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No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial

  • Interventional
  • Published:
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A Correction to this article was published on 06 July 2020

This article has been updated

Abstract

Objective

To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction.

Methods

Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)–covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival.

Results

A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113–345) for covered stents and 130 days (95% CI 75–185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52–106) and with uncovered stents 92 days (95% CI 60–124) (p = 0.3).

Conclusion

In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival.

Key Points

• Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents.

• Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents.

• Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.

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Change history

  • 06 July 2020

    On request from the Editors, the authors would like to clarify the following: the patient cohorts in the publications ���No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial���.

Abbreviations

ePTFE-FEP:

Expanded polytetrafluoroethylene and fluorinated ethylene propylene

ERCP:

Endoscopic retrograde cholangiopancreatography

HR:

Hazard ratio

MRCP:

Magnetic resonance cholangiopancreatography

PTC:

Percutaneous transhepatic cholangiography

RCT:

Randomized controlled trial

SAE:

Serious adverse event

SEMS:

Self-expandable metal stent

SIR:

Society of Interventional Radiology

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Funding

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

Author information

Authors and Affiliations

  1. Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium

    Elisabeth Dhondt, Peter Vanlangenhove, Lien Van Cauwenberghe & Luc Defreyne

  2. Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium

    Karen Geboes

  3. Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium

    Lisbeth Vandenabeele

Authors
  1. Elisabeth Dhondt
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  2. Peter Vanlangenhove
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  3. Karen Geboes
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  4. Lisbeth Vandenabeele
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  5. Lien Van Cauwenberghe
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  6. Luc Defreyne
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Corresponding author

Correspondence to Elisabeth Dhondt.

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Guarantor

The scientific guarantor of this publication is Prof. Dr. Luc Defreyne.

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.

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 Vandenabeele, L.A.M., Dhondt, E., Geboes, K.P. and Defreyne, L. (2017) Percutaneous Stenting in Malignant Biliary Obstruction Caused By Metastatic Disease: Clinical Outcome and Prediction of Survival According to Tumor Type and Further Therapeutic Options. Acta Gastroenterol Belg 80(2): 249–55.

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• prospective

• randomized controlled trial

• performed at one institution

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Dhondt, E., Vanlangenhove, P., Geboes, K. et al. No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial. Eur Radiol 30, 175–185 (2020). https://doi.org/10.1007/s00330-019-06374-7

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