UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027602
Receipt number R000031361
Scientific Title Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers
Date of disclosure of the study information 2017/06/10
Last modified on 2019/06/10 21:05:23

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Basic information

Public title

Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers

Acronym

Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers

Scientific Title

Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers

Scientific Title:Acronym

Usefulness of contrast-enhanced harmonic endoscopic sonography for diagnosing liver metastases of pancreatic cancers

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to assess the ability of contrast-enhanced harmonic EUS to detect liver metastases of patients with pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We conpare the diagnostic ability of contrast-enhanced harmonic EUS to detect liver metastases of patients with pancreatic cancer with that of harmonic EUS

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

Endoscopic Ultrasound Sonography

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

over 20 years old
Patients with pancreati cancer diagnosed by imaging
Patients who agree with this study
patients whose ADL is good

Key exclusion criteria

Patients for which EUS is difficult
Patinents for which insertion of endoscopy is difficult
Patinets who have severe complication of other organs
patients who do not agree with this study

Target sample size

104


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Kitano

Organization

Wakayama Medical University

Division name

Second Department of Internal Medicine

Zip code


Address

811-1 Kimiidera, Wakayama 641-0012

TEL

073-447-2300

Email

Kitano@wakayma-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junya Nuta

Organization

Wakayama Medical University

Division name

Second Department of Internal Medicine

Zip code


Address

811-1 Kimiidera, Wakayama 641-0012

TEL

073-447-2300

Homepage URL


Email

jswnq633@yahoo.co.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Wakayama Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 06 Month 10 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

No longer recruiting

Date of protocol fixation

2017 Year 05 Month 15 Day

Date of IRB

2017 Year 04 Month 07 Day

Anticipated trial start date

2017 Year 05 Month 16 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 02 Day

Last modified on

2019 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031361


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name