UMIN-CTR Clinical Trial

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
Institute	Hokkaido University Hospital, Gastroenterological surgery II
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046086