臨床研究等提出・公開システム

Date of registration	June. 20, 2025
Last modified on	June. 20, 2025
Trial ID	jRCT1030250176

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 (Cube-PHC)
Public Title	MRI (Cube) assessment of tumor spread in perihilar cholangiocarcinoma after biliary stent placement (Cube-PHC)

Contact for Scientific Queries	Name	Abe Yuta
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo
	Telephone	+81-3-3353-1211
	E-mail	abey3666@gmail.com
Contact for Public Queries	Name	Sonoda Keita
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo
	Telephone	+81-3-3353-1211
	E-mail	ksonoda622@keio.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 01, 2015
Actual date of first enrollment		Nov. 01, 2015
Target sample size		100
Study Type		Observational
Key inclusion & exclusion 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	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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Perihilar cholangiocarcinoma
Health Condition(s) Keyword		Perihilar cholangiocarcinoma
Health Condition(s) Code		D018285
Primary Outcome(s)		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 Outcome(s)		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.

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Keio University School of Medicine, An Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-5363-3503
E-Mail	med-nintei-jimu@adst.keio.ac.jp
Approval Status	Approval
Date of approval	April. 03, 2012

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none