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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007349
Receipt No. R000008448
Scientific Title A surveillance study of branch duct intraductal papillary mucinous neoplasm of the pancreas; a multicenter prospective study.
Date of disclosure of the study information 2012/03/01
Last modified on 2019/03/01

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Basic information
Public title A surveillance study of branch duct intraductal papillary mucinous neoplasm of the pancreas; a multicenter prospective study.
Acronym A surveillance study of branch duct IPMN
Scientific Title A surveillance study of branch duct intraductal papillary mucinous neoplasm of the pancreas; a multicenter prospective study.
Scientific Title:Acronym A surveillance study of branch duct IPMN
Region
Japan

Condition
Condition Branch duct intraductal mucinous papillary neoplasm of pancreas (BD-IPMN)
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the natural history of branch duct intraductal papillary mucinous neoplasms of the pancreas (BD-IPMN).
Basic objectives2 Others
Basic objectives -Others To elucidate the incidences of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPMN.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the incidences of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPMN

the progression of BD-IPMN
Key secondary outcomes prognosis (overall survival time)

cyst size, MPD diameter, height of mural nodule

age, sex, family history, and operation

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed as having BD-IPMN showing dilated branch duct (>10mm), which has a communication with MPD detected by MRCP or ERCP.
2. Patients having fish-eye appearance of duodenal papilla or mucin in pancreatic duct found during ERCP.
Key exclusion criteria 1. absence of communication between cysts and MPD
2. MPD diameter more than 10 mm
3. concomitant with pancreatic ductal adenocarcinoma at diagnosis
4. contraindication for MRCP
5. contraindication for CT
6. contraindication for EUS
7. not given informed consent
8. considered ineligble by attendant doctors
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Tanaka
Organization Kyushu University
Division name Department of Surgery and Oncology
Zip code
Address 3-1-1 Maidashi, Fukuoka
TEL 092-642-5440
Email masaotan@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Maguchi
Organization Teine-Keijinkai Hospital
Division name Center for Gastroenterology
Zip code
Address 1-12-1-40 Maeda, Sapporo
TEL 011-681-8111
Homepage URL
Email maguchi@tb3.so-net.ne.jp

Sponsor
Institute Japan Pancreas Society
Institute
Department

Funding Source
Organization Japan Pancreas Society
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 九州大学病院 (福岡県) Kyushu University Hospital
手稲渓仁会病院(北海道)Teine-Keijinkai Hospital
琴似ロイヤル病院(北海道)Kotoni Royal Hospital
札幌厚生病院(北海道)Sapporo-Kosei General Hospital
福島県立医科大学会津医療センター(福島県)Fukushima Medical University, Aizu Medical Center
山形大学(山形県)Yamagata University
仙台市医療センター仙台オープン病院(宮城県) Sendai Open Hospital
東京女子医科大学(東京都)Tokyo Women's Medical University
東京大学(東京都)Tokyo University
順天堂大学(東京)Juntendo University
三井記念病院(東京)Mitsui Memorial Hospital
杏林大学(東京)Kyorin University
横浜市立大学(神奈川県)Yokohama City University
北里大学東病院(神奈川県)Kitasato University East Hospital
千葉県がんセンター(千葉県)Chiba Cancer Center
佐久総合病院(長野県)Saku Central Hospital
飯田市立病院(長野県)Iida Municipal Hospital
大阪府立成人病センター(大阪府)Osaka Medical Center for Cancer and Cardiovascular Diseases
関西医科大学(大阪)Kansai Medical University
大阪医科大学(大阪)Osaka Medical University
京都大学(京都)Kyoto University
愛知県がんセンター(愛知県)Aichi Cancer Center Hospital
和歌山県立医科大学(和歌山)Wakayama Medical University
尾道総合病院(広島県)Onomichi General Hospital
産業医科大学(福岡県)University of Occupational and Environmental Health
旭川厚生病院 (北海道) Asahikawa-Kosei General Hospital
北海道大学 (北海道) Hokkaido University
札幌医科大学 (北海道) Sapporo Medical University
東北大学 (宮城県) Tohoku University
宮城県立がんセンター (宮城県) Miyagi Cancer Center
千葉大学 (千葉県) Chiba University
亀田総合病院 (千葉県) Kameda General Hospital
船橋市立医療センター (千葉県) Funabashi Municipal Medical Center
せんぽ東京高輪病院 (東京都) Senpo Tokyo Takanawa Hospital
日本赤十字社医療センター (東京都) Japanese Red Cross Medical Center
東京警察病院 (東京都) Tokyo Metropolitan Police Hospital
関東中央病院 (東京都) Kanto Central Hospital
東京医科大学 (東京都) Tokyo Medical University
岐阜大学医学部附属病院 (岐阜県) Gifu University Hospital
岐阜市民病院 (岐阜県) Gifu Municipal Hospital
岐阜県総合医療センター (岐阜県) Gifu Prefectural Medical Center
三重大学 (三重県) Mie University
鈴鹿中央総合病院 (三重県) Suzuka Central General Hospital
松阪中央総合病院 (三重県) Matsuzaka Central General Hospital
京都府立医科大学 (京都府) Kyoto Prefectural University of Medicine
大阪大学大学院医学系研究科 (大阪府) Osaka University
大阪府立急性期・総合医療センター (大阪府) Osaka General Medical Center
近畿大学医学部 (大阪府) Kinki University Faculty of Medicine
淀川キリスト教病院 (大阪府) Yodogawa Christian Hospital
鳥取大学(鳥取県)Tottoti University
島根大学(島根県)Shimane University
岡山大学 (岡山県) Okayama University
川崎医科大学 (岡山県) Kawasaki Medical School
広島大学 (広島県) Hiroshima University
JA広島総合病院 (広島県) JA Hiroshima General Hospital
広島赤十字・原爆病院 (広島県) Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
愛媛大学(愛媛県)Ehime University
小倉医療センター (福岡県) Kokura Medical Center
北九州市立医療センター (福岡県) Kitakyushu Municipal Medical Center
九州厚生年金病院 (福岡県) Kyushu Kosei Nenkin Hospital
久留米大学 (福岡県) Kurume University
済生会福岡総合病院 (福岡県) Saiseikai Fukuoka General Hospital
九州医療センター (福岡県) Kyushu Medical Center
福岡大学筑紫病院 (福岡県) Fukuoka University Chikushi Hospital
飯塚病院(福岡県)Izuka Hospital
熊本赤十字病院(熊本県)Japanease Red Cross Kumamoto Hospital
熊本大学(熊本県)Kumamoto University
宮崎大学 (宮崎県) Miyazaki University
鹿児島大学(鹿児島)Kagoshima University
沖縄県立中部病院(沖縄県)Okinawa Prefectural Chubu Hospital
浦添総合病院(沖縄県)Urasoe General Hospital
愛媛大学(愛媛県)Ehime University
山梨大学(山梨県)Yamanashi University

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 01 Day

Related information
URL releasing protocol http://www.med.kyushu-u.ac.jp/surgery1/research/research-application/13.pdf
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Ongoing
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 No longer recruiting
Date of protocol fixation
2012 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A multicenter prospective cohort study.
Patients are registered by the patient registration center system at Kyushu University Medical Information Center.

Management information
Registered date
2012 Year 02 Month 21 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008448

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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