UMIN-CTR Clinical Trial

Basic information
Public title	The Assessment of Preoperative Diagnostic Accuracy of Multidetector-row computed tomography (MDCT) for Resectable Biliary Cancer
Acronym	The Assessment of Preoperative Diagnostic Accuracy of Multidetector-row computed tomography (MDCT) for Resectable Biliary Cancer (Pre-BICA)
Scientific Title	The Assessment of Preoperative Diagnostic Accuracy of Multidetector-row computed tomography (MDCT) for Resectable Biliary Cancer
Scientific Title:Acronym	The Assessment of Preoperative Diagnostic Accuracy of Multidetector-row computed tomography (MDCT) for Resectable Biliary Cancer (Pre-BICA)
Region	Japan

Condition
Condition	Biliary cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To validate the accuracy of MDCT diagnosis of the pathological TNM stage of biliary cancer, that fulfills the inclusion criteria of the future phase III trial (preoperative therapy + surgery vs. surgery alone) planned in HBP group of Japan Clinically Oncology Group (JCOG)
Basic objectives2	Others
Basic objectives -Others	Validation study
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The proportion of pathological stage I (stage IA in distal bile duct cancer) among the patients who were diagnosed with a biliary cancer that fulfills the inclusion criteria of preoperative therapy trial on MDCT
Key secondary outcomes	Sensitivity and specificity of MDCT to diagnose a biliary cancer that fulfills the inclusion criteria of preoperative therapy trial; Sensitivity and specificity of MDCT to diagnose the lymph node metastasis; Sensitivity and specificity of MDCT to diagnose the R1 (invasive cancer) or R2 resection

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 who fulfills all the following inclusion criteria 1) The patient is diagnosed with adenocarcinoma of biliary tract by pathological examination of resected or pre-/intra- operative biopsied specimen (The pathological diagnosis is conducted according to the sixth edition of General Rules for the Clinical and Pathological Study of Primary Liver Cancer in intrahepatic bile duct cancer, and according to the sixth edition of Classification of Biliary Tract Cancers in other biliary cancers) 2) The patients who underwent the contrast-enhanced multidetector-row computed tomography (MDCT) examination (5mm or less slice, regardless the presence or absence of biliary drainage) within 60 days before operation, and were diagnosed with resectable biliary cancer (without distant metastasis and R0/1 resection possible) 3) The patients underwent laparotomy with the intent of tumor resection between 2014 and 2016 in the institution of JCOG (including not only the resected cases but also the unresected cases) 4) The patients do not have a past history of either preoperative chemotherapy or radiation therapy in the upper abdomen
Key exclusion criteria	1) The patients with intrahepatic bile duct cancer with the macroscopic appearance of periductal infiltrating type, intraductal-growth type or predominant type of either, because General Rules for the Clinical and Pathological Study of Primary Liver Cancer is not applied to these types. 2) The patients who underwent preoperative image examination only in other hospital 3) The patents who have other active cancers at the time of operation
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Kazuaki Middle name Last name Shimada
Organization	National Cancer Center Hospital
Division name	Hepatobiliary and Pancreatic Surgery Division
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL	03-3542-2511
Email	kshimada@ncc.go.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Nara
Organization	National Cancer Center Hospital
Division name	Hepatobiliary and Pancreatic Surgery Division
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL	03-3542-2511
Homepage URL
Email	sanara@ncc.go.jp

Sponsor
Institute	The Hepatobiliary and Pancreatic Oncology (HBPO) Group of the Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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 National Cancer Center Hospital
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.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	札幌厚生病院（北海道） 北海道大学病院（北海道） 手稲渓仁会病院（北海道） 東北大学病院（宮城県） 栃木県立がんセンター（栃木県） 自治医科大学（栃木県） 埼玉県立がんセンター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉大学医学部（千葉県） 国立がん研究センター中央病院（東京都） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 富山大学附属病院（富山県） 金沢大学医学部（石川県） 静岡県立静岡がんセンター（静岡県） 大阪国際がんセンター（大阪府） 国立病院機構大阪医療センター（大阪府） 関西医科大学附属病院（大阪府） 兵庫医科大学（兵庫県） 兵庫県立がんセンター（兵庫県） 山口大学医学部附属病院（山口県） 国立病院機構四国がんセンター（愛媛県） 国立病院機構九州がんセンター（福岡県）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 15 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	1237
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	Completed
Date of protocol fixation	2017 Year 11 Month 30 Day
Date of IRB	2017 Year 12 Month 14 Day
Anticipated trial start date	2017 Year 12 Month 26 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a multi-institutional retrospective observational study

Management information
Registered date	2018 Year 01 Month 21 Day
Last modified on	2019 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035302