UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057783 |
|---|---|
| Receipt number | R000066040 |
| Scientific Title | Validation of the anatomical classification in peripheral and proximal type of intrahepatic cholangiocarcinoma |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/06 22:37:49 |
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Basic information
Public title
Validation of the anatomical classification in peripheral and proximal type of intrahepatic cholangiocarcinoma; Japan-Korea Collaborative Research
Acronym
Validation of the anatomical classification in peripheral and proximal type of intrahepatic cholangiocarcinoma
Scientific Title
Validation of the anatomical classification in peripheral and proximal type of intrahepatic cholangiocarcinoma
Scientific Title:Acronym
Validation of the anatomical classification in peripheral and proximal type of intrahepatic cholangiocarcinoma
Region
| Japan | Asia(except Japan) |
Condition
Condition
Intrahepatic cholangiocarcinoma
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to validate whether the anatomic classification in peripheral and proximal type of intrahepatic cholangiocarcinoma (iCCA) is a useful classification that can predict prognosis after resection of iCCA, lymph node metastasis of iCCA, and curative resection through an international multicenter study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rates, Disease-free survival
Key secondary outcomes
Lymph node metastasis, Resection margin
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, iCCA treated between Jan, 2011 and Dec, 2020 (for 10 years)
2, Surgical resection as a first line therapy
3, Patients histologically diagnosed as iCCA
4, iCCA gross type was MF (mass forming type) or MF+PI (bile duct invasion type)
5, Patients who were more than 20 years old at the time of surgery
6, Contrast-enhanced CT or MRI was performed within 1 month before hepatectomy
Key exclusion criteria
1, Patients with other synchronous or metachronous cancer
2, Patients who received preoperative local therapy (TACE,RF,radiotherapy,etc.) or preoperative chemotherapy
3, Intraductal papillary neoplasm of the bile duct (IPNB) cases are excluded
4, Combined hepatocellular-cholangiocarcinoma cases are excluded
5, Perihilar cholangiocarcinoma cases are excluded
6, Patients who died within 90-days after surgery because of operative complications
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Yagi |
Organization
Kanazawa University
Division name
Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
9208640
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
0762652362
yagi@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Nakanuma |
Organization
Kanazawa University
Division name
Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
9208641
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
0762652362
Homepage URL
s-nakanuma@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kanazawa University Hospital
Address
13-1 Takaramachi, Kanazawa
Tel
0762652110
rinri@adm.kanazawa-u.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
| 2025 | Year | 05 | Month | 30 | 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
1600
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
| 2023 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
BACKGROUND:
In the 2019 WHO classification,iCCA was pathologically subclassified into two types, depending on whether it derives from small or large bile ducts.The difference in bile duct location where iCCA occurs affects the biological characteristics of iCCA. In recent years, the usefulness of classification based on the anatomical location of iCCA has been focused on. The difference in bile duct location where iCCA occurs affects the biological characteristics of iCCA. In recent years, the usefulness of classification based on the anatomical location of iCCA has been focused on. The iCCA located in the peripheral region of the liver have reported less invasion, less lymph node (LN) metastasis, and better prognosis compared to that of iCCA located in the proximal or central region. However, these studies were conducted at a single institution, with a small number of cases, and lacking a fixed definition of `proximal` and `distal`; thus, reaching a consensus was difficult. In our current study, we will investigate the impact of the anatomical classification of iCCA based on the relationship between Glissonean pedicles (GP)from an oncological perspective.
METHODOLOGY:
A case report form (CRF) will be distributed to the Japanese and Korean authorities. Data on patient characteristics, preoperative CT findings, surgical outcomes, and prognosis will be collected.
Contact and invasion of iCCA with glissonean pedicle (GP) is evaluated by contrast-enhanced CT or MRI.
Definitions of iCCA-Glissonean pedicle contact and invasion:
Negative: Tumor and GP are clearly separated or normal tissue is seen between tumor and GP.
Positive: Tumor contacts with GP at any point. Tumor clearly invades GP. Tumor and GP are separated but the surrounding invasion extends into GP. Tumor and GP are separated but there is deformation in GP near the tumor and peripheral bile duct extension. An investigator can use CENTRAL REVIEW.
Management information
Registered date
| 2025 | Year | 05 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066040
