UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of contrast-enhanced harmonic endoscopic ultrasonography for diagnosis of liver metastases of the pancreatic carcinomas: a prospective cohort study
Title of the study (Brief title)	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	Masayuki Kitano
Organization	Kinki University Faculty of Medicine
Division name	Department of gastroenterology and Hepatology
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	Masayuki Kitano
Organization	Kinki University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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