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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046197
Receipt No. R000052724
Scientific Title Evaluation of risk factors for post hepatectomy liver failure and efficiency of potal vein embolization for perihilar cholangiocarcinoma surgery
Date of disclosure of the study information 2021/11/26
Last modified on 2021/11/26

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Basic information
Public title Evaluation of risk factors for post hepatectomy liver failure and efficiency of potal vein embolization for perihilar cholangiocarcinoma surgery
Acronym Evaluation for PHLF and efficiency for PTPE
Scientific Title Evaluation of risk factors for post hepatectomy liver failure and efficiency of potal vein embolization for perihilar cholangiocarcinoma surgery
Scientific Title:Acronym Evaluation for PHLF and efficiency for PTPE
Region
Japan

Condition
Condition Perihilar Cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate risk factors for post hepatectomy liver failure and find to prevent it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Risk factor for liver failure
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 Perihilar cholangiocarcinoma patients who underwent hepatectomy in Hokkaido University Gastroenterological surgery II
Key exclusion criteria 1. Early period death
2. Lacking clinical data
3. Other
Target sample size 310

Research contact person
Name of lead principal investigator
1st name Takehiro
Middle name
Last name Noji
Organization Hokkaido University Hospital
Division name Faculty of Medicine Gastroenterological surgery II
Zip code 060-8638
Address Kita15 Nishi7 Kitaku Sapporo city 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 Faculty of Medicine
Division name 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
Institute Hokkaido University
Institute
Department

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 Kita 14 Nishi 5, Kitaku, Sapporo city
Tel 011-706-1161
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
2021 Year 11 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 310
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2021 Year 08 Month 20 Day
Date of IRB
2021 Year 10 Month 15 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1) Type and design of the study
Observational study using existing information
(2) Research questions
The following information will be obtained and used for the study subjects until 31 March 2022.
(1) Background information: age, sex, medical history, diagnosis, treatment history, performance status
2) Hematological examination results: hemoglobin, white blood cell count, white blood cell fraction and platelet count
3) Blood chemistry test results: total protein, albumin, Na, K, serum tumor marker (CEA/CA19-9)
4) CT, MRI, ultrasound and cholangiogram results
5) Results of histopathological examination (histological type, degree of progression, lymph node metastasis)
(6) Operative procedure, operative time, amount of blood loss
(7) Postoperative course (presence of complications)
(viii) Treatment administered during postoperative hospitalization and duration.
(ix) Date of discharge, cause of death.

Management information
Registered date
2021 Year 11 Month 26 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052724

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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