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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041630
Receipt No. R000047515
Scientific Title Efficacy of special ultrasonography examination focusing on the pancreas for early detection of pancreatic cancer
Date of disclosure of the study information 2020/09/01
Last modified on 2020/09/01

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Basic information
Public title Efficacy of special ultrasonography examination focusing on the pancreas for early detection of pancreatic cancer
Acronym Efficacy of special pancreatic US for early detection of pancreatic cancer
Scientific Title Efficacy of special ultrasonography examination focusing on the pancreas for early detection of pancreatic cancer
Scientific Title:Acronym Efficacy of special pancreatic US for early detection of pancreatic cancer
Region
Japan

Condition
Condition main pancreatic duct dilatation and/or the presence of pancreatic cysts
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of periodic surveillance with special pancreatic US for early detection of pancreatic cancer in the patients with main pancreatic duct dilatation and/or the presence of pancreatic cysts.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cumulative Incidence of neoplastic progression and the ratio of early detection in patients with neoplastic progression
Key secondary outcomes Changes of imaging findings and patient characteristics during surveillance, factors associated with early detection of neoplastic progression, The reasons and rates of detailed examinations such as ERCP and EUS-FNA, overall survival time in the patients with neoplastic progression, the rate of recurrence and recurrence-free survival time in the patients who undergo pancreatectomy.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 To perform a special ultrasound examination focusing on the pancreas (special pancreatic US) every 6 months and perform Magnetic Resonance Imaging (MRI) once a year.
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
35 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The patients who satisfy one of the following conditions are included.
1. Patients who have dilatation of the MPD (2.5 mm and more) and a pancreatic cyst (5 mm and more).
2. Patients who have dilatation of the MPD (4 mm and more).
3. Patients who have a pancreatic cyst (20 mm and more).

If the patients who have a family history of pancreatic cancer in first-degree relatives, it is allowed to participate in the study in the cases where MPD dilatation (2.5 mm and more) or a pancreatic cyst (5 mm and more) is detected.
Key exclusion criteria 1. Pancreas is not clearly visualized by abdominal ultrasound.
2. Patients who have active or recent malignancies of other organs.
3. Severe comorbidities (such as renal failure, liver failure, heart failure).
4. Difficulty in MRI imaging.
5. Chronic pancreatitis is strongly suspected.
6. Patients who are diagnosed as high-risk stigmata according to the updated 2017 international guidelines on IPMN of the pancreas.
7. Patients who are diagnosed as other pancreatic cystic diseases (such as serious cystic neoplasm and mucinous cystic neoplasm).
8. Pregnant women or women of childbearing potential.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Ikezawa
Organization Osaka International Cancer Institute
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 541-8567
Address 3-1-69, Otemae, Chuo-ku
TEL 0669451181
Email ikezawa-ke@mc.pref.osaka.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Ikezawa
Organization Osaka International Cancer Institute
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 541-8567
Address 3-1-69, Otemae, Chuo-ku, Osaka
TEL 0669451181
Homepage URL
Email ikezawa-ke@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Osaka International Cancer Institute
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 Institutional Review board of Osaka International Cancer Institute
Address 3-1-69, Otemae, Chuo-ku, Osaka
Tel 06-6945-1181
Email rinri01@opho.jp

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
2020 Year 09 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 04 Month 28 Day
Date of IRB
2020 Year 05 Month 12 Day
Anticipated trial start date
2020 Year 05 Month 26 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 01 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047515

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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