Targeted to chronic liver disease patients undergoing abdominal ultrasonography in regular intervals, diagnosed the early hepatocellular carcinoma or more than 2cm 1.0cm.
Conditions
Interventions
January 31, 2015 February 1, 2012: Registration Period , The study period: all and January 31, 2020 February 1, 2012, for a loss of phase hepatocytes EOB-MRI is less than 2cm more than 1cm, biopsy li
other sites"
it. In addition, the re-treatment of local recurrence, it is not an event unless there is a "
relapse in other regions."
If the biopsy results are benign, conducted surveillance by ultrasound every month March continues. Hepatocellular carcinoma have emerged from the place where the nodule ischemic performing MRI and dy
onset of the same site,"
with the exception as "
first case of other sites"
lever, and the trial end point. For each, treatment and follow-up is carried out in accordance with clinical practice guidelines of liver cancer.
January 31, 2015 February 1, 2012: Registration Period
first case of other sites,"
the carcinogenesis from where the "
first case of the same site,"
different cancerous nodules is
Sponsors
Gastroenterology of the university of Tokyo hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient corresponding to all the following criteria: Nodules less than 2cm or more 1) 1.0cm Case of malignant nodules is not clear, in the current clinical practice guidelines liver cancer, 2cm For those that come to the examination and treatment is recommended.; CT ; MRI abdominal ultrasonography But easy to recognize in any modality, for nodules less than 2cm, scrutiny, Adaptation to perform treatment Investigation has not been made. Nodules of low signal in phase contrast hepatocytes 2) EOB-MRI Do not allow the hypervascular nodule in the arterial phase MRI or 3) CT When showed high signal / hypervascular in the arterial phase of dynamic CT / MRI, the Scripture together with 2) above To be treated for the diagnosis of hepatocellular carcinoma a type not subject of this study.
Exclusion criteria
Exclusion criteria: Cases correspond to the following exclusion criteria at the time of registration are excluded from the scope. Cases of liver dysfunction or more points 9 Child-Pugh score Failure in patients with severe hepatic, there are reports that the rate of excretion into feces after administration of gadolinium has dropped to 6%. Patients with renal impairment than eGFR 30mL/min In patients with severe renal impairment, in patients who spoke a foreign nephrogenic systemic fibrosis after gadolinium-based contrast agent other use has been reported Patients with severe heart disease Patients with severe respiratory disease If the physician has deemed inappropriate sharing research or study investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Entry period is three years, and observation period is five years. Comparison the time to recurrence other than the treatment site, or onset naive HCC from the randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| In case of observation for the nodule according to the pathological diagnosis, compare and investigate the rate of progression to hepatocellular carcinoma and overall survival. | — |
Countries
Japan
Contacts
Public ContactRyosuke TATEISHI
The university of Tokyo hospital Gastroenterology
Outcome results
None listed