Advice

Summary

Summary

The SpyGlass system is designed for the diagnostic and therapeutic management of biliary system disease. It is intended to be used when standard techniques are unsuccessful or inappropriate. Outcomes from 9 prospective cohort studies have been reported, including procedural success, diagnostic accuracy and inter‑observer agreement. The cost of the SpyGlass system is not available.

Product summary and likely place in therapy

  • The SpyGlass is a visualisation and intervention system that is used for the diagnostic and therapeutic management of indeterminate strictures and large stones of the biliary system when standard endoscopic retrograde cholangiopancreatography (ERCP) is unsuccessful or considered inappropriate.

  • Unlike standard ERCP, the SpyGlass is a single‑operator system designed to visualise and facilitate access to the biliary ducts during both diagnostic and therapeutic procedures.

  • The SpyGlass system is intended for use in endoscopic units which have both the equipment and expert staff to carry out ERCP. The intended user is a clinician trained in ERCP endoscopy.

Effectiveness and safety

  • The published evidence summarised in this briefing comes from 9 prospective cohort studies involving a total of 629 people.

  • Three of the 9 studies (n=297, 75 and 64) investigated the procedural success of cholangioscopy with the SpyGlass to visualise the target lesions, collect adequate biopsy specimens and remove biliary stones. The studies reported overall success rates ranging from 83.3% to 93.3%.

  • Four studies (n=52, 40, 36 and 11) investigated the diagnostic accuracy of SpyGlass cholangioscopy and SpyBite‑targeted biopsies in people with indeterminate biliary strictures. They reported overall accuracy rates of 88.0% to 94.0%.

  • One study (n=38) investigated the level of inter‑observer agreement during cholangioscopy with the SpyGlass. The observers had only slight agreement on their presumed final diagnosis based on SpyGlass visualisation.

  • The incidence of adverse events in these studies ranged from 4.8% to 13.5%, which is comparable to that of standard ERCP for complex procedures. The adverse events mainly included post‑procedure episodes of cholangitis and pancreatitis.

Technical factors

  • The SpyGlass is a modification of the 'mother‑baby' cholangioscopy technique, which involves a 'baby' endoscope with disposable and non‑disposable components.

Cost and resource use

  • No publicly‑available information exists on the purchase cost of the SpyGlass.

  • There is very limited published evidence on cost and resource consequences of using the SpyGlass. A conference poster presentation reported the cost per patient to be £1443.