UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021345
Receipt number R000024614
Scientific Title EUS imaging of background pancreas in patients with IPMN
Date of disclosure of the study information 2016/03/04
Last modified on 2018/03/08 15:30:46

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Basic information

Public title

EUS imaging of background pancreas in patients with IPMN

Acronym

EUS image of background pancreas in IPMN

Scientific Title

EUS imaging of background pancreas in patients with IPMN

Scientific Title:Acronym

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

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

7-5-2 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 Mamoru Takaenaka

Organization

Kobe University Graduate School of Medicine

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code


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 or person

Institute

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

Institute

Department

Personal name



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)



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

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


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

2010 Year 04 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024614


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name