Clinical Endoscopy

The Korean Society of Gastrointestinal Endoscopy (대한소화기내시경학회)
권호 표지
DOI QR코드

DOI QR Code

Potential of 6-mm-diameter fully covered self-expandable metal stents for unresectable malignant distal biliary obstruction: a propensity score-matched study

  • Daiki Yamashige (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Susumu Hijioka (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Yoshikuni Nagashio (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Yuta Maruki (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Soma Fukuda (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Shin Yagi (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Kohei Okamoto (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Hidenobu Hara (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Yuya Hagiwara (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Daiki Agarie (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Tetsuro Takasaki (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Akihiro Ohba (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Shunsuke Kondo (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Chigusa Morizane (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Hideki Ueno (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital) ;
  • Miyuki Sone (Department of Diagnostic Radiology, National Cancer Center Hospital) ;
  • Yutaka Saito (Endoscopy Division, National Cancer Center Hospital) ;
  • Takuji Okusaka (Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital)
  • Received : 2024.02.23
  • Accepted : 2024.04.02
  • Published : 2025.01.30
Download PDF
⟨ Previous Next ⟩

Abstract

Background/Aims: To date, only thinner-diameter metal stents have been evaluated for unresectable malignant distal biliary obstruction (UR-MDBO). This study investigated the outcomes and optimal cohorts for a 6-mm-diameter fully covered self-expandable metal stent (FCSEMS) compared with those for a 10-mm-diameter FCSEMS. Methods: This single-center retrospective cohort study included patients who underwent initial transpapillary metal stenting for UR-MDBO. Propensity score matching (1:1) analysis was performed. Results: Of 133/68 patients who underwent 6-mm/10-mm-diameter FCSEMS deployment, 59 in each group were selected. The median time to recurrent biliary obstruction was not significantly different between the groups (p=0.46). In contrast, use of the 6-mm-diameter FCSEMS resulted in a significantly reduced incidence of stent-related adverse events (AEs) (p=0.016), especially cholecystitis (p=0.032), and patients aged <70 years were particularly affected by this significant reduction. Among the patients in the end-stage cohort who were unable to continue chemotherapy after FCSEMS deployment, the free rate of stent-related events, including recurrent biliary obstruction and stent-related AEs, was significantly higher in the 6-mm group (p=0.027). Conclusions: For UR-MDBO, a 6-mm-diameter FCSEMS can be an optimal and safe option in the younger cohort with a relatively high risk of AEs and in the end-stage cohort requiring safer drainage without interference from stent-related events during times of poor prognosis.

Keywords

Acknowledgement

We would like to thank the members of the Endoscopy Team of the Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, for their support of this research.

References

  1. Davids PH, Groen AK, Rauws EA, et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992;340:1488–1492. https://doi.org/10.1016/0140-6736(92)92752-2
  2. Isayama H, Komatsu Y, Tsujino T, et al. A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant biliary obstruction. Gut 2004;53:729– 734. https://doi.org/10.1136/gut.2003.018945
  3. Isayama H, Mukai T, Itoi T, et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointest Endosc 2012;76:84–92. https://doi.org/10.1016/j.gie.2012.02.039
  4. Knyrim K, Wagner HJ, Pausch J, et al. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct. Endoscopy 1993;25:207–212. https://doi.org/10.1055/s-2007-1010294
  5. Kaassis M, Boyer J, Dumas R, et al. Plastic or metal stents for malignant stricture of the common bile duct?: results of a randomized prospective study. Gastrointest Endosc 2003;57:178–182. https://doi.org/10.1067/mge.2003.66
  6. Yeoh KG, Zimmerman MJ, Cunningham JT, et al. Comparative costs of metal versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis. Gastrointest Endosc 1999;49(4 Pt 1):466–471. https://doi.org/10.1016/S0016-5107(99)70044-1
  7. Satoh T, Ishiwatari H, Kawaguchi S, et al. Comparing the 14-mm uncovered and 10-mm covered metal stents in patients with distal biliary obstruction caused by unresectable pancreatic cancer: a multicenter retrospective study. Surg Endosc 2022;36:736–744. https://doi.org/10.1007/s00464-021-08342-z
  8. Mukai T, Yasuda I, Isayama H, et al. Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies. Dig Endosc 2016;28:671–679. https://doi.org/10.1111/den.12643
  9. Kikuyama M, Shirane N, Kawaguchi S, et al. New 14-mm diameter Niti-S biliary uncovered metal stent for unresectable distal biliary malignant obstruction. World J Gastrointest Endosc 2018;10:16–22. https://doi.org/10.4253/wjge.v10.i1.16
  10. Nakaoka K, Hashimoto S, Kawabe N, et al. Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction. Endosc Int Open 2018;6:E1164–E1170. https://doi.org/10.1055/a-0627-7078
  11. Chikugo K, Hayashi T, Tanaka K, et al. Re-intervention with 10- mm vs 12-mm covered self-expandable metallic stent for recurrent unresectable distal biliary obstructio implantation. J Hepatobiliary Pancreat Sci 2023;30:542-549. https://doi.org/10.1002/jhbp.1243
  12. Takeda T, Sasaki T, Mie T, et al. Novel risk factors for recurrent biliary obstruction and pancreatitis after metallic stent placement in pancreatic cancer. Endosc Int Open 2020;8:E1603–E1610. https://doi.org/10.1055/a-1244-1989
  13. Nakai Y, Isayama H, Kawakubo K, et al. Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction. J Gastroenterol Hepatol 2014;29:1557–1562. https://doi.org/10.1111/jgh.12582
  14. Kawakubo K, Isayama H, Nakai Y, et al. Risk factors for pancreatitis following transpapillary self-expandable metal stent placement. Surg Endosc 2012;26:771–776. https://doi.org/10.1007/s00464-011-1950-4
  15. Toyonaga H, Hayashi T, Yamazaki H, et al. Efficacy of pancreatic duct stenting to prevent postendoscopic retrograde cholangiopancreatography pancreatitis after covered self-expandable metal stent deployment. Dig Endosc 2023;35:369–376. https://doi.org/10.1111/den.14442
  16. Suk KT, Kim HS, Kim JW, et al. Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction. Gastrointest Endosc 2006;64:522–529. https://doi.org/10.1016/j.gie.2006.06.022
  17. Kawashima H, Hashimoto S, Ohno E, et al. Comparison of 8- and 10-mm diameter fully covered self-expandable metal stents: a multicenter prospective study in patients with distal malignant biliary obstruction. Dig Endosc 2019;31:439–447. https://doi.org/10.1111/den.13366
  18. Kitano M, Yamashita Y, Tanaka K, et al. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol 2013;108:1713–1722. https://doi.org/10.1038/ajg.2013.305
  19. Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc 2006;63:986–995. https://doi.org/10.1016/j.gie.2005.11.052
  20. Jang S, Stevens T, Parsi MA, et al. Superiority of self-expandable metallic stents over plastic stents in treatment of malignant distal biliary strictures. Clin Gastroenterol Hepatol 2022;20:e182–e195. https://doi.org/10.1016/j.cgh.2020.12.020
  21. Song TJ, Lee JH, Lee SS, et al. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc 2016;84:814–821. https://doi.org/10.1016/j.gie.2016.04.018
  22. Harai S, Hijioka S, Nagashio Y, et al. Comparison of 6-mm and 10-mm-diameter, fully-covered, self-expandable metallic stents for distal malignant biliary obstruction. Endosc Int Open 2023;11:E340–E348. https://doi.org/10.1055/a-2039-4316
  23. Isayama H, Hamada T, Yasuda I, et al. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015;27:259–264. https://doi.org/10.1111/den.12379
  24. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:446–454. https://doi.org/10.1016/j.gie.2009.10.027
  25. Tol JA, van Hooft JE, Timmer R, et al. Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer. Gut 2016;65:1981–1987. https://doi.org/10.1136/gutjnl-2014-308762
  26. van der Gaag NA, Rauws EA, van Eijck CH, et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med 2010;362:129–137. https://doi.org/10.1056/NEJMoa0903230
  27. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383–393. https://doi.org/10.1016/S0016-5107(91)70740-2
  28. Miura F, Takada T, Kawarada Y, et al. Flowcharts for the diagnosis and treatment of acute cholangitis and cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 2007;14:27–34. https://doi.org/10.1007/s00534-006-1153-x
  29. D'Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998;17:2265–2281.
  30. Kataoka F, Inoue D, Watanabe M, et al. Efficacy of 6-mm diameter fully covered self-expandable metallic stents in preoperative biliary drainage for pancreatic ductal adenocarcinoma. DEN Open 2021;2:e55. https://doi.org/10.1002/deo2.55
  31. Loew BJ, Howell DA, Sanders MK, et al. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc 2009;70:445–453. https://doi.org/10.1016/j.gie.2008.11.018
  32. Nakai Y, Isayama H, Kogure H, et al. Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer. J Gastroenterol Hepatol 2014;29:1744–1749. https://doi.org/10.1111/jgh.12602
  33. Coté GA, Kumar N, Ansstas M, et al. Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents. Gastrointest Endosc 2010;72:748–754. https://doi.org/10.1016/j.gie.2010.05.023
  34. Shimizu S, Naitoh I, Nakazawa T, et al. Predictive factors for pancreatitis and cholecystitis in endoscopic covered metal stenting for distal malignant biliary obstruction. J Gastroenterol Hepatol 2013;28:68–72. https://doi.org/10.1111/j.1440-1746.2012.07283.x
  35. Cheng CL, Sherman S, Watkins JL, et al. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol 2006;101:139–147. https://doi.org/10.1111/j.1572-0241.2006.00380.x
  36. Finkelmeier F, Tal A, Ajouaou M, et al. ERCP in elderly patients: increased risk of sedation adverse events but low frequency of post-ERCP pancreatitis. Gastrointest Endosc 2015;82:1051–1059. https://doi.org/10.1016/j.gie.2015.04.032
  37. Old O, Hardy T, Hewin D, et al. Risk of post-ERCP pancreatitis declines with age. Gastrointest Endosc 2016;83:1307–1308. https://doi.org/10.1016/j.gie.2016.01.050