UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020140 |
|---|---|
| Receipt number | R000023241 |
| Scientific Title | The association of exocrine function with malignant transformation in surgically resected intraductal papillary mucinous neoplasms |
| Date of disclosure of the study information | 2015/12/14 |
| Last modified on | 2018/03/08 15:30:11 |
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Basic information
Public title
The association of exocrine function with malignant transformation in surgically resected intraductal papillary mucinous neoplasms
Acronym
Low pancreatic enzyme and atrophy in IPMN
Scientific Title
The association of exocrine function with malignant transformation in surgically resected intraductal papillary mucinous neoplasms
Scientific Title:Acronym
Low pancreatic enzyme and atrophy in IPMN
Region
| Japan |
Condition
Condition
intraductal papillary mucinous neoplasm
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
whether low level of pancreatic enzyme and pancreatic atrophy and inflammation are associated with high incidence of invasive IPMN
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the association of serum pancreatic enzymes and malignant IPMN
Key secondary outcomes
1. the association of serum pancreatic enzymes with pancreatic atrophy and pancreatic stone on CT
2. the association of serum pancreatic enzymes with pathological examination (atrophy and inflammation)
3. the association of pathological examination (atrophy and inflammation) with malignant IPMN
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
Patients with IPMN diagnosed by MRCP or CT preoperatively
Key exclusion criteria
1. Patients with pancreatic carcinoma concomitant with IPMN
2. Patients with the stenosis of main pancreatic duct due to mass formation of invasive IPMN
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Masuda |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Yagi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6305
Homepage URL
goatomc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 14 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study included 146 consecutive patients with surgically resected IPMNs between April 2001 to October 2014. Multivariable logistic regression analysis was conducted to assess the association between serum pancreatic enzymes (serum pancreatic amylase and serum lipase) and the incidence of invasive IPMN, adjusted for clinical characteristics including alcohol consumption. The association of pancreatic atrophy and infiltration of inflammatory cells with invasive IPMN were evaluated at the part adjacent to and away from the tumor.
Management information
Registered date
| 2015 | Year | 12 | Month | 09 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023241
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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