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Percutaneous stenting for malignant hilar biliary obstruction: a randomized controlled trial of unilateral versus bilateral stenting

  • Yu-Fei Fu
  • Wen-Jie Zhou
  • Yi-Bing Shi
  • Wei Cao
  • Chi CaoEmail author
Hepatobiliary
  • 13 Downloads

Abstract

Purpose

To compare the clinical outcomes between unilateral and bilateral metal stenting for patients with malignant hilar biliary obstruction (MHO).

Methods

This is a single-center, open-label, prospective, randomized study. Between January 2016 and March 2018, patients with MHO who were treated by percutaneous unilateral or bilateral metal stenting were enrolled. The primary endpoint was stent dysfunction. The secondary endpoints included technical success, clinical success, adverse events, and death. The protocol is registered at ClinicalTrials.gov (identifier: NCT02649712).

Results

A total of 72 patients were randomly grouped for the unilateral (n = 36) or bilateral (n = 36) stenting. The bilateral stenting was performed through the side-by-side technique. While technically, the rates of success of unilateral and bilateral stenting were 83.3% (30/36) in both the cases (P = 1.000), the clinical rates of success in unilateral and bilateral stenting were 90.0% (27/30) and 96.7% (29/30), respectively (P = 0.605). Based on the per-protocol analysis, stent dysfunction was found in 5 and 3 patients in unilateral and bilateral groups, respectively (16.7% vs. 10.0%, P = 0.704). No predictor was observed to influence stent dysfunction. The median cumulative survival in the unilateral group was 122 days and in the bilateral group was 125 days (P = 0.844). We also observed higher levels of post-operative total bilirubin and pre-operative alanine aminotransferase, and the absence of post-operative anticancer treatment as predictors of worse survival.

Conclusion

When compared, the bilateral and unilateral stentings provide a similar clinical effectiveness in patients with MHO.

Keywords

Stent Malignant hilar obstruction Unilateral Bilateral 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study formal consent is not required.

Informed consent

Written informed consent was obtained from all patients.

Research involving animal rights

This article does not contain any studies with animals performed by any of the authors.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Yu-Fei Fu
    • 1
  • Wen-Jie Zhou
    • 2
  • Yi-Bing Shi
    • 1
  • Wei Cao
    • 1
  • Chi Cao
    • 1
    Email author
  1. 1.Department of Medical ImagingXuzhou Central HospitalXuzhouChina
  2. 2.Department of Interventional Radiology, Northern Jiangsu People’s HospitalClinical Medical College of Yangzhou UniversityYangzhouChina

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