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Enteral extended biliary stents versus conventional plastic biliary stents for the treatment of extrahepatic malignant biliary obstruction: a single-center prospective randomized controlled study

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Abstract

Background and aims

The main limitation of plastic stents is the relatively short stent patency due to occlusion. We designed enteral extended biliary stents with lengths of 26 cm (EEBS-26 cm) and 30 cm (EEBS-30 cm) to prolong stent patency. This study aimed to compare patency among EEBS-26 cm, EEBS-30 cm, and conventional plastic biliary stent (CPBS).

Methods

A single-center prospective randomized controlled study was conducted. Eligible patients were randomized into the EEBS-26 cm, EEBS-30 cm, and CPBS groups, respectively. All patients were followed up every 3 months until stent occlusion, patient death, or at 12-month follow-up. The primary outcome was stent patency. The secondary outcomes included stent occlusion rate, patient survival, mortality, the rate of technical success, and adverse events.

Results

Totally 117 patients were randomized into the three groups. There were no significant differences among the three groups in technical success rate, hospital stay, mortality, patient survival, and adverse events (P = 1.000, 0.553, 0.965, 0.302, and 0.427, respectively). Median stent patency durations in the EEBS-26 cm, EEBS-30 cm, and CPBS groups were 156.0 (95% CI 81.6–230.4) days, 81.0 (95% CI 67.9–94.1) days, and 68.0 (95% CI 20.0–116.0) days, respectively (P = 0.002). The EEBS-26 cm group had longer stent patency compared with the CPBS (P = 0.007) and EEBS-30 cm (P < 0.001) groups. The EEBS-26 cm group had lower stent occlusion rates compared with the other groups at 6 months (48.1% vs. 90.5% vs. 82.8%, P = 0.001) and 9 months (75.0% vs. 100.0% vs. 92.9%, P = 0.022).

Conclusion

EEBS-26 cm has prolonged stent patency and is safe and effective for the alleviation of unresectable extrahepatic malignant biliary obstruction.

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Funding

This study was funded by the National Natural Science Foundation of China (Award Number: 82070653), Beijing Natural Science Foundation (Number: 7222207) and Capital's Funds for Health Improvement and Research (Number: 2022-2Z-40914).

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Authors and Affiliations

  1. The Department of Gastroenterology, Peking University Third Hospital, Haidian District, 49 Huayuan North Road, Beijing, China

    Xiaofen Xu, Yaopeng Zhang, Wei Zheng, Yingchun Wang, Wei Yao, Ke Li, Xiue Yan, Hong Chang & Yonghui Huang

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  1. Xiaofen Xu
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  2. Yaopeng Zhang
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  3. Wei Zheng
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  4. Yingchun Wang
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  7. Xiue Yan
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  8. Hong Chang
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  9. Yonghui Huang
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Contributions

YH designed the EEBSs. XX, XY, HC, and YH conceived and designed the study. XX carried out the initial analysis and prepared the first draft of manuscript. YH, XY, and HC critically reviewed and revised the manuscript. XX, YZ, WZ, and YW completed the work of follow-up. WY and KL conducted the research and collected the data.

Corresponding authors

Correspondence to Xiue Yan, Hong Chang or Yonghui Huang.

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Disclosures

Xiaofen Xu, Yaopeng Zhang, Wei Zheng, Yingchun Wang, Wei Yao, Ke Li, Xiue Yan, Hong Chang, Yonghui Huang have no conflicts of interest or financial ties to disclose.

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Xu, X., Zhang, Y., Zheng, W. et al. Enteral extended biliary stents versus conventional plastic biliary stents for the treatment of extrahepatic malignant biliary obstruction: a single-center prospective randomized controlled study. Surg Endosc 36, 8202–8213 (2022). https://doi.org/10.1007/s00464-022-09265-z

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