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 5 sources, which was discussed by the committee. The evidence included 3 case series (including 1 abstract reporting safety events) and 2 case reports. It is presented in the summary of key evidence section in the interventional procedures overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: effective biliary drainage, symptom relief and removal of the need for external drainage.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, damage to biliary tree, biliary sepsis and blockage.
3.4 Patient commentary was sought but none was received.
3.5 Most of the evidence considered was for patients with acute calculous cholecystitis who needed persistent external drainage and were unable to have biliary surgery. However, this procedure has also been used in patients with malignant biliary obstruction.
3.6 The committee was informed that an external biliary drainage for 4 weeks to 6 weeks is typically needed before using this procedure.
3.7 Some of the patients treated with this procedure were later able to have definitive surgery.
3.8 The committee noted that there are different stents made of different materials and they might be used for different indications.