UMIN-CTR Clinical Trial

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

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

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

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

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

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

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

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

Institute

Japan Pancreas Society

Institute

Department

Personal name

Organization

Japan Pancreas Society

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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

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

Date of disclosure of the study information

2012

Year

03

Month

01

Day

URL releasing protocol

http://www.med.kyushu-u.ac.jp/surgery1/research/research-application/13.pdf

Publication of results

Unpublished

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

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 related information

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

Registered date

2012

Year

02

Month

21

Day

Last modified on

2019

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008448