The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma

March 29, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma After Hepatectomy: a Randomized Controlled Trial

Before the surgery, the investigators predict the risk of microvascular invasion (MVI) presence for the early-stage hepatocellular carcinoma according to the nomogram the investigators have created. Patients with a high risk of microvascular invasion were randomly chose to give the treatment of a wide resection margin, which establish an individualized anti-recurrence program based on the high-grade evidence-based medicine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Although liver resection is still the first line of treatment for hepatocellular carcinoma (HCC) presently, 5-year overall recurrence rates > 70%, the same with early-stage hepatocellular carcinoma, for some studies reported the rates > 40%. Recurrence is also the first cause of death in these patients, so recurrence is the most important factors affecting surgical results of HCC. For the precaution of cancer recurrence, there are no proven techniques for clinical reference at present.

For now, there has been many controversies on the impact about the width of liver resection margin on curative effect. Poon has proven that there is no significant difference in recurrence rate between resection margin > 1cm and resection margin < 1cm. However, Shi et al published a randomized controlled trial: for patients with a solitary tumor, resection margin > 2cm can reduce the recurrence rate after hepatectomy. This is also the only randomized clinical trial study which proves increaseing resection margin will benefit the clinical results at present. A meta analysis consist of 18 studies proves that whether the resection margin has a relationship with a benefit clinical result still needs a further verification.

On the other hand, because microvascular invasion (MVI) is the direct evidence of the micro metastasis in hepatocellular carcinoma, it will decrease recurrence rate for the patients with a high MVI risk, if the investigators increase the resection margin width during the surgery? Shanghai Eastern Hepatobiliary Surgery Hospital which the investigators affiliated with had ever conducted a retrospective analysis on consecutive 3263 patients with HCC hepatectomy, the results indicated that a wide resection margin（≥1cm）can benefit those patients with microvascular invasion , nevertheless, the benefit will not present if patients are without microvascular invasion.

Further and better proofs still needs to approval this consequence, of course. In the past，another study of the ours, published online in the Journal of the American Medical Association Surgery, established a nomogram to predict the presence of microvascular invasion in the early-stage hepatocellular carcinoma, it will efficiently predict the occurrence of microvascular invasion in the hepatocellular carcinoma (HCC) fulfilled the Milan criteria. In consideration of the above basis, the investigators will implement a randomized controlled trial to certificate whether it could really reduce the recurrence rate after liver resection for participants with a high MVI risk during the surgery, if the method participants chose is a wide resection margin.

Study Type

Interventional

Enrollment (Anticipated)

194

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
        • Recruiting
        • Eastern hepatobilliary surgery hospital
        • Contact:

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients > 18 years and <=70 years of age.
  • Diagnosed with HCC according to the criteria of American Association for the Study of Liver Diseases (AASLD).
  • Fulfill the Milan criteria.
  • High-risk of microvascular invasion (MVI).
  • Nomogram score >200.
  • Performance status score is 0-1 before the surgery.
  • Without or mild liver cirrhosis and the liver function is Child A class.
  • Without any other treatments such as TACE、PEI、PRFA before the surgery.

Exclusion Criteria:

  • Patients with macro tumor thrombus or extrahepatic metastasis.
  • Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
  • Subjects accepting other trial drugs or participating in other clinical trials.
  • Patients refuse to join our trial.
  • Female with pregnancy or during the lactation period.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wide resection margin >1cm
Surgical removal of lesions choosing the method of wide resection margin >1cm
Procedure: Wide resection margin >1cm
Surgical removal of lesions choosing the method of wide resection margin >1cm
Active Comparator: Narrow resection margin <1cm
Surgical removal of lesions choosing the method of narrow resection margin <1cm
Procedure: Narrow resection margin <1cm
Surgical removal of lesions choosing the method of wide resection margin <1cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rates of each group
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence rate of recurrence of each group
Time Frame: 3 years
3 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: Shen Feng, MD, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

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

August 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHLRM-2015-8-10

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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