UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041630 |
|---|---|
| Receipt number | 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 | 2022/12/20 13:42:40 |
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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
ikezawa-ke@oici.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
ikezawa-ke@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047515
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