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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007053
Receipt No. 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

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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
Institute Department of Gastroenterology, Nagoya University Hospital
Institute
Department

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
URL(English) https://upload.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


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