Endoscopic bipolar radiofrequency ablation for malignant biliary obstruction

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 6 randomised controlled trials, 1 non-randomised comparative study and 1 systematic review and meta-analysis. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in table 5 of the overview.

The professional experts and the committee considered the key efficacy outcomes to be: improvement in quality of life, reduction in biliary obstruction, stent patency, and reduced mortality and morbidity.

The professional experts and the committee considered the key safety outcomes to be: biliary tract perforation, biliary track infection and inflammation, and pain.

One patient organisation submission was received. Patient commentary was sought but none was received.

The committee was informed that this procedure can be done by clinicians who are experienced in endoscopic retrograde cholangiopancreatography.

There is more than 1 device available for this procedure.

There are conflicting results on whether the procedure affects overall survival. Randomised controlled trials done in Germany, the Czech republic and South Korea show no effect, while 2 randomised controlled trials done in China show improved overall survival. But the effect seen is small and the reason for it is not well understood. Also, overall survival could be affected by many factors, such as type, site and stage of tumour, and systemic treatment. There is also a lack of evidence showing that this procedure improves quality of life.

The effect of this procedure in relieving biliary obstruction may enable chemotherapy to be offered to people who otherwise would not be able to have it. But its effect on stent patency is uncertain.