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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PRFA or PMCT
surgery
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, surgery

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern Hepatobiliary Surgery Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Procedure/Surgery

Procedure

Arm Description

surgery

PRFA or PMCT

Outcomes

Primary Outcome Measures

Overall survival rate

Secondary Outcome Measures

non-tumor life span, intra-liver recurrence rate, metastasis rate

Full Information

First Posted
January 6, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00822562
Brief Title
Research on Surgery and Micro-Invasive Treatment in Recurrent Primary Liver Cancer
Official Title
Research on Surgery and Micro-Invasive Treatment in Recurrent Primary Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procedure/Surgery
Arm Type
Active Comparator
Arm Description
surgery
Arm Title
Procedure
Arm Type
Experimental
Arm Description
PRFA or PMCT
Intervention Type
Other
Intervention Name(s)
PRFA or PMCT
Intervention Description
PRFA or PMCT 30-35W for 10-15minutes one cycle,three cycles
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
only surgery
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
two years
Secondary Outcome Measure Information:
Title
non-tumor life span, intra-liver recurrence rate, metastasis rate
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20~60 years old; diagnosed HCC pathologically, and confirmed recurrent HCC through ultrasonic B, CT, MRI or DSA test; has a good condition in vital organs such as heart, lung, and kidney; has a good liver function: Child A level, or nearly A level after hepatoprotection treatment; 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; without jaundice (not including jaundice in the bile ducts), without ascites or extensive metastasis outside the liver; without invasion to portal vein. Exclusion Criteria: subjects refuse to participate in this study; subjects cannot be followed up regularly; subjects with severe heart, lung, kidney diseases; subjects with liver CP level B or C, and serum creatinine ≥2×ULN; subjects with severe bone marrow depression, such as neutrophil counting is lower than 1.5 × 109.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Shen, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31774468
Citation
Xia Y, Li J, Liu G, Wang K, Qian G, Lu Z, Yang T, Yan Z, Lei Z, Si A, Wan X, Zhang H, Gao C, Cheng Z, Pawlik TM, Wang H, Lau WY, Wu M, Shen F. Long-term Effects of Repeat Hepatectomy vs Percutaneous Radiofrequency Ablation Among Patients With Recurrent Hepatocellular Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2020 Feb 1;6(2):255-263. doi: 10.1001/jamaoncol.2019.4477. Erratum In: JAMA Oncol. 2020 Jan 9;:
Results Reference
derived

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

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