Utility of Bio-Degradable Bile Duct Stents Following Bile Leaks and Pre-Operative Stone Clearance: International, Prospective, Multi-Centre, Observational Cohort Study

Author(s): Suresh Vasan Venkatachalapathy, Martin W James, Deepak Joshi, Gavin Johnson, Simon Philpotts, Manu Nayar, Matthew Huggett, Danny Cheriyan, Christopher Clarke, Damilola Olajide, Aloysious D Aravinthan, Guruprasad P Aithal

Introduction: Endoscopic retrograde cholangio-pancreatography (ERCP) and biliary stenting provides faster resolution of bile leaks post-cholecystectomy, while its use pre-cholecystectomy remains controversial. In both scenarios, patients frequently need repeat procedures for removal of stent. Novel biodegradable stents may prevent the need for repeat procedures. We tested the utility of these in a prospective multi-centre observational study. Methods: Consecutive patients referred for ERCP, either for treatment of bile leaks or removal of bile duct stones (pre-cholecystectomy), were recruited from 6 tertiary centres in the United Kingdom and Ireland between December 2020 and August 2022. The primary objective was to assess the clinical success of biliary drainage with biodegradable stents. The secondary objectives were to assess the technical success, complications, patient discomfort, stent visibility on fluoroscopy, stent degradation, quality of life (QoL) before and after the procedure, and the health economics of these stents. Results: Sixty-five patients were included. The stent placement was feasible in all patients with a clinical success of 96.8%. Forty-three patients (88%) had complete stent degradation, 2 (4%)-partial degradation, and 4 (8%)-no degradation at day-90. QoL measure improved by 14-fold during 90 day follow up – 17-fold improvement in the bile leak and 13-fold in the bile duct stone cohort. Elimination of repeat procedures would result in a cost saving of £332 per patient for all indications. Conclusion: Biodegradable stents are associated with excellent clinical success rate and improvement in QoL post- procedure. This is also associated with cost savings to health care providers.