Recommendations on maximising the clinical value of tissue in the management of patients with intrahepatic cholangiocarcinoma

Background & AimsPatients with intrahepatic cholangiocarcinoma can now be managed with targeted therapies directed against specific molecular alterations. Consequently, tissue submitted to a pathology department must yield molecular information in addition to a diagnosis or, in resection specimens, staging information. The pathologist's role reporting these specimens has therefore changed to accommodate such personalised approaches. Methods: We have developed recommendations and guidance for pathologists by undertaking a systematic review of existing guidance to generate candidate statements followed by an international Delphi process. 59 pathologists from 28 countries in 6 continents rated statements mapped to all elements of the specimen pathway from receipt in the pathology department to authorisation of the final written report. A separate survey of 'end-users' of the report including surgeons, oncologists, and gastroenterologists was undertaken to evaluate what information should be included in the written report to enable appropriate patient management. Results: 48 statements reached consensus for inclusion in the guidance including 10 statements about the content of the written report that also reached consensus by the 'end-user' participants. A reporting proforma to allow easy inclusion of the recommended data points is provided. Conclusions: These guiding principles and recommendations provide a framework to allow pathologists reporting intrahepatic cholangiocarcinoma to maximise the informational yield of specimens required for personalised patient management.Impact and implicationsBiopsy or resection lesional tissue from intrahepatic cholangiocarcinoma must yield information about the molecular abnormalities within the tumour that define suitability for personalised therapies in addition to a diagnosis and staging information. Here, we have developed international consensus guidance for pathologists that report such cases using a Delphi process that sought the views of both pathologists and 'end-users' of pathology reports. The guidance highlights the need to report cases in a way that preserves tissue for molecular testing and emphasises that reporting requires interpretation of the histological features within the broader clinical and radiological context. The guidance will allow pathologists to report cases of intrahepatic cholangiocarcinoma in a uniform manner that maximises the value of the tissue received to facilitate optimal multidisciplinary patient management.