UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045055 |
|---|---|
| Receipt number | R000051472 |
| Scientific Title | Validation study for prognostic impact for the systematic inflammatory response in perihilar cholangiocarcinoma |
| Date of disclosure of the study information | 2021/08/03 |
| Last modified on | 2023/11/15 23:39:28 |
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Basic information
Public title
Validation study for prognostic impact for the systematic inflammatory response in perihilar cholangiocarcinoma
Acronym
Validation study for SIR in perihilar cholangiocarcinoma
Scientific Title
Validation study for prognostic impact for the systematic inflammatory response in perihilar cholangiocarcinoma
Scientific Title:Acronym
Validation study for SIR 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
Validation for a prognostic score for perihilar cholangiocarcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year survival based on prognostic scores.
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
(1) Cases in which radical surgery with hepatectomy was performed
(2) Those who have not offered to refuse participation in this research from the research subjects or those who are considered to be able to represent the intentions and interests of the research subjects.
Key exclusion criteria
1.Deaths within 90 days after surgery
2.Cases of lack of clinical data
3.Other patients who the principal investigator deems inappropriate as research subjects.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University
Division name
Faculty of Medicine Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi7 Kita-ku, Sapporo city, Hokkaido, japan
TEL
0117067714
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University
Division name
Faculty of Medicine Gastroenterological surgery II
Zip code
060-8638
Address
Kita15 Nishi7 Kita-ku, Sapporo city, Hokkaido, japan
TEL
0117067714
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Faculty of Medicine Gastroenterological surgery II
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
IRB Hokkaido University Hospital
Address
Kita14 Nishi5, Kita-ku, Sapporo city, Hokkaido Japan
Tel
011-706-7636
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
| 2021 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Langenbecks Arch Surg . 2023 Nov 8;408(1):430. doi: 10.1007/s00423-023-03145-3.
Publication of results
Published
Result
URL related to results and publications
Langenbecks Arch Surg . 2023 Nov 8;408(1):430. doi: 10.1007/s00423-023-03145-3.
Number of participants that the trial has enrolled
125
Results
Langenbecks Arch Surg . 2023 Nov 8;408(1):430. doi: 10.1007/s00423-023-03145-3.
Results date posted
| 2023 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Langenbecks Arch Surg . 2023 Nov 8;408(1):430. doi: 10.1007/s00423-023-03145-3.
Participant flow
Langenbecks Arch Surg . 2023 Nov 8;408(1):430. doi: 10.1007/s00423-023-03145-3.
Adverse events
None
Outcome measures
Langenbecks Arch Surg . 2023 Nov 8;408(1):430. doi: 10.1007/s00423-023-03145-3.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
The following items will be investigated for the research subjects. Obtain and use information up to December 31, 2021.
1)Background information: age, gender, medical history, diagnosis name, treatment history, Performance Status
2) Hematological test results: hemoglobin, white blood cell count, white blood cell fraction / platelet count
3) Blood biochemical test results: total protein, albumin, Na, K, serum tumor marker (CEA / CA19-9)
4) CT / MRI / ultrasound / cholangiography image test results
5) Histopathological examination results (histological type, progression, lymph node metastasis)
6) Operation method, operation time, bleeding amount
7) Postoperative course (presence or absence of complications)
8) Postoperative treatment type and period.
9)Period until recurrence, recurrence site, the prognosis of life, date of last visit, cause of death
Management information
Registered date
| 2021 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051472
