Source Digestive Disease Research Centre, Tehran University of Medical Science, Tehran, Iran; Storr Liver Unit, Westmead Millennium Institute, University of Sydney and Westmead Hospital, NSW, Australia.
BACKGROUND AND AIMS: Screening for hepatocellular carcinoma (HCC) is commonly practiced and recommended in published guidelines, but evidence for its efficacy has been controversial. We tested the feasibility of conducting a randomised controlled trial of HCC surveillance in patients with cirrhosis, and followed up those offered screening to detect clinical outcomes.
METHODS: Participation was offered to patients with cirrhosis attending liver clinics at 3 University hospitals. Following discussion, patients received a Decision Aid (DA) that outlined the risks and benefits of surveillance. The proposed screening program comprised ultrasonography 6 monthly and serum alpha-fetoprotein every 3 months. We envisaged 5 groups of patients: those who agreed to randomisation, those choosing non-randomised screening, those wanting continuation of usual care, those who were undecided and those refusing participation.
RESULTS: Among 205 patients, 204 (99.5%) declined randomisation. Of these, 181 (88%) elected for a non-randomised screening program, 10% chose usual care (which typically included ad hoc screening) and two were undecided. Among 176 patients fluent in English communication skills 160/ (91%) preferred non-randomised screening compared to 22/29 (76%) of patients needing an interpreter (p<0.026). Of 173 patients in non-randomised screening followed up for mean 13.5±6.04 months, 3 developed HCC, 2 died from non-liver related causes, and 1 underwent liver transplantation for liver failure. Eighteen of 21 patients in "usual care" received ad hoc screening. A simultaneous survey on the quality of the DA showed that the majority of participants believed that the information provided was unbiased.
CONCLUSIONS: Although a RCT is theoretically ideal for determining the efficacy, efficiency and cost-effectiveness of HCC screening, informed patients prefer surveillance. A randomised study of HCC screening is not feasible when informed consent is imparted.