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Benign biliary strictures refractory to standard bilioplasty treated using polydoxanone biodegradable biliary stents: retrospective multicentric data analysis on 107 patients

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Abstract

Objectives

To assess mid-term outcome of biodegradable biliary stents (BBSs) to treat benign biliary strictures refractory to standard bilioplasty.

Methods

Institutional review board approval was obtained and patient consent was waived. 107 patients (61 males, 46 females, mean age 59 ± 16 years), were treated. Technical success and complications were recorded. Ninety-seven patients (55 males, 42 females, aged 57 ± 17 years) were considered for follow-up analysis (mean follow-up 23 ± 12 months). Fisher’s exact test and Mann–Whitney U tests were used and a Kaplan–Meier curve was calculated.

Results

The procedure was always feasible. In 2/107 cases (2 %), stent migration occurred (technical success 98 %). 4/107 patients (4 %) experienced mild haemobilia. No major complications occurred. In 19/97 patients (18 %), stricture recurrence occurred. In this group, higher rate of subsequent cholangitis (84.2 % vs. 12.8 %, p = 0.001) and biliary stones (26.3 % vs. 2.5 %, p = 0.003) was noted. Estimated mean time to stricture recurrence was 38 months (95 % C.I 34–42 months). Estimated stricture recurrence rate at 1, 2, and 3 years was respectively 7.2 %, 26.4 %, and 29.4 %.

Conclusion

Percutaneous placement of a BBS is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period.

Key Points

• Percutaneous placement of a BBS is 100 % feasible.

• The procedure appears free from major complications, with few minor complications.

• BBSs offer promising results in the mid-term period.

• With a BBS, external catheter/drainage can be removed early.

• BBSs represent a new option in treating benign biliary stenosis.

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Acknowledgments

We thank Prof. Federico Ambrogi of the University of Milan, Italy, for his help in reviewing the statistical analysis of the manuscript. The scientific guarantor of this publication is Mariano Gimenez. The authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article. The authors state that this work has not received any funding. One of the authors has significant statistical expertise. Institutional review board approval was obtained. Written informed consent was waived by the Institutional Review Board. Some study subjects or cohorts have been previously reported in Mauri G, Michelozzi C, Melchiorre F, et al. (2013) Biodegradable biliary stent implantation in the treatment of benign bilioplastic-refractory biliary strictures: preliminary experience. Eur Radiol 23:3304–10. doi: 10.1007/s00330-013-2947-2. Methodology: retrospective, observational, multi-center study.

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Authors and Affiliations

  1. Servizio di Radiologia, IRCCS Policlinico San Donato, Piazza Malan 2, 20097, San Donato Milanese, Milano, Italy

    Giovanni Mauri & Luca Maria Sonfienza

  2. Dipartimento di di Immagini e Scienze Radiologiche, Divisione di Radiologia Interventistica, Istituto Europeo di Oncologia, Milano, Italy

    Giovanni Mauri

  3. Scuola di Specializzazione in Radiodiagnostica, Università degli Studi di Milano, Milano, Italy

    Caterina Michelozzi

  4. Dipartimento di Diagnostica per Immagini, Ospedale San Paolo, Milano, Italy

    Fabio Melchiorre & Gianpaolo Cornalba

  5. Servizio di Radiologia Oncologica e Interventistica, IRCCS Istituto Clinico Humanitas, Rozzano, Milano, Italy

    Dario Poretti & Vittorio Pedicini

  6. S.S. Gastroenterologia Diagnostica e Interventistica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

    Monica Salvetti

  7. Unit of Interventional Radiology, UDIAT Hospital Universitario Parc Tauli, Sabadell, Spain

    Eva Criado & Joan Falcò Fages

  8. Unidad de Cirugia Minimamente Invasiva Guiada por Imagen, Universidad de Zaragoza, Zaragoza, Spain

    Miguel Ángel De Gregorio & Alicia Laborda

  9. Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, Milano, Italy

    Luca Maria Sonfienza

  10. Dipartimento di Scienze della Salute, Università degli Studi di Milano, Milano, Italy

    Gianpaolo Cornalba

  11. Dipartimento di Radiologia-Radilogia Interventistica, Fondazione Poliambulanza-Brescia, Brescia, Italy

    Lorenzo Monfardini

  12. Department of Radiology, University Hospital Brno and Medical Faculty, Masaryk University, Brno, Czech Republic

    Jiri Panek & Tomas Andrasina

  13. Gastrointestinal and HPB Surgery Hospital de Clinicas University of Buenos Aires, DAICIM Foundation, Arenales 1640, 1 piso, Buenos Aires, Argentina

    Mariano Gimenez

Authors
  1. Giovanni Mauri
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  2. Caterina Michelozzi
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  3. Fabio Melchiorre
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  4. Dario Poretti
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  5. Vittorio Pedicini
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  6. Monica Salvetti
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  7. Eva Criado
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  8. Joan Falcò Fages
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  9. Miguel Ángel De Gregorio
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  10. Alicia Laborda
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  11. Luca Maria Sonfienza
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  12. Gianpaolo Cornalba
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  13. Lorenzo Monfardini
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  14. Jiri Panek
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  15. Tomas Andrasina
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  16. Mariano Gimenez
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Corresponding authors

Correspondence to Giovanni Mauri or Mariano Gimenez.

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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 26, 4057–4063 (2016). https://doi.org/10.1007/s00330-016-4278-6

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  • DOI: https://doi.org/10.1007/s00330-016-4278-6

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