UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007053
Receipt number R000006568
Scientific Title A multicenter study of natural history of pancreatic cystic lesions.
Date of disclosure of the study information 2012/01/15
Last modified on 2016/01/12 18:37:54

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Basic information

Public title

A multicenter study of natural history of pancreatic cystic lesions.

Acronym

N-SPINAL
(Nagoya-Study of Pancreatic cyst and IPMNs Natural history analysis)

Scientific Title

A multicenter study of natural history of pancreatic cystic lesions.

Scientific Title:Acronym

N-SPINAL
(Nagoya-Study of Pancreatic cyst and IPMNs Natural history analysis)

Region

Japan


Condition

Condition

Pancreatic cystic lesions

Classification by specialty

Medicine in general Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the natural history of pancreatic cystic lesions.

Basic objectives2

Others

Basic objectives -Others

The occurrence ratio of morphological change and malignant alteration of pancreatic cystic lesions.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Natural history of the pancreatic cystic lesions.

Key secondary outcomes

Incidence of change of image findings.

Malignant alteration ratio of follow up patients.

Resection ratio of follow up patients.

Complication of other organ malignancies.


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patients diagnosed as pancreatic cystic lesions at Nagoya university hospital and affiliated hospitals.
2. Pancreatic cystic lesions diagnosed by EUS.
3. 20-80 years of age
4. asymptomatic cases
5. deviated from our surgical indications
6. patients with adequate main organs function
7. patients who provided written informed consent

Key exclusion criteria

1. Patients with symptoms associated with pancreatic lesion.
2. Pregnant and lactating woman
3. Patients with severe drug-induced allergy
4. Difficulty with receiving endoscopic examination.
5. Patients with a history of pancreatic resection.
6. Patients with severe impairment
7. Patients judged as inappropriate by attendant doctor.
8. Patients diagnosed as pancreatic pseudocyst
9. Candidate for surgical treatment.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Hirooka

Organization

Nagoya University Hospital

Division name

Department of Endoscopy

Zip code


Address

65 Tsuruma-cho, Showa-ku, Nagoya

TEL

052-744-2602

Email

hirooka@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eizaburo Ohno

Organization

Nagoya University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

65 Tsuruma-cho, Showa-ku, Nagoya

TEL

052-744-2602

Homepage URL

http://center6.umin.ac.jp/islet/nspinal/

Email

eono@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

Aichi Cancer Center Central Hospital, Fujita Health University Hospital, Ogaki City Hospital, etc.

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

名古屋大学医学部附属病院(愛知県) Nagoya University Hospital
愛知県がんセンター中央病院(愛知県)、Aichi Cancer Center Central Hospital
藤田保健衛生大学(愛知県)、 Fujita Health University Hospital
小牧市民病院(愛知県)、 Komaki City Hospital
大垣市民病院(岐阜県)、       Ogaki City Hospital
東海中央病院(岐阜県)、       Toukai Central Hospital
岡崎市民病院(愛知県)、       Okazaki City Hospital
名古屋第一赤十字病院(愛知県)、 Japanese Red Cross Nagoya Daiichi Hospital
大同病院(愛知県)、 Daido Hospital
豊橋市民病院(愛知県)、 Toyohashi City Hospital
一宮市立市民病院(愛知県)、 Ichinomiya City Hospital
江南厚生病院(愛知県)、 Kounankosei Hospital
安城更生病院(愛知県)、 Anjokosei Hospital
豊田厚生病院(愛知県)、 Toyotakosei Hospital
総合上飯田第一病院(愛知県)、 Kamiiida Daiichi General Hospital
八千代病院(愛知県)、 Yachiyo Hospital
公立陶生病院(愛知県) Tosei General Hospital
東海病院(愛知県)          Toukai Hospital
山下病院(愛知県)          Yamashita Hospital
名鉄病院(愛知県)          Meitetsu Hospital
半田市立半田病院(愛知県)      Handa Municipal Hospital


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 15 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

Open public recruiting

Date of protocol fixation

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Multicenter prospective cohort study
Parameters
1) Imaging findings
Clinical diagnosis
Diagnostic modality
Maximum size and features of pancreatic cyst
Maximum size of main pancreatic duct
Maximum size of mural nodules

2) Clinical information and laboratory data
Past history
Family history
Complication of diabetes mellitus
Symptoms
Laboratory data
Pancreatic enzyme
Tumor markers


Management information

Registered date

2012 Year 01 Month 11 Day

Last modified on

2016 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006568


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name