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

Email

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


Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name