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Covered versus uncovered double bare self-expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: a randomized controlled multicenter trial

  • Author Footnotes
    ∗ Drs Se Woo Park, Kyong Joo Lee, and Moon Jae Chung contributed equally to this article.
    Se Woo Park
    Footnotes
    ∗ Drs Se Woo Park, Kyong Joo Lee, and Moon Jae Chung contributed equally to this article.
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea
    Search for articles by this author
  • Author Footnotes
    ∗ Drs Se Woo Park, Kyong Joo Lee, and Moon Jae Chung contributed equally to this article.
    Kyong Joo Lee
    Footnotes
    ∗ Drs Se Woo Park, Kyong Joo Lee, and Moon Jae Chung contributed equally to this article.
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-do, Korea
    Search for articles by this author
  • Author Footnotes
    ∗ Drs Se Woo Park, Kyong Joo Lee, and Moon Jae Chung contributed equally to this article.
    Moon Jae Chung
    Footnotes
    ∗ Drs Se Woo Park, Kyong Joo Lee, and Moon Jae Chung contributed equally to this article.
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Jung Hyun Jo
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Hee Seung Lee
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Jeong Youp Park
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Seung Woo Park
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Si Young Song
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Huapyong Kang
    Affiliations
    Department of Internal Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea
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  • Eui Joo Kim
    Affiliations
    Department of Internal Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea
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  • Yeon Suk Kim
    Affiliations
    Department of Internal Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea
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  • Jae Hee Cho
    Correspondence
    Reprint requests: Jae Hee Cho, MD, PhD, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonjuro, Gangnam-gu, Seoul 06273, Republic of Korea
    Affiliations
    Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Seungmin Bang
    Correspondence
    Seungmin Bang, MD, PhD, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea.
    Affiliations
    Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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  • Author Footnotes
    ∗ Drs Se Woo Park, Kyong Joo Lee, and Moon Jae Chung contributed equally to this article.
Published:September 06, 2022DOI:https://doi.org/10.1016/j.gie.2022.08.041

      Background and Aims

      In a recent randomized controlled trial, a double bare metal stent (DBS) showed better stent patency than single-layer metal stents. However, clear evidence comparing the efficacy of uncovered (UCDBS) and partially covered (PCDBS) DBSs for distal malignant biliary obstruction (MBO) is lacking. Therefore, we compared the clinical outcomes including stent patency of UCDBSs versus PCDBSs.

      Methods

      A multicenter, randomized study was performed in patients with distal MBO. The primary endpoint was stent patency. Secondary endpoints were the proportion of patients with patent stents at 6 months, risk factors for stent dysfunction, overall survival, technical and clinical success rates of stent placement, and other adverse events (AEs).

      Results

      Among 258 included patients, 130 were randomly assigned to the PCDBS group and 128 to the UCDBS group. The mean duration of stent patency of the PCDBS (421.2 days; 95% confidence interval [CI], 346.7-495.7) was longer than that of the UCDBS (377.4 days; 95% CI, 299.7-455.0), although total stent dysfunction and stent dysfunction within 6 months were not different between groups. Multivariate analysis indicated that chemotherapy after stent placement was a significant factor for overall survival (hazard ratio, .570; 95% CI, .408-.796) and had a marginal impact on stent patency (hazard ratio, 1.569; 95% CI, .923-2.667). There were no remarkable differences in AEs, including pancreatitis, cholecystitis, and stent migration, between the 2 groups.

      Conclusions

      The use of PCDBSs compared with UCDBSs in patients with distal MBO has unclear benefits regarding stent patency and overall survival, although PCDBSs have a lower rate of tumor ingrowth. (Clinical trial registration number: NCT 02937246.)

      Graphical abstract

      Abbreviations:

      AE (adverse event), CI (confidence interval), DBS (double bare metal stent), HR (hazard ratio), MBO (malignant biliary obstruction), PCDBS (partially covered double bare metal stent), SEMS (self-expandable metal stent), UCDBS (uncovered double bare metal stent)
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