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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027602
Receipt No. 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

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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
Institute Wakayama Medical University
Institute
Department

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
URL(English) https://upload.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


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