UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046581 |
|---|---|
| Receipt number | R000053141 |
| Scientific Title | Short- and long-term outcome study of surgery for hilar cholangiocarcinoma in high-risk patients (multicentre study) |
| Date of disclosure of the study information | 2022/02/27 |
| Last modified on | 2022/01/07 17:30:06 |
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Basic information
Public title
Short- and long-term outcome study of surgery for hilar cholangiocarcinoma in high-risk patients (multicentre study)
Acronym
High-risk hilar cholangiocarcinoma surgical survey
Scientific Title
Short- and long-term outcome study of surgery for hilar cholangiocarcinoma in high-risk patients (multicentre study)
Scientific Title:Acronym
High-risk hilar cholangiocarcinoma surgical survey
Region
| Japan |
Condition
Condition
Perihilr cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the postoperative complications and prognostic information in cases of radical surgery with hepatic resection for hilar region cholangiocarcinoma and high-risk cases, and to clarify the surgical outcomes for high-risk hilar cholangiocarcinoma cases in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year survival rate
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
Vascular disease: on anticoagulant medication
Diabetes mellitus: taking more than one diabetes medication or using insulin
(3) Do not refuse to participate in this study
Key exclusion criteria
(1) Patients with insufficient clinical data
(2) Other patients who are judged by the principal investigator to be unsuitable as research subjects.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido university
Division name
Gastroenterological surgery II
Zip code
060-8638
Address
kita15 Nishi7, Kita-ku, 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
Division name
Faculty of Medicine Gastroenterological surgery II
Zip code
060-8638
Address
Kita-ku
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
Hokkaido University IRB
Address
Kita14 Nishi5, Kita-ku, Sapporo city, Japan
Tel
0117161161
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
| 2022 | Year | 02 | Month | 27 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
Multicentre observational study using existing information
(2) Study items
Medical information on the study subjects will be collected until December 31, 2026, and the following items will be investigated.
(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) Type and duration of postoperative treatment.
(viii) Type and duration of postoperative treatment (ix) Time to recurrence, site of recurrence, prognosis of life, date of last hospital visit, cause of death
Management information
Registered date
| 2022 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053141
