UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of tumor localization on the outcomes of surgery for an intrahepatic cholangiocarcinoma
Title of the study (Brief title)	Impact of tumor localization on the outcomes of surgery for an intrahepatic cholangiocarcinoma
Region	Japan

Condition
Condition	Intrahepatic cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the clinicopathological features and surgical outcomes of hilar type intrahepatic cholangiocarcinoma and peripheral type intrahepatic cholangiocarcinoma.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-year survival rate
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	10 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Intrahepatic cholangiocarcinoma patients who underwent several types of hepatectomy at the Department of Gastroenterological Surgery I at Hokkaido University Hospital between 1987 to 2017.
Key exclusion criteria	Liver disease other than intrahepatic cholangiocarcinoma
Target sample size	110

Research contact person
Name of lead principal investigator	Tatsuya Orimo
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery I
Address	North 15-West 7, Kita-Ku, Sapporo, Hokkaido 060-8638, Japan
TEL	011-706-5927
Email	tatsuori@med.hokudai.ac.jp

Public contact
Name of contact person	Tatsuya Orimo
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery I
Address	North 15-West 7, Kita-Ku, Sapporo, Hokkaido 060-8638, Japan
TEL	011-706-5927
Homepage URL
Email	tatsuori@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hokkaido University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	1987 Year 01 Month 01 Day
Anticipated trial start date	1987 Year 01 Month 01 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	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29721628
Results	HICC shows more frequent bile duct invasion and lymph node metastasis, requires more extensive surgery, and has a higher rate of non-curative resection than PICC. However, if curative resection is achieved, the survival outcomes are expected to be equivalent between HICC and PICC.
Other related information	HICC shows more frequent bile duct invasion and lymph node metastasis, requires more extensive surgery, and has a higher rate of non-curative resection than PICC. However, if curative resection is achieved, the survival outcomes are expected to be equivalent between HICC and PICC.

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2018 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035454