Guidance
3 Committee considerations
The evidence
3.1 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 10 sources, which was discussed by the committee. The evidence included 1 systematic review and meta-analysis, 2 randomised controlled trials, 1 non-randomised comparative study, 5 case series and 1 case report. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: relief of biliary obstruction, reduction in bilirubin levels, reintervention rates, stent patency and improvement in quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, infection (including peritonitis), bile leak and stent migration.
3.4 Patient commentary was sought but none was received.
Committee comments
3.5 The committee noted that there is more than 1 available device for this procedure.
3.6 The committee was informed that this is a complex procedure that requires significant training in endoscopic ultrasound.
3.7 The committee noted that this procedure is most often used after a failed endoscopic retrograde cholangiopancreatography (ERCP).
3.8 The committee was informed that this procedure usually involves stent placement via the duodenum.
3.9 The committee noted that most of the evidence for this procedure was from people with malignant disease.
3.10 The committee was informed that the decision to do ERCP or endoscopic ultrasound-guided biliary drainage may be made at the time of the procedure.
ISBN: 978-1-4731-5140-6