1.1 Evidence on the efficacy of laser lithotripsy for difficult-to-treat bile duct stones is adequate. However, evidence on its long-term safety is limited in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
1.2 Clinicians wishing to do laser lithotripsy for difficult-to-treat bile duct stones should:
Inform the clinical governance leads in their healthcare organisation.
Ensure that patients (and their families and carers, as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Audit and review clinical outcomes of all patients having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
1.3 Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for every patient having this procedure.
Regularly review data on outcomes and safety for this procedure.
1.4 The procedure should only be done in specialised centres with experience of managing difficult-to-treat bile duct stones, and by clinicians with specific training in bile duct stone visualisation and the safe use of laser therapy.
1.5 Patient selection should be done by a multidisciplinary team including a hepatobiliary surgeon and clinicians with expertise in endoscopic retrograde cholangiopancreatography.
1.6 Further research should report long-term safety, including biliary stricture.