A new biodegradable stent in bilio-pancreatic diseases: a prospective multi-center feasibility study

ABSTRACT

Introduction: biodegradable stents of various designs arereportedly used in pancreato-biliary conditions with promising results. Their major advantage is the avoidance ofrepeat endoscopic procedure for stent removal, therebyreducing overall costs and endoscopic retrograde cholangiopancreatography (ERCP) associated adverse events. Theaim of the study was to evaluate the feasibility and safetyof a new biodegradable stent in patients with pancreato-biliary diseases.Methods: a prospective multicenter pilot study was performed. All consecutive patients ≥ 18 years old whounderwent biliary or pancreatic stenting using the new biodegradable Archimedes stent were included in the study.There were three biodegradation profiles. Technical andclinical success and feasibility and safety were assessedduring a pre-established follow-up schedule.Results: fifty-three patients (mean age: 48.54 ± 19.29, 66 %male) with biliary (n = 29, 54.7 %) or pancreatic (n = 24,45.3 %) indications were included. The distribution of stentsused according to degradation properties were as follows:fast (n = 11, 20.8 %), medium (n = 16, 30.2 %) and slow (n =26, 49.1 %). The technical and clinical success were 100 %and 77.8 %, respectively. Thirty-five patients were followedfor a median of 26 weeks (range: 4-56, 66 %). There werenine procedure-related adverse events (17 %), all mild,including one uneventful stent-related event (externalmigration).Conclusion: the biodegradable Archimedes stent placementis feasible and safe in pancreato-biliary diseases. (AU)