UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A surveillance study of branch duct intraductal papillary mucinous neoplasm of the pancreas; a multicenter prospective study.
Title of the study (Brief title)	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	Masao Tanaka
Organization	Kyushu University
Division name	Department of Surgery and Oncology
Address	3-1-1 Maidashi, Fukuoka
TEL	092-642-5440
Email	masaotan@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person	Hiroyuki Maguchi
Organization	Teine-Keijinkai Hospital
Division name	Center for Gastroenterology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 01 Month 13 Day
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

Related information
URL releasing protocol	http://www.med.kyushu-u.ac.jp/surgery1/research/research-application/13.pdf
Publication of results	Unpublished
URL releasing results
Results	Ongoing
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/icdr_e/ctr_view.cgi?recptno=R000008448