UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma
Title of the study (Brief title)	Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma
Region	Japan

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

Objectives
Narrative objectives1	To evaluate surgical results of concomitant hepatic artery resection in perihilar cholangiocarcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Short and long term outcome
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patietns with perihilar cholangiocarcinoma in Hokkaido University Hospital (department of Surgery II or Gastroeterological surgery II), during period from January 2000 to September 2015.
Key exclusion criteria	Palliative intention, surgery after chemotherapy.
Target sample size	220

Research contact person
Name of lead principal investigator	Takehiro Noji
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological Surgery II
Address	Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido
TEL	011-716-2111
Email	drnoji@med.hokudai.ac.jp

Public contact
Name of contact person	Takehiro Noji
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological Surgery II
Address	Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido
TEL	011-716-2111
Homepage URL
Email	drnoji@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Graduate school of Medicine, Department of Gastroenterological surgery II
Institute
Department

Funding Source
Organization	Hokkaido University Graduate school of Medicine, Department of Gastroenterological surgery II
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 11 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 25 Day
Anticipated trial start date	2015 Year 11 Month 25 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
Results
Other related information	Among 220 patients with perihilar cholangiocarcinoma, 11 patients were excluded. We are evaluating prognosis and postoperative complication.

Management information
Registered date	2015 Year 11 Month 25 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023007