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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015096
Receipt No. R000017544
Scientific Title Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of liver metastases of the pancreatic carcinomas: a prospective cohort study
Date of disclosure of the study information 2014/09/10
Last modified on 2017/02/10

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Basic information
Public title Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of
liver metastases of the pancreatic carcinomas: a prospective cohort study
Acronym Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of
liver metastases of the pancreatic carcinomas: a prospective cohort study
Scientific Title Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of
liver metastases of the pancreatic carcinomas: a prospective cohort study
Scientific Title:Acronym Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of
liver metastases of the pancreatic carcinomas: a prospective cohort study
Region
Japan

Condition
Condition Pancreatic carcinomas
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to evaluate the utility of contrast-enhanced harmonic EUS in diagnosis of liver metastases from pancreatic carcinomas, by comparing it with conventional EUS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes To calculate ability of contrast-enhanced harmonic EUS in diagnosing liver metastases from pancreatic carcinomas.
To compare the ability of contrast-enhanced harmonic EUS in diagnosing liver metastases from pancreatic carcinomas with that of conventinal EUS.
Key secondary outcomes To compare the ability of contrast-enhanced harmonic EUS with those of MDCT, MRI and PET.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
100 years-old >
Gender Male and Female
Key inclusion criteria Pancreatic carcinoma with confirmation by imaging and pathological examinations.
Written informed consent
ECOG performance status = 0-2
Key exclusion criteria Inapropriate to perform endoscopic ultrasonography
Failure of other organs (ASA: Grade 3, 4)
Inability to obtain informed consent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Faculty of Medicine
Division name Department of gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Email m-kitano@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL 072-366-0221
Homepage URL
Email m-kitano@med.kindai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hapatology, Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2014 Year 09 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 Completed
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Conventional EUS and contrast-enhanced harmonic EUS is performed in patients with pancreatic carcinomas. CT, MRI and PET are performed in all the same patients.
Diagnostic abilities to detect liver metastases for all imaging methods are evaluated.

Management information
Registered date
2014 Year 09 Month 09 Day
Last modified on
2017 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017544

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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