UMIN-CTR Clinical Trial

Public title

Safety and efficacy of US-guided HIFU treatment for HCC patients

Acronym

Safety and efficacy of HIFU treatment for HCC patients

Scientific Title

Safety and efficacy of US-guided HIFU treatment for HCC patients

Scientific Title:Acronym

Safety and efficacy of HIFU treatment for HCC patients

Region

Japan

Condition

hepatocellular carcinoma (HCC)

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We evaluate the safety and efficacy of HIFU treatment for hepatocellular carcinoma (HCC)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

safety

Key secondary outcomes

efficacy

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Sonications were performed using a clinical US guided ultrasound
surgery system. The Tumor Therapy System used in this study was guided using real-time ultrasonographic imaging. An HIFU imaging unit was installed on the HIFU system to enable real-time US imaging during HIFU ablation. Imaging probe was located at the center of the HIFU transducer and was mounted in a reservoir of degassed water. Therapeutic
US energy was produced using a piezoelectric ceramic transducer
with a diameter of 20 cm, a focus length of 15 cm. After the induction of suitable
anesthesia, the patient was carefully positioned either prone or on his or her right side so that the skin overlying the lesion to be treated could be easily placed in contact with the degassed
water. We checked for pain or complications and then gradually
increased the ultrasound power. The time period for one sonication was 5 s. During the focused ultrasound ablation of each section, the real-time US images obtained before and after each exposure were immediately compared to determine whether
the hyperechoic region, indicating the extent of coagulation necrosis, had covered the desired treatment area. Patients were trained to hold their breath at the point at which their entire tumor became visible when the tumor was located between the ribs or just behind the diaphragm.

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

HCC patients admitted at this hospital and signed a informed consent
1) Child-Pugh Score <9
2) Perfomance status:0-1
3) HCC is depicted by ultrasonography
4) HCC diagnosed by imagediagnosis
5)patients with <3 lesions of small HCC and <3 cm diameter
6) patients at the age of 20<

Key exclusion criteria

1) HCC is adjust intestine
2)T-Bil 3.0mg<, <PT 50%
3)bleeding tendency (<Plt 50000/mm3)
4)patients with pregnancy
5)patients with their prognosis <3 months
6)patients the doctor judged as a non-indication from the medical ormental status

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyuki Fukuda

Organization

Yokohama City University Medical Center

Division name

Gastroenterological Center

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

fukuhiro@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroyuki Fukuda

Organization

Yokohama City University Medical Center

Division name

Gastroenterological Center

Zip code

Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL

Email

fukuhiro@yokohama-cu.ac.jp

Institute

Yokohama City University Medical 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

2015

Year

01

Month

05

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

Open public recruiting

Date of protocol fixation

2011

Year

07

Month

26

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

01

Month

02

Day

Last modified on

2015

Year

01

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018638