UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009286 |
|---|---|
| Receipt number | R000010896 |
| Scientific Title | A prospective study of branch duct intraductal papillary mucinous neoplasm of the pancrease; a single-center prospective study. |
| Date of disclosure of the study information | 2012/11/09 |
| Last modified on | 2018/11/14 10:39:48 |
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Basic information
Public title
A prospective study of branch duct intraductal papillary mucinous neoplasm of the pancrease; a single-center prospective study.
Acronym
A prospective surveillance study of brunch duct IPMN.
Scientific Title
A prospective study of branch duct intraductal papillary mucinous neoplasm of the pancrease; a single-center prospective study.
Scientific Title:Acronym
A prospective surveillance study of brunch duct IPMN.
Region
| Japan |
Condition
Condition
Branch duct intraductal mucinous papillary neoplasm of the pancrease(BD-IPMN).
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the natural history of BD-IPMN.
Basic objectives2
Others
Basic objectives -Others
To evaluate the incidence of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPMN.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The progression of BD-IPMN
Key secondary outcomes
The incidence of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPM.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed as BD-IPMN, which has a communication with MPD detected by MRCP or EUS or ERCP.
2) Patients having fish-eye appearance of duodenal papilla or apparent mucin in pancreatic duct found in ERCP.
3) Patients over 20 years
4) Patients accepted informed consent
Key exclusion criteria
1) MPD diameter more than 10mm
2) mural nodule more than 5mm
3) pancreatic stones and dilated or stenotic MPD induced by chronic pancreatitis
4) concomitant with pancreatic ductal adenocarcinoma at the diagnosis
5) considered ineligible by attendant doctors
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kida |
Organization
Kitasato University School of Medicine
Division name
Gastroenterology
Zip code
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0380 Japan
TEL
042-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Iwai |
Organization
Kitasato University School of Medicine
Division name
Gastroenterology
Zip code
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0380 Japan
TEL
042-778-8111
Homepage URL
t-iwai@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology Kitasato University School of Medicine
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
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
北里大学東病院 Kitasato University East Hospital
北里大学病院 Kitasato University Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 09 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
A single-center prospective cohort study
Management information
Registered date
| 2012 | Year | 11 | Month | 08 | Day |
Last modified on
| 2018 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010896
| 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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| Registered date | File name |
