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Absorbable stents for treatment of benign biliary strictures: long-term follow-up in the prospective Spanish registry

  • Vascular-Interventional
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Abstract

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.

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Abbreviations

ALP:

Alkaline phosphatase

ASA:

American Society of Anesthesiologist

BBDS:

Benign bile duct stenosis

BBS:

Biodegradable biliary stents

BiELLA:

Name of the Spanish prospective registry of biodegradable biliary stents

CEICA:

Ethical Committee of Investigation of Aragon Community

CI:

Confidence interval

ECOG:

Eastern Cooperative Oncology Group

ERCP:

Endoscopic retrograde cholangiopancreatography

Fr:

French

GGT:

Gamma-glutamyl transferase

mGy:

Milligray

PPDX:

Polydioxanone

PTA:

Percutaneous transluminal angioplasty

PTHC:

Percutaneous transhepatic cholangiogram

SERVEI:

Spanish Society of Vascular and Interventional Radiology

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Funding

The authors state that this work has not received any funding.

Author information

Author notes

  1. Miguel Angel De Gregorio and Eva Criado contributed equally to this work.

Authors and Affiliations

  1. Interventional Radiology Research Group (GITMI), University of Zaragoza, Zaragoza, Spain

    Miguel A. De Gregorio, Jose A. Guirola, Enrique Alvarez-Arranz & Sandra Lopez-Minguez

  2. Interventional Radiology Unit, UDIAT-Centre Diagnòstic, Hospital Universitario Parc Tauli Sabadell, Medicine Department Universidad Autónoma de Barcelona, Barcelona, Spain

    Eva Criado

  3. Interventional Radiology Unit, Hospital Universitario Vall d’Hebron, Barcelona, Spain

    Mercedes Pérez-Lafuente

  4. Interventional Radiology Unit, Hospital Clínic i Provincial, Barcelona, Spain

    Marta Barrufet

  5. Interventional Radiology Unit, Hospital Universitario La Ribera, Alzira, Valencia, Spain

    Maria D. Ferrer-Puchol

  6. Interventional Radiology Unit, Hospitales Vithas, Madrid, Spain

    Jose Urbano

  7. Interventional Radiology Unit, Hospital Universitario Virgen de la Salud, Toledo, Spain

    Carlos Lanciego

  8. Interventional Radiology Unit, Hospital Universitario de Cruces, Bilbao, Spain

    Alexander Aguinaga

  9. Interventional Radiology Unit, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain

    Antonio Capel

  10. Interventional Radiology Unit, Hospital Universitario La Paz, Madrid, Spain

    Maria D. Ponce-Dorrego

  11. Interventional Radiology Unit, Hospital de Denia Marina Salud, Alicante, Spain

    Abel Gregorio

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  1. Miguel A. De Gregorio
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Consortia

Spanish group BiELLA (SERVEI)

Corresponding author

Correspondence to Enrique Alvarez-Arranz.

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Guarantor

The scientific guarantor of this publication is Miguel Ángel de Gregorio Ariza.

Conflict of interest

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.

Statistics and biometry

One of the authors has significant statistical expertise.

No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.

Study subjects or cohorts overlap

Some study subjects or cohorts have been previously reported in Treatment of benign lesions of the bile duct via Biodegradable stents. Long-term follow-up. Prospective Multicentric Spanish BIELLA Registry. Poster CIRSE 2019. By E. Criado Paredes.

Methodology

• Prospective

• Observational

• Multicenter study

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De Gregorio, M.A., Criado, E., Guirola, J.A. et al. Absorbable stents for treatment of benign biliary strictures: long-term follow-up in the prospective Spanish registry. Eur Radiol 30, 4486–4495 (2020). https://doi.org/10.1007/s00330-020-06797-7

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  • DOI: https://doi.org/10.1007/s00330-020-06797-7

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