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Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: A multicenter randomized trial

Published:March 10, 2023DOI:https://doi.org/10.1016/j.gie.2023.03.007
Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: A multicenter randomized trial
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      ABSTRACT

      Background and aims

      The efficacy of the suprapapillary placement of inside plastic stents (iPSs) for unresectable malignant hilar biliary obstructions (MHOs) has been unknown in comparison with that of inside uncovered metal stents (iMSs). This randomized controlled trial was designed to evaluate the outcomes of endoscopic placement of these stents for unresectable MHOs.

      Methods

      This was an open-label, randomized study at 12 Japanese institutions. The enrolled patients with unresectable MHOs were allocated to iPS and iMS groups. The primary outcome was defined as the time to recurrent biliary obstruction (RBO) in patients for whom the intervention was both technically and clinically successful.

      Results

      Among 87 enrollments, 38 in the iPS group and 46 in the iMS group were analyzed. The technical success rates were 100% (38) and 96.6% (44/46), respectively (p = 1.00). After transferring 1 unsuccessful iMS-group patient to the iPS group, since iPSs were deployed, the clinical success rates were 90.0% (35/39) for the iPS group and 88.9% (40/45) for the iMS group from a per-protocol analysis (p = 1.00). Among the patients with clinical successes, the median times to RBO were 250 (95% confidence interval [CI], 85−415) and 361 (107−615) days, respectively (p = 0.34; log-rank test). No differences were detected in rates of adverse events.

      Conclusions

      This phase II randomized trial did not demonstrate any statistically significant difference in stent patency between suprapapillary plastic vs. metal stents. Considering the potential advantages of plastic stents for malignant hilar obstruction, these findings suggest that suprapapillary plastic stents could represent a viable alternative to metal stents for this condition.

      Graphical abstract

      Figure thumbnail fx1
      Graphical Abstract

      Keywords

      Acronyms and abbreviations:

      iPS (inside plastic stent), MHO (malignant hilar biliary obstruction), iMS (inside metal stent), RBO (recurrent biliary obstruction), ASGE (American Society for Gastrointestinal Endoscopy), TB (total biliarubin), IOC (intervention of concern), ERCP (endoscopic retrograde cholangiopancreatography), EST (endoscopic sphincterotomy), SIS (stent-in-stent), SBS (side-by-side), TRBO (time to recurrent biliary obstruction), SD (standard deviations), PTBD (percutaneous transhepatic biliary drainage), EUS-BD (EUS-guided biliary drainage)
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      Article info

      Publication history

      Accepted: March 6, 2023
      Received in revised form: March 6, 2023
      Received: December 9, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Author Contributions

      Yoshihide Kanno, M.D. 1, Conceptualization, data curation, formal analysis, investigation, methodology, visualization, writing – original draft

      Kei Ito, M.D., Ph.D. 1, Supervision, validation

      Kazunari Nakahara, M.D., Ph.D. 3, Investigation

      Shinya Kawaguchi, M.D. 4, Investigation

      Yoshiharu Masaki, M.D. 5, Investigation

      Toru Okuzono, M.D., Ph.D. 2, Investigation, visualization

      Hironari Kato, M.D., Ph.D. 6, Investigation

      Masaki Kuwatani, M.D., Ph.D. 7, Investigation

      Shotaro Ishii, M.D. 8, Investigation

      Toji Murabayashi, M.D. 1,9, Investigation

      Sho Hasegawa, M.D., Ph.D. 1,10, Investigation

      Masatsugu Nagahama, M.D., Ph.D. 11, Investigation

      Yuji Iwashita, M.D., Ph.D. 12, Investigation

      Yosuke Michikawa, M.D., Ph.D. 3, Investigation

      Shuzo Terada, M.D. 4, Investigation

      Yujiro Kawakami, M.D. 1,5, Investigation

      Yuki Fujii, M.D., Ph.D. 1,6, Investigation

      Kazumichi Kawakubo, M.D., Ph.D. 7, Investigation

      Identification

      DOI: https://doi.org/10.1016/j.gie.2023.03.007

      Copyright

      © 2023 by the American Society for Gastrointestinal Endoscopy

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