UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063556 |
|---|---|
| Receipt number | R000072732 |
| Scientific Title | Short- and long-term surgical results of extended resection for perihilar cholangiocarcinoma |
| Date of disclosure of the study information | 2026/11/07 |
| Last modified on | 2026/11/07 16:40:18 |
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Basic information
Public title
Short- and long-term surgical results of extended resection for perihilar cholangiocarcinoma
Acronym
Short- and long-term surgical results of extended resection for perihilar cholangiocarcinoma
Scientific Title
Short- and long-term surgical results of extended resection for perihilar cholangiocarcinoma
Scientific Title:Acronym
Short- and long-term surgical results of extended resection for 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
The aims of this study were to evaluate the short- and long-term outcomes of upfront VR and HPD compared with standard resection (SR),
Basic objectives2
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
Patients with perihilar cholangiocarcinoma who were either outpatients or inpatients at the Department of Gastrointestinal Surgery II, Hokkaido University Hospital, between January 1, 2004, and June 30, 2025, and who did not refuse to participate in this study
Key exclusion criteria
1. Probe laparotomy
2. Previous surgery (extrahepatic bile duct resection or pancreaticoduodenectomy)
3. Preoperative chemotherapy
4. Any other individuals whom the principal investigator deems unsuitable to participate in the study
Target sample size
348
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Noji |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060-0812
Address
Kita12 Nishi5, Kitaku, Sapporo city, Japan
TEL
0117063375
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 Health Sciences
Zip code
060-0812
Address
kita12 Nishi5, Kita-ku, Sapporo city, Japan
TEL
0117067714
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Faculty of Health Sciences
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14 Nishi5, Kitaku, Sapporo city, 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
| 2026 | Year | 11 | Month | 07 | 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
348
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
| 2026 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background: Vascular resection (VR) and hepatopancreatoduodenectomy (HPD) are increasingly equated with borderline resectable (BR) perihilar cholangiocarcinoma (PHCC), for which neoadjuvant therapy is considered, although its benefit is unproven. This study evaluated upfront VR and HPD and examined whether CA19-9 identifies patients at high risk of nodal metastasis or portal vein invasion.
Methods: Consecutive patients undergoing upfront resection for PHCC between 2004 and 2025 at a single institution were classified as standard resection (SR, n = 141), HPD (n = 59), or VR (n = 148). The association of preoperative CA19-9 with pathological lymph node metastasis (pN+) and portal vein invasion (pPV+) was analyzed using restricted cubic spline logistic regression.
Management information
Registered date
| 2026 | Year | 11 | Month | 07 | Day |
Last modified on
| 2026 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072732
