UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040384
Receipt number R000046086
Scientific Title Role of GSA Scintigraphy to predict liver failure after perihilar cholangiocarcinoma surgery
Date of disclosure of the study information 2020/05/13
Last modified on 2021/11/19 16:53:14

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Basic information

Public title

Role of GSA Scintigraphy to predict liver failure after perihilar cholangiocarcinoma surgery

Acronym

GSA Scintigraphy and PHLF

Scientific Title

Role of GSA Scintigraphy to predict liver failure after perihilar cholangiocarcinoma surgery

Scientific Title:Acronym

GSA Scintigraphy and PHLF

Region

Japan


Condition

Condition

Perihilar cholangiocarcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficiency

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Liver failure-related death

Key secondary outcomes

Incidence of liver failure


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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with perihilar cholangiocarcinoma surgery in Hokkaido University (Surg II or Gastroenterological surgery II),

Key exclusion criteria

Data missing

Target sample size

183


Research contact person

Name of lead principal investigator

1st name TAKEHIRO
Middle name
Last name NOJI

Organization

Hokkaido University Hospital

Division name

Gastroenterological surgery II

Zip code

0608638

Address

Kita15 Nishi7, Kitaku, Sapporo city, Japan

TEL

011-706-7714

Email

drnoji@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Takehiro
Middle name
Last name Noji

Organization

Hokkaido University Hospital

Division name

Gastroenterological surgery II

Zip code

0608638

Address

Kita15 Nishi7, Kitaku, Sapporo city, Japan

TEL

011-706-7714

Homepage URL


Email

drnoji@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital, Gastroenterological surgery II

Institute

Department

Personal name



Funding Source

Organization

Selffunding

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

Hokkaido University Hospital Clinical Research and Medical Innovation Center

Address

Kita14 Nishi5, Kita-ku, Kita14 Nishi

Tel

011-716-1161

Email

crjimu@huhp.hokudai.ac.jp


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

2020 Year 05 Month 13 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007%2Fs11605-021-05066-2

Publication of results

Unpublished


Result

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs11605-021-05066-2

Number of participants that the trial has enrolled

183

Results

Efficiency of GSA(LHL15) was shown by this tstudy

Results date posted

2021 Year 11 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

183patients were enrolled in this study

Participant flow

None

Adverse events

None

Outcome measures

Show the detail in the paper

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 03 Month 01 Day

Date of IRB

2020 Year 05 Month 01 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2020 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

There were 181 consecutive PHCC patients subjected to major hepatectomy with extrahepatic bile duct resection with or without pancreaticoduodenectomy at Hokkaido University, Dept. of Gastroenterological Surgery II between January 2005 and December 2015.


Management information

Registered date

2020 Year 05 Month 13 Day

Last modified on

2021 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name