UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The association of exocrine function with malignant transformation in surgically resected intraductal papillary mucinous neoplasms
Title of the study (Brief title)	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	Atsuhiro Masuda
Organization	Kobe University Graduate School of Medicine
Division name	Division of Gastroenterology, Department of Internal medicine
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	Yosuke Yagi
Organization	Kobe University Graduate School of Medicine
Division name	Division of Gastroenterology, Department of Internal medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 11 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023241