UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019927
Receipt number R000023007
Scientific Title Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma
Date of disclosure of the study information 2015/11/25
Last modified on 2019/02/14 12:22:09

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Basic information

Public title

Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma

Acronym

Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma

Scientific Title

Evaluation of surgical results for concomitant hepatic artery resection in perihilar cholangiocarcinoma

Scientific Title:Acronym

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

1st name
Middle name
Last name Takehiro Noji

Organization

Hokkaido University Graduate School of Medicine

Division name

Gastroenterological Surgery II

Zip code


Address

Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido

TEL

011-716-2111

Email

drnoji@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takehiro Noji

Organization

Hokkaido University Graduate School of Medicine

Division name

Gastroenterological Surgery II

Zip code


Address

Kita15 Nishi7, Kita-ku, Sapporo city, Hokkaido

TEL

011-716-2111

Homepage URL


Email

drnoji@med.hokudai.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 11 Month 25 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023007


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name