Skip to main content
SpringerLink
Log in

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction

  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

Abstract

Background and aims

A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth.

Patients and methods

We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.).

Results

The mean age was 66.6 years (range, 35–83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration.

Conclusions

The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Abraham NS, Barkun JS, Barkun AN (2002) Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life. Gastrointest Endosc 56(6):835–841

    Article  PubMed  Google Scholar 

  2. Rustagi T, Jamidar PA (2015) Endoscopic treatment of malignant biliary strictures. Curr Gastroenterol Rep 17(1):1–8

    Article  Google Scholar 

  3. Sawas T, Al Halabi S, Parsi MA, Vargo JJ (2015) Self-expandable metal stents versus plastic stents for malignant biliary obstruction: a meta-analysis. Gastrointest Endosc 82(2):256–267

    Article  PubMed  Google Scholar 

  4. Davids PH, Groen AK, Rauws E, Tytgat GN, Huibregtse K (1992) Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 340(8834):1488–1492

    Article  CAS  PubMed  Google Scholar 

  5. Almadi MA, Barkun AN, Martel M (2013) No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol 11(1):27–37

    Article  PubMed  Google Scholar 

  6. Saleem A, Leggett CL, Murad MH, Baron TH (2011) Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation of distal malignant bile duct obstruction. Gastrointest Endosc 74(2):321–327

    Article  PubMed  Google Scholar 

  7. Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC (2010) A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc 72(5):907–914

    Article  PubMed  Google Scholar 

  8. Knyrim K, Wagner H, Pausch J, Vakil N (1993) A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct. Endoscopy 25(3):207–212

    Article  CAS  PubMed  Google Scholar 

  9. Soderlund C, Linder S (2006) Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc 63(7):986–995

    Article  PubMed  Google Scholar 

  10. Yoon WJ, Ryu JK, Yang KY, Paik WH, Lee JK, Woo SM, Park JK, Kim Y-T, Yoon YB (2009) A comparison of metal and plastic stents for the relief of jaundice in unresectable malignant biliary obstruction in Korea: an emphasis on cost-effectiveness in a country with a low ERCP cost. Gastrointest Endosc 70(2):284–289

    Article  PubMed  Google Scholar 

  11. Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, Nishiyama O, Uehara H, Mitoro A, Sanuki T, Takaoka M, Koshitani T, Arisaka Y, Shiba M, Hoki N, Sato H, Sasaki Y, Sato M, Hasegawa K, Kawabata H, Okabe Y, Mukai H (2013) 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 108(11):1713–1722

    Article  PubMed  Google Scholar 

  12. Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A (2010) Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. Cardiovasc Interv Radiol 33(1):97–106

    Article  Google Scholar 

  13. Krokidis M, Fanelli F, Orgera G, Tsetis D, Mouzas I, Bezzi M, Kouroumalis E, Pasariello R, Hatzidakis A (2011) Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. Cardiovasc Interv Radiol 34(2):352–361

    Article  Google Scholar 

  14. Lee S, Cha SW, Cheon YK, Kim Y, Moon J, Cho Y, Kim Y, Lee J, Lee M, Shim CS (2004) A randomized controlled comparative study of covered versus uncovered self-expandable metal stent for malignant biliary obstruction. Gastrointest Endosc 59(5):P188

    Article  Google Scholar 

  15. Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, Nakai Y, Yamamoto N, Tada M, Yoshida H, Shiratori Y, Kawabe T, Omata M (2004) A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 53(5):729–734

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH (2009) 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 70(3):445–453

    Article  PubMed  Google Scholar 

  17. Lee JH, Krishna SG, Singh A, Ladha HS, Slack RS, Ramireddy S, Raju GS, Davila M, Ross WA (2013) Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients. Gastrointest Endosc 78(2):312–324

    Article  PubMed  Google Scholar 

  18. Katsinelos P, Kountouras J, Paroutoglou G, Paikos D, Moschos J, Chatzimavroudis G, Zavos C, Makrigiannis E (2008) Uncovered Hanaro Versus Luminex metal stents for palliation of malignant biliary strictures. J Clin Gastroenterol 42(5):539–545

    Article  PubMed  Google Scholar 

  19. Fumex F, Coumaros D, Napoleon B, Barthet M, Laugier R, Yzet T, Le Sidaner A, Desurmont P, Lamouliatte H, Letard J (2006) Similar performance but higher cholecystitis rate with covered biliary stents: results from a prospective multicenter evaluation. Endoscopy 38(8):787–792

    Article  CAS  PubMed  Google Scholar 

  20. Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gozen M, Eriksson O (2010) Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc 72(5):915–923

    Article  PubMed  Google Scholar 

  21. Kawakubo K, Isayama H, Nakai Y, Togawa O, Sasahira N, Kogure H, Sasaki T, Matsubara S, Yamamoto N, Hirano K (2011) Efficacy and safety of covered self-expandable metal stents for management of distal malignant biliary obstruction due to lymph node metastases. Surg Endosc 25(9):3094–3100

    Article  PubMed  Google Scholar 

  22. Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK (2015) Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 81(1):143–149

    Article  PubMed  Google Scholar 

  23. Park SW, Chung MJ, Oh TG, Park JY, Bang S, Park SW, Song SY (2015) Intramuscular diclofenac for the prevention of post-ERCP pancreatitis: a randomized trial. Endoscopy 47(1):33–39

    PubMed  Google Scholar 

  24. Park SB, Kim HW, Kang DH, Choi CW, Ryu JH, Chu CW, Lee SY, Jeong YI, Yeo HJ, Kim EJ (2012) Metallic or plastic stent for bile duct obstruction in ampullary cancer? Dig Dis Sci 57(3):786–790

    Article  CAS  PubMed  Google Scholar 

Download references

Author contributions

MJC, CMN, SB, and SWP contributed to conception and design of the study. MJC and HJL helped with generation, collection, assembly, analysis, and/or interpretation of data. HJL, MJC, and SB helped in drafting and/or revision of the manuscript. JYP, SB, SWP, and SYS helped with critical revision of the article for important intellectual content. SB contributed to approval of the final version of the manuscript.

Disclosures

Drs. HJL, MJC, JYP, SWP, CMN, SYS, and SB have no conflicts of interest or financial ties to disclose.

Author information

Author notes

    Authors and Affiliations

    1. Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea

      Hyun Jik Lee, Moon Jae Chung, Jeong Yup Park, Seung Woo Park, Si Young Song & Seungmin Bang

    2. Department of Biostatistics, Yonsei University College of Medicine, Seoul, Korea

      Chung Mo Nam

    Authors
    1. Hyun Jik Lee
      View author publications

      You can also search for this author in PubMed Google Scholar

    2. Moon Jae Chung
      View author publications

      You can also search for this author in PubMed Google Scholar

    3. Jeong Yup Park
      View author publications

      You can also search for this author in PubMed Google Scholar

    4. Seung Woo Park
      View author publications

      You can also search for this author in PubMed Google Scholar

    5. Chung Mo Nam
      View author publications

      You can also search for this author in PubMed Google Scholar

    6. Si Young Song
      View author publications

      You can also search for this author in PubMed Google Scholar

    7. Seungmin Bang
      View author publications

      You can also search for this author in PubMed Google Scholar

    Corresponding author

    Correspondence to Seungmin Bang.

    Additional information

    Hyun Jik Lee and Moon Jae Chung are contributed equally to this work.

    Rights and permissions

    Reprints and permissions

    About this article

    Check for updates. Verify currency and authenticity via CrossMark

    Cite this article

    Lee, H.J., Chung, M.J., Park, J.Y. et al. A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction. Surg Endosc 31, 3159–3167 (2017). https://doi.org/10.1007/s00464-016-5341-8

    Download citation

    • Received:

    • Accepted:

    • Published:

    • Issue Date:

    • DOI: https://doi.org/10.1007/s00464-016-5341-8

    Keywords

    Search

    Navigation