic B, CT, MRI or DSA test;
  3. has a good condition in vital organs such as heart, lung, and kidney;
  4. has a good liver function: Child A level, or nearly A level after hepatoprotection treatment;
  5. solitary small cancer focus (diameter <5cm), or the number of recurrent HCC focus is no more than three and all of them grow in the same lobe of liver;
  6. without jaundice (not including jaundice in the bile ducts), without ascites or extensive metastasis outside the liver;
  7. without invasion to portal vein.

Exclusion Criteria:

  1. subjects refuse to participate in this study;
  2. subjects cannot be followed up regularly;
  3. subjects with severe heart, lung, kidney diseases;
  4. subjects with liver CP level B or C, and serum creatinine ≥2×ULN;
  5. subjects with severe bone marrow depression, such as neutrophil counting is lower than 1.5 × 109.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Procedure/Surgery
surgery
Procedure: surgery
only surgery
Experimental: Procedure
PRFA or PMCT
Other: PRFA or PMCT
PRFA or PMCT 30-35W for 10-15minutes one cycle,three cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
non-tumor life span, intra-liver recurrence rate, metastasis rate
Time Frame: two years
two years

Collaborators and Investigators

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

Sponsor

Eastern Hepatobiliary Surgery Hospital

Investigators

  • Study Chair: Feng Shen, MD, Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBH-RCT-2008-016
  • ZD2008-016-P1

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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