UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058006 |
|---|---|
| Receipt number | R000066285 |
| Scientific Title | Diagnostic accuracy of three-dimensional fast spin-echo T2-weighted MRI (Cube) versus multidetector CT for evaluating longitudinal spread of perihilar cholangiocarcinoma before and after endoscopic biliary stenting: a diagnostic study |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2026/01/08 23:14:49 |
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Basic information
Public title
MRI (Cube) assessment of tumor spread in perihilar cholangiocarcinoma after biliary stent placement
Acronym
Cube-PHC
Scientific Title
Diagnostic accuracy of three-dimensional fast spin-echo T2-weighted MRI (Cube) versus multidetector CT for evaluating longitudinal spread of perihilar cholangiocarcinoma before and after endoscopic biliary stenting: a diagnostic study
Scientific Title:Acronym
Cube-PHC
Region
| Japan |
Condition
Condition
Perihila cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective study is to evaluate whether three-dimensional fast spin-echo T2-weighted MRI (Cube) offers diagnostic accuracy and evaluability comparable to, or better than, multidetector computed tomography (MDCT) for assessing longitudinal tumor extension of perihilar cholangiocarcinoma before and after endoscopic biliary stent (EBS) placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall diagnostic accuracyPercentage agreement between each imaging modality (Cube and MDCT) and the pathological reference standard across all evaluation points, assessed both before and after EBS placement.
Key secondary outcomes
Sensitivity, specificity, PPV, and NPV for both Cube and MDCT. Evaluability rate. Inter-reader agreement (Cohen's kappa). Diagnostic accuracy for extrahepatic, perihilar, and intrahepatic bile duct segments.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent surgical resection for perihilar cholangiocarcinoma at Keio University Hospital between January 2016 and December 2024.
2. Pathological confirmation of perihilar cholangiocarcinoma in the resected specimen.
3. Availability of analyzable pre-operative three-dimensional fast spin-echo T2-weighted MRI (Cube) images.
4. When performed, pre-operative multidetector CT (MDCT) images are available and suitable for comparison with Cube MRI.
5. Age more than 18 years at the time of enrollment.
6. Sufficiently complete clinical and imaging data for inclusion in the analysis.
Key exclusion criteria
1. Receipt of pre-operative chemotherapy or chemoradiotherapy.
2. Absence of a pre-operative Cube MRI or images that are unavailable or non-interpretable.
3. Surgical pathology not confirming perihilar cholangiocarcinoma (e.g., distal cholangiocarcinoma or metastatic disease).
4. Stage IVB disease with documented distant metastasis before surgery.
5. Patients younger than 18 years.
6. Critical clinical, imaging, or pathological data missing or incomplete, precluding analysis.
7. Patients who explicitly opted out of retrospective data use.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Abe |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
abey3666@gmail.com
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Sonoda |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
ksonoda622@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Yuta Abe
Funding Source
Organization
Keio University School of Medicine, Department of Surgery
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
Keio University School of Medicine, An Ethics Committee
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
Tel
+81-3-5363-3611
med-rinri-jimu@adst.keio.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 | 29 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40990496/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40990496/
Number of participants that the trial has enrolled
91
Results
The accuracy of MDCT in defining tumor extension was 79.1% without endoscopic biliary stent (EBS) but dropped significantly to 30.2% after EBS placement (p<0.0001). In contrast, Cube MRI showed 77.3% accuracy without EBS and maintained 70.7% accuracy with EBS, which was significantly higher than MDCT with EBS (p<0.0001). The evaluability rate of MDCT decreased from 98% to 37% after stenting, whereas Cube retained an 85% evaluability rate with EBS.
Results date posted
| 2026 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 91 consecutive patients who underwent surgical resection for perihilar cholangiocarcinoma between January 2016 and May 2024, excluding those with preoperative chemotherapy or alternative diagnoses. The median age was 73 years (IQR: 67-77), and 64 patients (70.3%) were male. Bismuth type IV was the most common classification (33 cases). Surgical procedures included right bisectionectomy (n=43) and left bisectionectomy (n=22).
Participant flow
From 154 patients with suspected perihilar cholangiocarcinoma, 18 patients with alternative pathological diagnoses (benign lesions, HCC, etc.) and 38 patients who received preoperative chemoradiotherapy were excluded. Of the 98 pathologically confirmed cases, 6 patients without Cube MRI and 1 patient with a metallic stent were further excluded. Consequently, a final cohort of 91 patients was included in the analysis.
Adverse events
Not applicable. This was a retrospective observational study using medical records.
Outcome measures
Primary Outcome: Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each imaging modality (MDCT and Cube MRI, with and without EBS) for diagnosing longitudinal tumor extension, using pathological findings as the reference standard. Inter-reader agreement (Cohen's kappa) and evaluability rates were also assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study (retrospective cohort / diagnostic accuracy study)
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066285
