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MRI (Cube) assessment of tumor spread in perihilar cholangiocarcinoma after biliary stent placement

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 - Cube-PHC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1030250176
Enrollment
100
Registered
2025-06-20
Start date
2015-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perihilar cholangiocarcinoma Perihilar cholangiocarcinoma

Interventions

None listed

Sponsors

Abe Yuta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Overall diagnostic accuracy percentage agreement between each imaging modality (Cube and MDCT) and the pathological reference standard across all evaluation points, assessed both before and after EBS placement.

Secondary

MeasureTime frame
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.

Contacts

Public ContactKeita Sonoda

Keio University School of Medicine

ksonoda622@keio.jp+81-3-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026