UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	EUS imaging of background pancreas in patients with IPMN
Title of the study (Brief title)	EUS image of background pancreas in IPMN
Region	Japan

Condition
Condition	intraductal papillary mucnous neoplasm
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The recent guideline for intraductal papillary mucinous neoplasms (IPMNs) focuses on morphological features of the lesion as signs of malignant transformation, but ignores the background pancreatic parenchyma, including features of chronic pancreatitis, a risk factor for pancreatic malignancies. Endoscopic ultrasonography frequently reveals evidence of chronic pancreatitis (EUS-CP findings) in the background pancreatic parenchyma of patients with IPMNs. Therefore, we investigated whether background EUS-CP findings were associated with malignant IPMN.
Basic objectives2	Others
Basic objectives -Others	Association of EUS-CP findings(chronic pancreatitis like change detected by EUS) with invasive IPMC
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Association of EUS-CP findings(chronic pancreatitis like change detected by EUS) with invasive IPMC
Key secondary outcomes	2. Association of EUS-CP findings with pathological changes of the pancreatic parenchyma 3. Association of pathological changes in the pancreatic parenchyma 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	90 years-old >
Gender	Male and Female
Key inclusion criteria	69 consecutive patients with IPMNs in whom EUS was performed before surgical resection at Kobe University Hospital from April 2010 to October 2014
Key exclusion criteria	Patients with concomitant pancreatic carcinoma (defined by the presence of two discrete tumors)
Target sample size	69

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	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-6305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	Mamoru Takaenaka
Organization	Kobe University Graduate School of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL	078-382-6305
Homepage URL	http://www.med.kobe-u.ac.jp/gi/ushiroall.html
Email	mamox@med.kobe-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	JSPS KAKENHI, Research Committee of Intractable Pancreatic Diseases from the Ministry of Health, Labour, and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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	神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 04 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 04 Month 01 Day
Date analysis concluded	2016 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Clinical data were collected for 69 consecutive patients with IPMNs in whom EUS was performed before surgical resection at Kobe University Hospital from April 2010 to October 2014. Patients with concomitant pancreatic carcinoma (defined by the presence of two discrete tumors) were excluded. We investigated various clinical and tumor characteristics, including the age, sex, abdominal symptoms (presence vs. absence), serum CEA (< 5 ng/ml vs. more than 5 ng/ml), serum CA19-9 (< 37 U/ml vs. more than 37 U/ml), diabetes mellitus (presence vs. absence), habitual drinking (none/sometimes/daily), alcohol consumption (< 50 g/day vs. more than 50 g/day), macroscopic type of IPMN (main duct, mixed, or branch duct type), cyst location (head vs. body/tail), main pancreatic duct diameter (<5 mm, 5-10 mm, >10 mm), mural nodule in the cyst (presence vs. absence), cyst diameter (<30 mm, 30-40 mm, > 40 mm), and tumor mucin phenotype (intestinal, gastric, pancreatobiliary, or oncocytic).

Management information
Registered date	2016 Year 03 Month 04 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=R000024614