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The Assessment of Preoperative Diagnostic Accuracy of Multidetector-row computed tomography (MDCT) for Resectable Biliary Cancer

The Assessment of Preoperative Diagnostic Accuracy of Multidetector-row computed tomography (MDCT) for Resectable Biliary Cancer - The Assessment of Preoperative Diagnostic Accuracy of Multidetector-row computed tomography (MDCT) for Resectable Biliary Cancer (Pre-BICA)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000030917
Enrollment
1000
Registered
2018-02-15
Start date
2017-12-26
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

Biliary cancer

Interventions

None listed

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactSatoshi Nara

National Cancer Center Hospital Hepatobiliary and Pancreatic Surgery Division

sanara@ncc.go.jp03-3542-2511

Outcome results

None listed

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