NCT02525965

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
194

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

August 10, 2015

Last Update Submit

March 29, 2016

Conditions

Hepatocellular Carcinoma

Keywords

Wide resection marginRecurrenceEarly-stage hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival rates of each group

    3 years

Secondary Outcomes (1)

  • Occurrence rate of recurrence of each group

    3 years

Study Arms (2)

Wide resection margin >1cm

EXPERIMENTAL

Surgical removal of lesions choosing the method of wide resection margin \>1cm

Procedure: Wide resection margin >1cm

Narrow resection margin <1cm

ACTIVE COMPARATOR

Surgical removal of lesions choosing the method of narrow resection margin \<1cm

Procedure: Narrow resection margin <1cm

Interventions

Wide resection margin >1cmPROCEDURE

Surgical removal of lesions choosing the method of wide resection margin \>1cm

Wide resection margin >1cm
Narrow resection margin <1cmPROCEDURE

Surgical removal of lesions choosing the method of wide resection margin \<1cm

Narrow resection margin <1cm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shen Feng, MD

    Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

    STUDY CHAIR

Central Study Contacts

Shen Feng, MD

CONTACT

0086-021-25070805shenfengdfgd@yahoo.com.cn

Wu Dong, MD

CONTACT

0086-021-25070765wuyuz@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 18, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(1)