UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016987 |
|---|---|
| Receipt number | R000019697 |
| Scientific Title | A prospective study of the natural history of pancreatic cyst including branch duct type intraductal papillary mucinous neoplasms of the pancreas |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2019/08/05 17:59:37 |
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Basic information
Public title
A prospective study of the natural history of pancreatic cyst including branch duct type intraductal papillary mucinous neoplasms of the pancreas
Acronym
A prospective study of the natural history of pancreatic cyst including branch duct type IPMN
Scientific Title
A prospective study of the natural history of pancreatic cyst including branch duct type intraductal papillary mucinous neoplasms of the pancreas
Scientific Title:Acronym
A prospective study of the natural history of pancreatic cyst including branch duct type IPMN
Region
| Japan |
Condition
Condition
Non-specific pancreatic cyst and branch duct type intraductal papillary mucinous neoplasm of the pancreas
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Branch duct type IPMN (BD-IPMN), which is representative cystic lesion of the pancreas, is associated with the pancreatic carcinogenesis, such as a malignant transformation of IPMN itself and a concomitant onset of pancreatic ductal adenocarcinoma. Though the small cysts of the pancreas sometimes cannot be classified with the specific cystic disease of the pancreas by imaging studies, some clinical and pathological reports indicate that most of those "non-specific" cysts of the pancreas are biologically similar with IPMN. Based on this insight, the recommendation of the clinical examinations for small cystic lesion including small BD-IPMN in every 2-3 years by the international guideline may be inadequate.
In response to the above, since September 2012 in our medical center, the imaging examinations in every 6 months have been performed for all the follow-up patients with BD-IPMN or non-specific pancreatic cyst. To estimate the risk of pancreatic carcinogenesis in those subjects and the contribution to the prognosis by the close follow-up, we designed a long-term and prospective cohort study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of pancreatic carcinogenesis in patients with non-specific pancreatic cyst or branch duct type intraductal papillary mucinous neoplasm of the pancreas
Key secondary outcomes
1) Prognosis of the subjects
2) The rate of progression of the pancreatic lesion
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with BD-IPMN or non-specific pancreatic cyst.
Key exclusion criteria
1) A concurrence of pancreatic malignancies at the time of diagnosis of IPMN.
2) The contraindication or rejection for the imaging examinations by EUS or MRCP.
3) The patients from whom the informed consent cannot be obtained.
4) The patients who are judged inappropriate for the participation for this study by the attending doctor.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Koshita |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, MIyagino-ku, Sendai, Japan
TEL
+81-22-252-1111
skoshita@openhp.or.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Koshita |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, MIyagino-ku, Sendai, Japan
TEL
+81-22-252-1111
Homepage URL
skoshita@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
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
Sendai City Medical Center
Address
5-22-1, Tsurugaya, MIyagino-ku, Sendai, Japan
Tel
+81-22-252-1111
skoshita@openhp.or.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
| 2015 | Year | 03 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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