UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009286
Receipt No. R000010896
Scientific Title A prospective study of branch duct intraductal papillary mucinous neoplasm of the pancrease; a single-center prospective study.
Date of disclosure of the study information 2012/11/09
Last modified on 2018/11/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A prospective study of branch duct intraductal papillary mucinous neoplasm of the pancrease; a single-center prospective study.
Acronym A prospective surveillance study of brunch duct IPMN.
Scientific Title A prospective study of branch duct intraductal papillary mucinous neoplasm of the pancrease; a single-center prospective study.
Scientific Title:Acronym A prospective surveillance study of brunch duct IPMN.
Region
Japan

Condition
Condition Branch duct intraductal mucinous papillary neoplasm of the pancrease(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 evaluate the natural history of BD-IPMN.
Basic objectives2 Others
Basic objectives -Others To evaluate the incidence of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPMN.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The progression of BD-IPMN
Key secondary outcomes The incidence of carcinoma derived from BD-IPMN and ductal carcinoma concomitant with BD-IPM.

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed as BD-IPMN, which has a communication with MPD detected by MRCP or EUS or ERCP.
2) Patients having fish-eye appearance of duodenal papilla or apparent mucin in pancreatic duct found in ERCP.
3) Patients over 20 years
4) Patients accepted informed consent
Key exclusion criteria 1) MPD diameter more than 10mm
2) mural nodule more than 5mm
3) pancreatic stones and dilated or stenotic MPD induced by chronic pancreatitis
4) concomitant with pancreatic ductal adenocarcinoma at the diagnosis
5) considered ineligible by attendant doctors
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Kida
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0380 Japan
TEL 042-778-8111
Email m-kida@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Iwai
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0380 Japan
TEL 042-778-8111
Homepage URL
Email t-iwai@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology Kitasato University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 北里大学東病院 Kitasato University East Hospital
北里大学病院 Kitasato University Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 09 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 Completed
Date of protocol fixation
2012 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
2018 Year 11 Month 01 Day
Date trial data considered complete
2018 Year 11 Month 01 Day
Date analysis concluded
2018 Year 11 Month 01 Day

Other
Other related information A single-center prospective cohort study

Management information
Registered date
2012 Year 11 Month 08 Day
Last modified on
2018 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.