UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intraductal papillary neoplasm of the bile duct found incidentally during examination of colonic disease: A case report
Title of the study (Brief title)	Intraductal papillary neoplasm of the bile duct found incidentally during examination of colonic disease: A case report
Region	Japan

Condition
Condition	Intraductal papillary neoplasm of the bile duct
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	one patient
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	We are report a relatively rare case of IPNB. Although preoperative diagnosis of IPNB remains challenging, curative resection is the major treatment and an important factor in determining long-term survival.
Key secondary outcomes

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	54 years-old <=
Age-upper limit	54 years-old >=
Gender	Male
Key inclusion criteria	none
Key exclusion criteria	none
Target sample size	1

Research contact person
Name of lead principal investigator	Katsuhiro Tomofuji
Organization	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name	Department of Gastroenterological Surgery
Address	3-8-31 Ariake, Koto-ku, Tokyo
TEL	+81335200111
Email	xk62h.ykatsuz57@gmail.com

Public contact
Name of contact person	Katsuhiro Tomofuji
Organization	Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name	Department of Gastroenterological Surgery
Address	3-8-31 Ariake, Koto-ku, Tokyo
TEL	+81335200111
Homepage URL
Email	xk62h.ykatsuz57@gmail.com

Sponsor
Institute	None declared
Institute
Department

Funding Source
Organization	None declared
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Case report

Management information
Registered date	2017 Year 05 Month 31 Day
Last modified on	2017 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031603