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
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
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
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
