UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046197 |
|---|---|
| Receipt number | 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 | 2024/07/07 13:30:48 |
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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
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
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
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
Kita 14 Nishi 5, Kitaku, Sapporo city
Tel
011-706-1161
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
| 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
365
Results
The incidence of liver failure after hepatic lobectomy for hilar cholangiocarcinoma was 27.5%. Cases other than hepatic left caudate lobe resection were independent risk factors. Analysis of only the group of patients who underwent portal vein embolisation revealed that ICGKF <0.05, operative time >660 min and blood loss >1900 ml before portal vein embolisation were independent risk factors, and the operative mortality rate was 25% in cases requiring these three factors.
Results date posted
| 2024 | Year | 07 | Month | 07 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Paper is not accepted
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
Completed
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
| 2024 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052724
