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First author/year | Spectrum of patients | Consecutive or random selection of patients | Reference standard | Application of reference standard regardless of indexed test | Enough explanation of the index test to ensure reproducibility | Independent blind comparison between index test and reference standard |
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Fritscher-Ravens, 2001 [6] | Patients with obstructive jaundice and hilar lesions | Yes | Histopathology | Yes | Yes | Yes |
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Kluge, 2001 [7] | 26 patients with CCa, 8 patients with benign bile duct stenosis, and 20 controls | No | Histopathology | Yes | Yes | Yes |
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Kato, 2002 [8] | Patients with bile duct cancer | N/A | Histopathology | Yes | Yes | Yes |
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Kim, 2003 [9] | Patients with intrahepatic CCa | N/A | Histopathology or clinical and radiological findings | Yes | Yes | No blinding |
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Anderson, 2004 [10] | Patients suspected of CCa or gallbladder carcinoma | Yes | Histopathology or cytopathology | Yes | Yes | No information regarding blinding |
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Reinhardt, 2005 [11] | Patients with extrahepatic bile duct strictures on endoscopic retrograde cholangiography | Yes | Histopathology or cytopathology and imaging criteria and follow-up | No (patients with negative PET and cytology did not undergo surgery) | Yes | No |
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Wakabayashi, 2005 [12] | Patients with suspicious malignant biliary stricture | N/A | Histopathology (biopsy and surgical findings) | Yes | Yes | N/A |
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Petrowsky, 2006 [13] | Patients with suspected or proven CCa or gallbladder cancer | Yes | Histopathology | Yes | Yes | Yes |
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Prytz, 2006 [14] | Patients with primary sclerosing cholangitis within 2 weeks after listing for liver transplantation and with no evidence of malignancy on CT, magnetic resonance imaging, or ultrasonography | Yes | Histology of explanted livers | Yes | Yes | Yes |
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Nishiyama, 2007 [15] | Patients with biliary stricture who underwent PET imaging | Yes | Histopathology or cytology | Yes | Yes | Yes |
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Corvera, 2008 [16] | Patients with clinical diagnosis of biliary tract cancers | N/A | Histopathology | Yes | Yes | No |
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Furukawa, 2008 [17] | Patients with suspected extrahepatic biliary cancers (bile duct dilatation and/or mass lesions detected by ultrasonography and CT) | N/A | Histopathology and follow-up | Yes | Yes | No (no blinding) |
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Kim, 2008 [18] | Patients with suspected CCa | Yes | Histopathology or follow-up | Yes | Yes | Yes |
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Li, 2008 [19] | Patients with clinically suspected or already established diagnosis of hilar CCa | N/A | Histopathology | Yes | Yes | N/A |
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Moon, 2008 [20] | Patients with suspected CCa | Yes | Histopathology, cytopathology, or follow-up | Yes | Yes | Yes |
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Lee, 2010 [21] | Patients with suspected CCa or gallbladder cancer | N/A | Histopathology or follow-up | Yes | Yes | Yes |
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Alkhawaldeh, 2011 [22] | Heterogeneous patients including patients with suspected CCa, patients with positive cytology for CCa, and patients with negative cytology | No | Histopathology or follow-up | Yes | Yes | N/A |
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Kitamura, 2011 [23] | Patients with extrahepatic bile duct cancer | Yes | Histopathology | Yes | Yes | No |
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Ruys, 2011 [24] | Patients highly suspected of hilar CCa | Yes | Histopathology | Yes | Yes | Yes |
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Yamada, 2012 [25] | Patients with diagnosis of cancer of biliary tract | Yes | Histopathology | Yes | Yes | No |
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Albazaz, 2013 [3] | Patients with primary biliary tumors | Yes | Histopathology | Yes | Yes | Yes |
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Choi, 2013 [1] | Patients with suspected extrahepatic malignancy based on imaging studies | Yes | Histopathology or follow-up | Yes | Yes | Yes |
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Lee, 2013 [2] | Patients with confirmed biliary duct or gallbladder cancers | N/A | Histopathology or follow-up | Yes | Yes | N/A |
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