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 8 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 randomised controlled trials, 4 non-randomised comparative studies and 1 case series. 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.
3.3 The professional experts and the committee considered the key safety outcomes to be: cholangitis, bile duct damage including perforation and stricture, pancreatitis, bleeding and the need for surgery.
3.4 Patient commentary was sought but none was received.
3.5 The committee was informed that the technique is evolving and different techniques may have different efficacy and safety profiles.
3.6 The committee noted that stone removal can be done as a single procedure using this technique, avoiding the need for several procedures as in some other techniques.
3.7 The committee was informed that in a small number of patients an endoscopic retrograde approach is not possible and the procedure is done through a percutaneous approach, which is a more invasive procedure with a greater risk of complications.
3.8 The committee encourages the establishment of a registry for this procedure.