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Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent

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Abstract

Background

The covered metallic stent is effective for managing malignant distal biliary obstructions. The most popular covered metallic stent is the covered Wallstent (CWS). This study estimated the efficacy and safety of a new expanded polytetrafluoroethylene (e-PTFE)-covered nitinol metallic stent, the ComVi stent. This covered metallic stent consists of an e-PTFE membrane sandwiched between two uncovered metallic stents with weak axial (straightening) force. Wire is exposed on both the inner and outer surfaces.

Methods

Between May 2005 and April 2007, ComVi stents were placed consecutively in 47 patients with unresectable malignant distal biliary obstruction. The cases involved 35 pancreatic cancers, 8 metastatic nodes, 2 gallbladder cancers, and 2 bile duct cancers. The patients were compared with 47 patients who received CWS placement between August 2001 and May 2005 matched for age, sex, and causative disease from 133 cases.

Results

No significant differences in stent patency or patient survival were found. Stent occlusion was observed in 13 patients (27.7%) in the ComVi group and 10 patients (21.3%) in the CWS group. The cause of occlusion in both groups was tumor overgrowth (4.25% vs 4.2%), sludge (8.5% vs 6.3%), impaction of food scraps (14.9% vs 2.1%), and bile duct kinking (0% vs 8.4%). Other complications were migration (2.1% vs 17.0%; p = 0.0304) and cholecystitis (2.1% vs 6.3%), and there were significant differences in the incidence of complications except for occlusion (4.2% vs 24.6%; p = 0.0142).

Conclusion

The ComVi stent has a patency similar to that of the CWS and a lower incidence of migration. However, early occlusion by food impaction was increased and should be resolved.

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References

  1. Davids PHP, Groen AK, Rauws EAJ, Tytgat GNJ, Huibregtse K (1992) Randomized trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 340:1488–1492

    Article  CAS  PubMed  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  3. Saito H, Sakurai Y, Takamura A, Horio K (1994) Biliary endoprosthesis using Gore-Tex–covered expandable metallic stents: preliminary clinical evaluation. Nippon Acta Radiologica 54:180–182

    CAS  PubMed  Google Scholar 

  4. Shim CS, Lee YH, Cho YD, Bong HK, Kim JO, Cho JY, Kim YS, Lee JS, Lee MS, Hwang SG, Shin KM (1998) Preliminary results of a new covered biliary metal stent for malignant biliary obstruction. Endoscopy 30:345–350

    Article  CAS  PubMed  Google Scholar 

  5. Isayama H, Komatsu Y, Tsujino T, Yoshida H, Tada M, Shiratori Y, Kawabe T, Omata M (2002) Polyurethane-covered metal stent for management of distal malignant biliary obstruction. Gastrointest Endosc 55:366–370

    Article  PubMed  Google Scholar 

  6. 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 randomized study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 53:729–734

    Article  CAS  PubMed  Google Scholar 

  7. Kubota Y, Mukai H, Nakaizumi A, Tanaka K, Okabe Y, Sakagami T, Kitano M, Mitsufuji S, Shirasaka D, Kikuchi E, Koyama S, Shujiro Y, Shiba M, Yasuda K (2005) Covered Wallstent for palliation of malignant common bile duct stricture: prospective multicenter evaluation. Dig Endosc 17:218–223

    Article  Google Scholar 

  8. Kahaleh M, Tokar J, Conaway MR, Brock A, Le T, Adams RB, Yeaton P (2005) Efficacy and complications of covered Wallstents in malignant distal biliary obstruction. Gastrointest Endosc 61:528–533

    Article  PubMed  Google Scholar 

  9. Nakai Y, Isayama H, Komatsu Y, Tsujino T, Toda N, Sasahira N, Yamamoto N, Hirano K, Tada M, Yoshida H, Kawabe T, Omata M (2005) Efficacy and safety of covered Wallstent in patients with distal malignant biliary obstruction. Gastrointest Endosc 62:742–748

    Article  PubMed  Google Scholar 

  10. Isayama H, Kawabe T, Nakai Y, Tsujino T, Sasahira N, Yamamoto N, Arizumi T, Togawa O, Matsubara S, Ito Y, Sasaki T, Hirano K, Toda N, Komatsu Y, Tada M, Yoshida H, Omata M (2006) Cholecystitis after metallic stent placement in patients with malignant distal biliary obstruction. Clin Gastroenterol Hepatol 4:1148–1153

    Article  PubMed  Google Scholar 

  11. Isayama H, Nakai Y, Toyokawa Y, Togawa O, Chimyon Gon, Ito Y, Yashima Y, Yagioka H, Kogure H, Sasaki T, Arizumi T, Matsubara S, Yamamoto N, Sasahira N, Hirano K, Tsujino T, Toda N, Tada M, Kawabe T, Omata M (2009) Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointest Endosc, in press (available online)

  12. WHO handbook for reporting results of cancer treatment (1979) World Health Organization, Geneva

  13. Suk KT, Kim HS, Kim JW, Baik SK, Kwon SO, Kim HG, Lee DH, Yoo BM, Kim JH, Moon YS, Lee DK (2006) Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction. Gastrointest Endosc 64:522–529

    Article  PubMed  Google Scholar 

  14. Nakai Y, Isayama H, Tsujino T, Kawabe T, Yashima Y, Yagioka H, Kogure H, Sasaki T, Togawa O, Arizumi T, Ito Y, Matsubara S, Hirano K, Sasahira N, Tada M, Omata M (2008) Intraductal US in the assessment of tumor involvement to the orifice of the cystic duct by malignant biliary obstruction. Gastrointest Endosc 68:78–83

    Article  PubMed  Google Scholar 

  15. StatView for Windows, Version 5.0 (1999) Stat Methods Med Res 8:337–341

    Google Scholar 

  16. Shin HP, Kim MH, Jung SW, Kim JC, Choi EK, Han J, Lee SS, Seo DW, Lee SK (2006) Endoscopic removal of biliary self-expandable metallic stents: a prospective study. Endoscopy 38:1250–1255

    Article  CAS  PubMed  Google Scholar 

  17. Kahaleh M, Tokar J, Le T, Yeaton P (2004) Removal of self-expandable metallic Wallstents. Gastrointest Endosc 60:640–644

    Article  PubMed  Google Scholar 

  18. Wasan SM, Ross WA, Staekel GA, Lee JH (2005) Use of expandable metallic stent in resectable pancreatic cancer. Am J Gastroenterol 100:2056–2061

    Article  PubMed  Google Scholar 

  19. Sauer B, Talreja J, Ellen K, Ku J, Shami VM, Kahaleh M (2008) Temporary placement of a fully covered self-expandable metal stent in the pancreatic duct for management of symptomatic refractory chronic pancreatitis: preliminary data (with videos). Gastrointest Endosc 68:1173–1178

    Article  PubMed  Google Scholar 

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Acknowledgments

We gratefully acknowledge the assistance of Drs. Ryou Nakata and Yoshikazu Maruyama of the Japanese Red Cross Medical Center, Drs. Kazumi Tagawa and Makoto Taniguchi of Mitsui Memorial Hospital, and Dr. Tetsurou Katamoto of Tokyo General Hospital.

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Authors and Affiliations

  1. Department of Gastroenterology, Faculty of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Hiroyuki Isayama, Yousuke Nakai, Osamu Togawa, Hirofumi Kogure, Yoko Yashima, Saburo Matsubara, Naoki Sasahira, Kenji Hirano, Takeshi Tsujino, Minoru Tada & Masao Omata

  2. Department of Endoscopy and Endoscopic Surgery, Faculty of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Takao Kawabe

  3. Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan

    Yukiko Ito

  4. Department of Gastroenterology, JR Tokyo General Hospital, Tokyo, Japan

    Hiroshi Yagioka

  5. Department of Gastroenterology, Mitsui Memorial Hospital, Tokyo, Japan

    Takashi Sasaki

Authors
  1. Hiroyuki Isayama
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  2. Takao Kawabe
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  3. Yousuke Nakai
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  4. Yukiko Ito
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  5. Osamu Togawa
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  6. Hirofumi Kogure
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  7. Yoko Yashima
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  8. Hiroshi Yagioka
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  9. Saburo Matsubara
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  10. Takashi Sasaki
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  11. Naoki Sasahira
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  12. Kenji Hirano
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  13. Takeshi Tsujino
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  14. Minoru Tada
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  15. Masao Omata
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Corresponding author

Correspondence to Hiroyuki Isayama.

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Isayama, H., Kawabe, T., Nakai, Y. et al. Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent. Surg Endosc 24, 131–137 (2010). https://doi.org/10.1007/s00464-009-0537-9

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  • DOI: https://doi.org/10.1007/s00464-009-0537-9

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