UMIN-CTR Clinical Trial

Public title

Analysis of risk factors and prognostic factors included histological status of underlying liver disease of patients undergoing curative resection or radiofrequency ablation of hepatocellular carcinoma; May hepatic steatosis correlate with the postoperative recurrence of hepatocellular carcinoma?

Acronym

Risk and Prognostic factors included hepatic steatosis of HCC

Scientific Title

Analysis of risk factors and prognostic factors included histological status of underlying liver disease of patients undergoing curative resection or radiofrequency ablation of hepatocellular carcinoma; May hepatic steatosis correlate with the postoperative recurrence of hepatocellular carcinoma?

Scientific Title:Acronym

Risk and Prognostic factors included hepatic steatosis of HCC

Region

Japan

Condition

Patients with Hepatocellular carcinoma(HCC) after curative treatment

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Recently, a correlation between liver steatosis and HCC was reported except for liver fibrosis and inflammation . Moreover,
HCC from NASH(nonalcholic steatohepatitis) seems to increases, and we mainly and prospectively observe the correlation between the risk factors of recurrence of HCC, and these histological findings such as liver steatosis, liver fibrosis, and inflammation after curative treatments of HCC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The cumulative tumor recurrence rate in patients with HCC

Key secondary outcomes

Cumulative survival rate in patients with HCC.
Risk factors of recurrence of HCC and prognostic factors(these histological findings such as liver steatosis, liver fibrosis, and inflammation, Cancer Stage, Child-Pugh,and laboratory data, etc.)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

a)HCC without prior treatments
b)Patients underwent curative resection or radiofrequency ablation therapy(RFA) of HCC. Resection was defined as curative when the entire tumor was macroscopically removed and the surgical margin was microscopically free from tumor invasion.
c)For patients with HCC the Milan criteria were applied (solitary tumor of 5 cm, or three or fewer lesions, none >3 cm without vascular invasion, or extrahepatic metastasis).

Key exclusion criteria

a)Recurred HCC
b)uncontrolled other malignancies
c)ruptured HCC
d)Operation-related death
e)Judged to be inadequate case of this clinical study for other reasons by doctors

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Yoshitaka Takuma

Organization

National Hospital Organization Iwakuni
Clinical Center

Division name

Internal Medicine

Zip code

Address

2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

National Hospital Organization IwakuniClinical Center

Division name

Internal Medicine

Zip code

Address

TEL

Homepage URL

Email

takuma@iwakuni-nh.go.jp

Institute

Department of Internal Medicine, National Hospital Organization IwakuniClinical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2004

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2004

Year

07

Month

01

Day

Last follow-up date

2015

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We mainly and prospectively observe the correlation between the risk factors of recurrence of HCC, and these histological findings such as liver steatosis, liver fibrosis, and inflammation after curative treatments of HCC.
The criteria established by Desmet et al. as follows: F0 (no fibrosis), F1 (mild fibrosis), F2 (moderate fibrosis), and F3 (severe fibrosis) are categorized noncirrhosis; and F4 (cirrhosis) is categorized cirrhosis. The degree of necroinflammatory activity is scored as A0 (no activity) A1 (mild activity), A2 (moderate activity), and A3 (severe activity). The severity of steatosis is graded by Brunt et al.
NASH(nonalcholic steatohepatitis) is diagnosed according to Matteoni et al.
Accordingly, the patients with NAFLD(nonalcoholic fatty liver desease) type 3 and type 4 are assigned to NASH.

Registered date

2008

Year

01

Month

06

Day

Last modified on

2014

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001129