Advertisement

New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video)

Published:March 04, 2020DOI:https://doi.org/10.1016/j.gie.2020.02.049

      Background and Aims

      In recent years, the feasibility and safety of endoscopic placement of different biodegradable biliary stents have been investigated. New, helicoidally shaped, biliary and pancreatic biodegradable stents have been developed for endoscopic use. Stents are provided in different sizes and with 3 expected speeds of degradation: slow (11 weeks), medium (20 days), and fast (12 days). The aim of this study was to evaluate degradation time, technical outcomes, and safety of these stents.

      Methods

      This was a single-center, prospective, pilot study (August 2018 to January 2019) of consecutive patients with indication for biliary or pancreatic plastic stent positioning during ERCP. The primary outcome was the evaluation of degradation time of the stents, which was controlled by abdominal radiograph. Secondary outcomes were the evaluation of specific stent-related technical features (loadability, pushability, and fluoroscopic visibility) as compared with commonly used plastic stents and adverse events (AEs).

      Results

      Thirty-eight patients (11 women [28.9%]; median age, 68.05 ± 10.74 years) who received 53 biodegradable stents (34 [64.2%] biliary and 19 [35.8%] pancreatic stents) were enrolled in the study. Thirty-five (66%) slow-degrading stents, 6 (11.3%) medium-degrading stents, and 12 (22.6%) fast-degrading stents were used. At time 1, partial degradation of the stents was present in 48 cases (90.6%). Five stents (9.4%) prematurely migrated. At the subsequent time 2 evaluation, complete degradation occurred in 100% of cases. Stent loadability was defined as excellent in all cases. Pushability of the stent was scored as excellent in 48 cases (90.5%), good in 4 cases (7.5%), and fair in 1 case (1.9%). Fluoroscopic visualization was excellent in 11 cases (20.8%), good in 39 cases (73.6%), and fair in 3 (5.6%). Only 1 AE of mild post-ERCP pancreatitis occurred.

      Conclusions

      The results of our study suggest that the biodegradation of the new biliary and pancreatic stents is reliable and in line with expected times and technically successful in a variety of indications. Further randomized multicenter studies are required to validate our preliminary findings. (Clinical trial registration number: NCT03767166.)

      Abbreviations:

      AE (adverse event), PDX (polydioxanone), PEP (post-ERCP pancreatitis)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Siiki A.
        • Rinta-Kiikka I.
        • Sand J.
        • et al.
        A pilot study of endoscopically inserted biodegradable biliary stents in the treatment of benign biliary strictures and cystic duct leaks.
        Gastrointest Endosc. 2018; 87: 1132-1137
        • Siiki A.
        • Vaalavuo Y.
        • Antila A.
        • et al.
        Biodegradable biliary stents preferable to plastic stent therapy in post-cholecystectomy bile leak and avoid second endoscopy.
        Scand J Gastroenterol. 2018; 53: 1-5
        • Siiki A.
        • Sand J.
        • Laukkarinen J.
        A systematic review of biodegradable biliary stents: promising biocompatibility without stent removal.
        Eur J Gastroenterol Hepatol. 2018; 30: 813-818
        • Sabino M.A.
        • Morales D.
        • Ronca G.
        • et al.
        Study of the hydrolytic degradation of a biodegradable copolymer.
        [Spanish] Acta Cientif Venezol. 2003; 54: 18-27
        • Grolich T.
        • Crha M.
        • Novotny L.
        • et al.
        Self-expandable biodegradable biliary stents in porcine model.
        J Surg Res. 2015; 193: 606-612
        • Hair C.S.
        • Devonshire D.A.
        Severe hyperplastic tissue stenosis of a novel biodegradable esophageal stent and subsequent successful management with high-pressure balloon dilation.
        Endoscopy. 2010; 42: E132-E133
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Chandrasekhara V.
        • Khashab M.A.
        • Muthusamy V.R.
        • et al.
        • ASGE Standards of Practice Committee
        Adverse events associated with ERCP.
        Gastrointest Endosc. 2017; 85: 32-47
        • Kumar S.
        • Chandra A.
        • Kulkarni R.
        • et al.
        Forgotten biliary stents: ignorance is not bliss.
        Surg Endosc. 2018; 32: 191-195
        • Bhasin D.K.
        • Rana S.S.
        Biodegradable pancreatic stents: Are they a disappearing wonder?.
        Gastrointest Endosc. 2008; 67: 1113-1116
        • Freudenberg S.
        • Rewerk S.
        • Kaess M.
        • et al.
        Biodegradation of absorbable sutures in body fluids and pH buffers.
        Eur Surg Res. 2004; 36: 376-385
        • Petrtýl J.
        • Bruha R.
        • Horak L.
        • et al.
        Management of benign intrahepatic bile duct strictures: initial experience with polydioxanone biodegradable stents.
        Endoscopy. 2010; 42: E89-E90
        • Mauri G.
        • Michelozzi C.
        • Melchiorre F.
        • et al.
        Benign biliary strictures refractory to standard bilioplasty treated using polydoxanone biodegradable biliary stents: retrospective multicentric data analysis on 107 patients.
        Eur Radiol. 2016; 26: 4057-4063
        • Siiki A.
        • Rinta-Kiikka I.
        • Sand J.
        • et al.
        Biodegradable biliary stent in the endoscopic treatment of cystic duct leak after cholecystectomy: the first case report and review of literature.
        J Laparoendosc Adv Surg Tech A. 2015; 25: 419-422
        • Siiki A.
        • Rinta-Kiikka I.
        • Sand J.
        • et al.
        Endoscopic biodegradable biliary stents in the treatment of benign biliary strictures: first report of clinical use in patients.
        Dig Endosc. 2017; 29: 118-121
        • Dumoulin F.L.
        • Plassmann D.
        Tissue hyperplasia following placement of a biodegradable stent for a refractory esophageal stricture: treatment with argon plasma coagulation.
        Endoscopy. 2012; 44: E356-E357
        • Orive-Calzada A.
        • Alvarez-Rubio M.
        • Romero-Izquierdo S.
        • et al.
        Severe epithelial hyperplasia as a complication of a novel biodegradable stent.
        Endoscopy. 2009; 41: E137-E138
        • Zheng X.
        • Wu J.
        • Sun B.
        • et al.
        Clinical outcome of endoscopic covered metal stenting for resolution of benign biliary stricture: systematic review and meta-analysis.
        Dig Endosc. 2017; 29: 198-210
        • Shatzel J.
        • Kim J.
        • Sampath K.
        • et al.
        Drug eluting biliary stents to decrease stent failure rates: a review of the literature.
        World J Gastrointest Endosc. 2016; 8: 77-85

      Linked Article

      • How far have we come in the design of biliary stents: Are biodegradable stents ready for prime time?
        Gastrointestinal EndoscopyVol. 92Issue 2
        • Preview
          Since the introduction of the first biliary stent in 1980,1 we have witnessed the arrival of numerous stents of various shapes and forms used in managing pancreaticobiliary strictures. In parallel with the advancements in the materials used to make the stents, the stent design has significantly improved as well. In a broad sense, all biliary stents can be plastic or metal. Plastic stents are made of polytetrafluoroethylene, polyethylene, or polyurethane. Metal stents are made of materials that include stainless steel and nitinol (a nickel-titanium alloy).
        • Full-Text
        • PDF