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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013762
Receipt No. R000014014
Scientific Title A randomized prospective study using secretin-enhanced pancreatic juice cytology in the diagnosis of pancreatic cancer.
Date of disclosure of the study information 2014/04/21
Last modified on 2014/04/18

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Basic information
Public title A randomized prospective study using secretin-enhanced pancreatic juice cytology in the diagnosis of pancreatic cancer.
Acronym The effect of secretin-enhanced pancreatic juice cytology
Scientific Title A randomized prospective study using secretin-enhanced pancreatic juice cytology in the diagnosis of pancreatic cancer.
Scientific Title:Acronym The effect of secretin-enhanced pancreatic juice cytology
Region
Japan

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

Objectives
Narrative objectives1 To determine effectiveness of Secretin for diagnosis of pancreatic cancer with the cytology of pancreatic juice
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome measurement is accuracy of cytology of pancreatic juice
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Administration of Secretin
Interventions/Control_2 Non-administration of Secretin
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients suspected of pancreatic cancer reffered for ERCP
Key exclusion criteria 1. Patients with acute pancreatitis
2. Patients with allergy for secretin
3. Patients unable to understand and sign informed consent
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyasu Fukutake
Organization Osaka Medical Center for Cancer and Cardiovascular Disease
Division name Department of Hepatobiliary Pancreatic Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka, Japan
TEL 06-6972-1181
Email fukutake-no@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyasu Fukutake
Organization Osaka Medical Center for Cancer and Cardiovascular Disease
Division name Department of Hepatobiliary Pancreatic Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email fukutake-no@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Disease
Institute
Department

Funding Source
Organization None
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
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 04 Month 21 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 18 Day
Last modified on
2014 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014014

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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