Objectives: Benign strictures of the bile duct may be difficult to treat endoscopically due to altered bowel anatomy. Furthermore, recurrence of stenosis and symptoms remains high. The aim of the Spanish Prospective Registry BiELLA study was to investigate the safety and efficacy of absorbable stents in the treatment of benign biliary strictures and their outcomes on the medium and long-term follow-up.
Methods: A prospective, multicenter, observational, non-randomized study (the BiELLA study) was conducted from January 2014 to September 2018. One hundred fifty-nine patients with benign biliary strictures, mostly postsurgical, were enrolled for implantation of absorbable biliary stents in the 11 participating Spanish tertiary hospitals. The average patient follow-up was 45.4 ± 15.9 months (range, 12-60 months). The follow-up data included symptoms, biochemical parameters, and ultrasound images at 1, 6, and 12 months and then yearly for up to 60 months.
Results: The immediate technical and clinical success rates were 100%. In all patients, stent placement resulted in improvement of clinical symptoms and biochemical parameters. The primary mean patency for stent was 86.7, 79.6, and 78.9% at 12, 36, and 60 months, respectively (95% CI). Biliary restenosis and occlusion occurred in 40 (26.6%) patients. Of the 40 patients, 18 (12%) patients were treated with a second stent and 22 (14.6%) patients had operative repair of the recurrent strictures. There were no major complications associated with stent implantation.
Conclusions: Implantation of an absorbable polydioxanone biliary stent is safe and effective for treatment of benign biliary strictures refractory to balloon dilatation or other biliary intervention.
Key points: • Percutaneous implantation of biodegradable prostheses for the treatment of benign postsurgical biliary strictures is a safe and effective procedure. • More than 75% of the patients presented patency of the stented biliary tree at 5 years follow-up. • Absorbable stents improved clinical symptoms and signs (jaundice, itching, fever), and laboratory parameters in a few days after stent placement.
Keywords: Absorbable implants; Bile ducts; Biliary tract diseases; Biodegradable plastics; Stents.