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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020140
Receipt No. 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

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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
Email 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
Email goatomc@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023241

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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