Safety and economic analysis of selective histopathology following cholecystectomy: multicentre, prospective, cross-sectional FANCY study

Abstract

Background There is ongoing debate concerning the necessity of routine histopathological examination following cholecystectomy. In order to reduce the pathology workload and save costs, a selective approach has been suggested, but evidence regarding its oncological safety is lacking. Methods In this multicentre, prospective, cross-sectional study, all gallbladders removed for gallstone disease or cholecystitis were systematically examined by the surgeon for macroscopic abnormalities indicative of malignancy. Before sending all specimens to the pathologist, the surgeon judged whether histopathological examination was indicated. The main outcomes were the number of patients with hypothetically missed malignancy with clinical consequences (upper limit two-sided 95 per cent c.i. below 3:1000 considered oncologically safe) and potential cost savings of selective histopathological examination. Results Twenty-two (2.19:1000) of 10 041 specimens exhibited malignancy with clinical consequences. In case of a selective policy, surgeons would have held back 7846 of 10041 (78.1 per cent) gallbladders from histopathological examination. Malignancy with clinical consequences would have been missed in seven of 7846 patients (0.89:1000, upper limit 95% c.i. 1.40:1000). No patient benefitted from the clinical consequences, while two were harmed (futile additional surgery). Of 15 patients in whom malignancy with clinical consequences would have been diagnosed, one benefitted (residual disease radically removed), two potentially benefitted (palliative systemic therapy), and four experienced harm (futile additional surgery). Estimated cost savings established by replacing routine for selective histopathological examination were €703 500 per 10 000 patients. Conclusion Selective histopathological examination following cholecystectomy is oncologically safe and could reduce pathology workload, costs, and futile re-resections.

Comment on: safety and economic analysis of selective histopathology following cholecystectomy: multicentre, prospective, cross-sectional FANCY study

“…The low rate of malignancy found in the FANCY study (0.22 per cent) implies that in a statistical sense, the chance of missing malignancy within a selective histopathological examination approach is extremely low 1 . Despite a small rate of cancer being missed of 0.00089 per cent that was not statistically significant, a missed cancer diagnosis is still a significant and tangible risk for the patient with large potential medicolegal implications for clinicians.…”

“…We read with great interest the results of the FANCY study by Bastiaenen et al 1 ., and commend the authors on work that can produce large cost and safety benefits for general surgical systems. Overwhelming evidence was obtained demonstrating that selective histopathological examination following cholecystectomy is not only safe for the patients involved but potentiates significant economic benefits for healthcare.…”