UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033250
Receipt number R000037755
Scientific Title Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography
Date of disclosure of the study information 2018/07/03
Last modified on 2019/06/17 21:29:33

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Basic information

Public title

Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography

Acronym

Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography

Scientific Title

Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography

Scientific Title:Acronym

Single-center, prospective comparative study for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparative for detection ability of hepatocellular carcinoma between abdominal ultrasonography and endoscopic ultrasonography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Difference of detection rate of hepatocellular carcinoma between contrast-enhanced abdominal ultrasonography and contrast-enhanced endoscopic ultrasonography

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Abdominal ultrasonography (including contrast-enhanced abdominal ultrasonography) 1 time.
Endoscopic ultrasonography (including contrast-enhanced endoscopic ultrasonography) 1 time.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Diagnosed with hepatocellular carcinoma using contrast-enhanced CT and/or Gd-EOB-MRI.
Within 3 tumors.
Informed consent must be obtained from patients themselves.
Eastern Cooperative Oncology Group performance status 0-2.

Key exclusion criteria

Difficult to endoscopic ultrasonography.
Difficult to gastrointestinal endoscopy.
Presence of esophageal varices with F2, F3 and/or red color sign.
Presence of sever organopathy.
Difficult to obtain informed consent.
Ineligible cases are judged by researchers.

Target sample size

147


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Kitano

Organization

Wakayama Medical University

Division name

Second Department of Internal Medicine

Zip code

641-0012

Address

811-1 Kimiidera, Wakayama, Wakayama Prefecture

TEL

+81-73-447-2300

Email

kitano@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Shimizu

Organization

Wakayama Medical University

Division name

Second Department of Internal Medicine

Zip code

641-0012

Address

811-1 Kimiidera, Wakayama, Wakayama Prefecture

TEL

+81-73-447-2300

Homepage URL


Email

rshimizu@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Wakayama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee of Wakayama Medical University

Address

811-1 Kimiidera, Wakayama

Tel

0734472300

Email

wa-rinri@wakayama-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2018 Year 04 Month 27 Day

Date of IRB

2018 Year 07 Month 17 Day

Anticipated trial start date

2018 Year 07 Month 18 Day

Last follow-up date

2023 Year 04 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 02 Day

Last modified on

2019 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037755


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name