Cost-Benefit Analysis and Resource Implications of Endoscopic Ultrasound-Guided Confocal Endomicroscopy in Pancreatic Cysts

Background and Aims: EUS-guided needle-based confocal laser endomicroscopy (nCLE) improves the diagnostic accuracy of pancreatic cystic lesions (PCLs) but concerns regarding its expense have limited widespread adoption of this technology. We conducted a cost-benefit analysis to assess the healthcare resource implications of adding EUS-nCLE to the standard of care (SOC) management of PCLs. Methods: A post-hoc analysis of a prospective study (2015-2018) evaluating EUS-nCLE for the diagnosis of PCLs was performed. The SOC diagnosis was based on clinical history, PCL morphology, and cyst fluid analysis. A minimum of 5-years surveillance was included, the cost of EUS and MRI/MRCP was derived from institutional billing data (US$), and the total hospital costs (adjusted for inflation) for pancreatic operations were derived from the National (US) Readmission Database. Results: A reference diagnosis was available in 93 subjects (mean cyst size = 36.4 ± 15.7 mm; surgical histopathology, n = 67 and diagnostic molecular markers in cyst fluid, n = 26). SOC and nCLE were discordant in 13 (14%) subjects. The addition of nCLE led to 11 subjects being clinically down-staged from mucinous to non-mucinous not warranting surgery (total cost savings = $1,080,418), 1 subject upstaged from non-mucinous to mucinous, warranting surgical resection (cost savings of 5-years surveillance: $46,200), and 1 subject incorrectly classified as non-mucinous (cost excess of 5-years surveillance: $46,200). Overall, the addition of nCLE led to a net savings of $ 442,438 (mean: $ 4757.40/patient) for this cohort. Conclusion: EUS-nCLE is potentially cost-beneficial in the management of PCLs (≥3 cm) by preventing at least one unnecessary pancreatic surgery for every 10 subjects undergoing evaluation by current practices. ClinicalTrials.gov number: NCT02516488.