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ASSESSMENT OF PREOPERATIVE DIAGNOSTIC ACCURACY OF MULTIDETECTOR-ROW COMPUTED TOMOGRAPHY (MDCT) FOR RESECTABLE BILIARY CANCER: MULTI-INSTITUTIONAL VALIDITY STUDY IN JAPAN
Satoshi Nara*25, Kazuaki Shimada25, Katsuhiko Uesaka1, Masaru Konishi2, Masayuki Ohtsuka3, Satoshi Hirano4, Michiaki Unno5, Hiroaki Yanagimoto6, Tatsuya Nomura7, Naohiro Sata8, Hiroshi Wada9, Etsuro Hatano10, Hirohiko Sakamoto11, Tetsuo Ohta12, Yasuhiro Fujino13, Soichiro Morinaga14, Munenori Tahara15, Yoshiyasu Ambo16, Koji Ohta17, Tsutomu Fujii18, Hirofumi Shirakawa19, Hiroaki Nagano20, Atsushi Miyamoto21, Kazuhisa Takeda22, Keishi Sugimachi23, Junji Furuse24
1Shizuoka Cancer Center Hospital, Shizuoka, Japan; 2National Cancer Center Hospital East, Kashiwa, Japan; 3Department of General Surgery, Chiba University, Chiba, Japan; 4Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, Sapporo, Japan; 5Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan; 6Department of Surgery, Kansai Medical University, Hirakata, Japan; 7Department of Surgery, Niigata Cancer Centre Hospital, Niigata, Japan; 8Department of Surgery, Jichi Medical University, Shimono, Japan; 9Department of Surgery, Osaka International Cancer Institute, Osaka, Japan; 10Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan; 11Saitama Cancer Center Hospital, Saitama, Japan; 12Department of Gastroenterologic Surgery, Kanazawa University, Kanazawa, Japan; 13Hyogo Prefectural Cancer Center, Akashi, Japan; 14Department of Hepato-Biliary and Pancreatic Surgery, Kanagawa Cancer Center, Yokohama, Japan; 15Sapporo Kosei Hospital, Sapporo, Japan; 16Teine Keijinkai Hospital, Sapporo, Japan; 17Shikoku Cancer Center, Matsuyama, Japan; 18Department of Surgery and Science, University of Toyama, Toyama, Japan; 19Tochigi Cancer Center, Utsunomiya, Japan; 20Division of Hepato-Biliary-Pancreatic Surgery and liver transplantation, Yamaguchi University Hospital, Yamaguchi, Japan; 21National Hospital Organization Osaka National Hospital, Osaka, Japan; 22Yokohama City University Medical Center, Yokohama, Japan; 23Kyushu Cancer Center, Fukuoka, Japan; 24Department of Medical Oncology, Kyorin University, Mitaka, Japan; 25Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Tokyo, Japan

Background: Multidetector-row computed tomography (MDCT) is recommended as a standard preoperative examination for resectable biliary cancer. However, its diagnostic accuracy has not been well established. Hepatobiliary and Pancreatic Oncology Group (HBPOG) of the Japan Clinical Oncology Group (JCOG) conducted a multi-institutional retrospective study to validate the accuracy of MDCT diagnosis before initiating a future clinical trial of preoperative therapy for resectable biliary cancer. The aim of the study was to investigate the risk of overdiagnosis through which patients with early stage disease may receive unnecessary preoperative therapy (UMIN000030917).
Patients and methods: We retrospectively reviewed the records of 1,237 patients who underwent surgery for biliary cancer at 24 Japanese hospitals between 2014 and 2016. All patients underwent preoperative MDCT (slice ≤5mm) within 60 days prior to surgery. Based on the data of the biliary and liver cancer registry in Japan, candidates of the preoperative therapy trial were defined as stage II-IVA for perihilar cholangiocarcinoma, stage IB-III for distal cholangiocarcinoma, stage IIIA-IVA for gallbladder carcinoma, stage IIA-III for ampullary carcinoma, and stage III-IVA for intrahepatic cholangiocarcinoma according to Japanese classification of biliary tract cancers (6th edition) and primary liver cancers (6th edition). The primary endpoint was the proportion of pathological stage I (stage IA for distal cholangiocarcinoma) patients who were diagnosed by MDCT with a biliary cancer that fulfilled the inclusion criteria of the preoperative therapy trial, which we predicted to be ≤10% for ampullary carcinoma, and ≤5% for others. The secondary endpoints were sensitivity and specificity of MDCT to diagnose: 1) A biliary tract cancer that pathologically fulfilled the inclusion criteria of preoperative therapy trial; 2) lymph node metastasis; and 3) R1 (invasive cancer) or R2 resection.
Results: The number of analyzed patients with perihilar, distal, gallbladder, ampullary and intrahepatic (cholangio-) carcinomas were 298, 355, 190, 201, and 128, respectively. The primary endpoints were 5.4%, 4.0%, 2.2%, 39.3%, and 3.1% in perihilar, distal, gallbladder, ampullary and intrahepatic (cholangio-) carcinomas, respectively. Diagnostic accuracy was not significantly improved even in patients with MDCT slices of 1 mm or less. The secondary endpoints are shown in Table 1.
Conclusion: The accuracy of MDCT was validated in patients with perihilar, distal, gallbladder, and intrahepatic (cholangio-) carcinoma, but not in patients with ampullary carcinoma. Additional examinations other than MDCT may be necessary to improve diagnostic accuracy for ampullary carcinoma.

Secondary endpoints
 Perihilar cholangiocarcinomaDistal cholangiocarcinomaGallbladder carcinomaAmpullary carcinomaIntrahepatic cholangiocarcinoma
Sensitivity of MDCT to diagnose a biliary cancer that pathologically fulfilled the inclusion criteria of the preoperative therapy trial0.9870.9310.5750.4930.780
Specificity of MDCT to diagnose a biliary cancer that pathologically fulfilled the inclusion criteria of the preoperative therapy trial0.1430.3260.9410.7860.306
Sensitivity of MDCT to diagnose lymph node metastasis0.3070.2550.4030.2660.378
Specificity of MDCT to diagnose lymph node metastasis0.8610.8360.9420.9260.904
Sensitivity of MDCT to diagnose R1 (invasive cancer) or R2 resection0.1970.2310.1300.5000
Specificity of MDCT to diagnose R1 (invasive cancer) or R2 resection0.9160.9880.9941.00.991


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