UMIN-CTR Clinical Trial

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

intraductal papillary mucnous neoplasm

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

神戸大学医学部附属病院

Date of disclosure of the study information

2016

Year

03

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

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