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-\r\ntures (dMBSs) are a common indication for endoscopic\r\nretrograde cholangiopancreatography (ERCP). The present\r\nstudy aimed to evaluate adherence of Italian endoscopic\r\ncenters to European Society of Gastrointestinal Endoscopy\r\n(ESGE) guidelines on management of dMBS.\r\nPatients and methods This prospective cohort, observa-\r\ntional, multicenter study was promoted by the Italian Socie-\r\nty of Digestive Endoscopy. All consecutive patients with\r\ndMBS were included in the registry. Clinical and technical\r\ndata were recorded. Clinical follow-up was performed at 7\r\nBackground and study aims\r\nDistal malignant biliary stricture (dMBS) is often seen in various\r\ncancers, particularly pancreatic cancer [1, 2, 3]. Endoscopic\r\nretrograde cholangiopancreatography (ERCP) is the preferred\r\nmethod for biliary drainage in these patients, with plastic\r\nstents (PSs) and self-expandable metal stents (SEMSs) being\r\nused [4, 5]. PSs are easily removable but prone to migration\r\nand early occlusion [6, 7]. SEMSs are available in three types:\r\nuncovered (U-SEMS), partially-covered (PC-SEMS), and fully-\r\ncovered (FC-SEMS) [8]. U-SEMSs have low migration risk but\r\nhigher risk of tissue ingrowth impeding their removability,\r\nwhereas PC-SEMSs and FC-SEMSs are removable but risk of mi-\r\ngration is increased [9]. Moreover, controversial results regard-\r\ning risk of post-ERCP cholecystitis due to cystic duct occlusion\r\nby covered SEMSs have been published [10, 11, 12].\r\nIn 2018, the European Society of Gastrointestinal Endoscopy\r\n(ESGE) published updated guidelines on endoscopic biliary\r\nstenting. The following list summarizes the statements regard-\r\ning dMBS [13]. In summary, ESGE recommended use of SEMSs\r\nto treat dMBS in both preoperative and palliative settings [13],\r\nwithout performing routine biliary sphincterotomy and avoid-\r\ning U-SEMS if a diagnosis of malignancy was not yet obtained.\r\nThese recommendations are based on the clear advantage of\r\nSEMSs over PSs (lower rate of endoscopic reintervention, long-\r\ner patient survival, lower risk of stent dysfunction/cholangitis)\r\n[14, 15]. However, the choice among the different types of\r\nSEMSs is still debated. A recent meta-analysis, including 13\r\nstudies (7 randomized controlled trials [RCTs]) and 2,239 pa-\r\ntients, showed no statistically significant difference in the sur-\r\nE2 and 30 days, and then every 3 months. Adherence to the\r\neight ESGE recommendations (defined as full-, intermedi-\r\nate- and poor-adherence if > 85%, ≥ 65% to ≤85%, and\r\n< 65%, respectively) was considered the primary outcome.\r\nResults Seventeen Italian endoscopy centers were includ-\r\ned. Between January 2020 and January 2022, 827 patients\r\nwere included. Full adherence to the guidelines was report-\r\ned for post-ERCP acute pancreatitis prophylaxis, retreat-\r\nments, and preoperative biliary drainage. Intermediate\r\nadherence was reported for type of stent used in palliative\r\ndrainage (85% SEMS and 15% plastic stents). Poor adher-\r\nence was reported for type of stent used in preoperative\r\ndrainage (56% self-expandable metal stents [SEMSs]), avail-\r\nability of pathological diagnosis in case of U-SEMS place-\r\nment (45% of U-SEMSs placed without pathologically diag-\r\nnosis), antibiotic prophylaxis (70.6%), and sphincterotomy\r\n(88%).\r\nConclusions Adherence to ESGE guidelines needs to be\r\nimproved in specific areas, including excessive use of plastic\r\nstents, use of U-SEMS without pathological diagnosis, and\r\nroutine performance of sphincterotomy and use of antibio-\r\ntic prophylaxis. (ClinicalTrials.gov ID: NCT05761496)