Adherence to ESGE guidelines on biliary stenting in malignant distal strictures: Results from a prospective Italian registry

Background and study aims Distal malignant biliary stric- tures (dMBSs) are a common indication for endoscopic retrograde cholangiopancreatography (ERCP). The present study aimed to evaluate adherence of Italian endoscopic centers to European Society of Gastrointestinal Endoscopy (ESGE) guidelines on management of dMBS. Patients and methods This prospective cohort, observa- tional, multicenter study was promoted by the Italian Socie- ty of Digestive Endoscopy. All consecutive patients with dMBS were included in the registry. Clinical and technical data were recorded. Clinical follow-up was performed at 7 Background and study aims Distal malignant biliary stricture (dMBS) is often seen in various cancers, particularly pancreatic cancer [1, 2, 3]. Endoscopic retrograde cholangiopancreatography (ERCP) is the preferred method for biliary drainage in these patients, with plastic stents (PSs) and self-expandable metal stents (SEMSs) being used [4, 5]. PSs are easily removable but prone to migration and early occlusion [6, 7]. SEMSs are available in three types: uncovered (U-SEMS), partially-covered (PC-SEMS), and fully- covered (FC-SEMS) [8]. U-SEMSs have low migration risk but higher risk of tissue ingrowth impeding their removability, whereas PC-SEMSs and FC-SEMSs are removable but risk of mi- gration is increased [9]. Moreover, controversial results regard- ing risk of post-ERCP cholecystitis due to cystic duct occlusion by covered SEMSs have been published [10, 11, 12]. In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) published updated guidelines on endoscopic biliary stenting. The following list summarizes the statements regard- ing dMBS [13]. In summary, ESGE recommended use of SEMSs to treat dMBS in both preoperative and palliative settings [13], without performing routine biliary sphincterotomy and avoid- ing U-SEMS if a diagnosis of malignancy was not yet obtained. These recommendations are based on the clear advantage of SEMSs over PSs (lower rate of endoscopic reintervention, long- er patient survival, lower risk of stent dysfunction/cholangitis) [14, 15]. However, the choice among the different types of SEMSs is still debated. A recent meta-analysis, including 13 studies (7 randomized controlled trials [RCTs]) and 2,239 pa- tients, showed no statistically significant difference in the sur- E2 and 30 days, and then every 3 months. Adherence to the eight ESGE recommendations (defined as full-, intermedi- ate- and poor-adherence if > 85%, ≥ 65% to ≤85%, and < 65%, respectively) was considered the primary outcome. Results Seventeen Italian endoscopy centers were includ- ed. Between January 2020 and January 2022, 827 patients were included. Full adherence to the guidelines was report- ed for post-ERCP acute pancreatitis prophylaxis, retreat- ments, and preoperative biliary drainage. Intermediate adherence was reported for type of stent used in palliative drainage (85% SEMS and 15% plastic stents). Poor adher- ence was reported for type of stent used in preoperative drainage (56% self-expandable metal stents [SEMSs]), avail- ability of pathological diagnosis in case of U-SEMS place- ment (45% of U-SEMSs placed without pathologically diag- nosis), antibiotic prophylaxis (70.6%), and sphincterotomy (88%). Conclusions Adherence to ESGE guidelines needs to be improved in specific areas, including excessive use of plastic stents, use of U-SEMS without pathological diagnosis, and routine performance of sphincterotomy and use of antibio- tic prophylaxis. (ClinicalTrials.gov ID: NCT05761496)