Presentation (CTI)

OBJECTIVES: This study aimed to support health technology assessment (HTA) scope setting for peroral holmium laser lithotripsy (LL) proposed for pancreaticobiliary stone removal. The initial submission proposed a broader clinical range than existing technologies. This review assessed the comparative effectiveness and safety of LL to guide evidence-based scope determination.
METHODS: A systematic review included 11 comparative studies (3 randomized controlled trials, 8 cohort studies) identified from MEDLINE, Embase, Cochrane Library, and other databases through November 2023. Study quality was appraised using the SIGN checklist. Meta-analyses were stratified by comparator: standard treatment or electrohydraulic lithotripsy (EHL). Outcomes included technical success, adverse events, and procedure time.
RESULTS: The included studies primarily enrolled patients with anatomical challenges or those who had failed prior standard treatments. No studies addressed routine first-line indications where standard treatment was feasible. The pooled technical success rate was significantly higher for LL compared to comparators (RR = 1.13; 95% CI: 1.08, 1.20). Adverse event rates showed no significant difference (RR = 0.99; 95% CI: 0.60, 1.62), and no major complications were reported. Procedure time was significantly shorter than EHL (MD = -21.85 minutes; 95% CI: -25.99, -17.70) but similar to standard treatment. Based on these findings, the Korean HTA approved LL for extrahepatic bile duct stones in patients with anatomical challenges or failed prior treatment, and selectively for intrahepatic and pancreatic duct stones. Evidence was insufficient to support first-line use where standard therapy is feasible.
CONCLUSIONS: This case illustrates how a broad industry proposal was refined through HTA using systematic review findings and clinical guidelines. LL demonstrated safety and effectiveness in selected patient groups where conventional treatments were limited.