Skip to main content

Advertisement

SpringerLink
Log in

One- and two-step self-expandable metal stent placement for distal malignant biliary obstruction: a propensity analysis

  • Original Article—Liver, Pancreas, and Biliary Tract
  • Published:
Journal of Gastroenterology Aims and scope Submit manuscript

Abstract

Background

Although self-expandable metal stents (SEMS) are widely used for distal malignant biliary obstruction, one-step SEMS (direct placement without a prior plastic stent) and two-step SEMS (placement at second endoscopic retrograde cholangiopancreatography [ERCP] following plastic stent placement) have not been fully compared.

Methods

In this multicenter retrospective study, patients were included who underwent first-time endoscopic SEMS placement between September 1994 and December 2010. We compared the one-step and two-step strategies using a propensity analysis.

Results

In total, 370 patients were identified and one-step SEMS was performed in 59 patients. After adjustment using propensity scores, the median times to dysfunction were 116 and 219 days, respectively, for one-step and two-step SEMS (P = 0.058). Stent migration was more frequently observed in one-step SEMS as compared with two-step SEMS (25 vs. 11 %, P = 0.031). In one-step SEMS, the number of days of hospitalization associated with first-time SEMS placement was shorter compared with that in two-step SEMS (21 vs. 30 days, P = 0.001), and the total costs of SEMS-related interventions within 6 months were lower (6510 and 8100 USD, P = 0.004). The pathological diagnosis rates for pancreatic and biliary tract cancer at initial ERCP were 52 and 61 %. After failed diagnosis at initial ERCP, pathological diagnosis rates for pancreatic cancer were 32 versus 76 % (P = 0.005) by repeated ERCP versus endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA).

Conclusions

One-step SEMS was associated with increased stent migration, despite having potential cost-effectiveness. The additional yield of pathological diagnosis at repeated ERCP was low compared with that yielded by EUS-guided FNA.

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

Similar content being viewed by others

References

  1. Davids P, Groen A, Rauws E, Tytgat G, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992;340:1488–92.

    Article  PubMed  CAS  Google Scholar 

  2. Knyrim K, Wagner H, Pausch J, Vakil N. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct. Endoscopy. 1993;25:207–12.

    Article  PubMed  CAS  Google Scholar 

  3. Lammer J, Hausegger K, Flückiger F, Winkelbauer F, Wildling R, Klein G, et al. Common bile duct obstruction due to malignancy: treatment with plastic versus metal stents. Radiology. 1996;201:167–72.

    PubMed  CAS  Google Scholar 

  4. Isayama H, Yasuda I, Ryozawa S, Maguchi H, Igarashi Y, Matsuyama Y, et al. Results of a Japanese multicenter, randomized trial of endoscopic stenting for non-resectable pancreatic head cancer (JM-test): covered Wallstent versus doublelayer stent. Dig Endosc. 2011;23:310–5.

    Article  PubMed  Google Scholar 

  5. Erickson RA, Garza AA. EUS with EUS-guided fine-needle aspiration as the first endoscopic test for the evaluation of obstructive jaundice. Gastrointest Endosc. 2001;53:475–84.

    Article  PubMed  CAS  Google Scholar 

  6. Gress F, Gottlieb K, Sherman S, Lehman G. Endoscopic ultrasonography-guided fine-needle aspiration biopsy of suspected pancreatic cancer. Ann Intern Med. 2001;134:459–64.

    PubMed  CAS  Google Scholar 

  7. Eloubeidi MA, Chen VK, Eltoum IA, Jhala D, Chhieng DC, Jhala N, et al. Endoscopic ultrasound-guided fine needle aspiration biopsy of patients with suspected pancreatic cancer: diagnostic accuracy and acute and 30-day complications. Am J Gastroenterol. 2003;98:2663–8.

    PubMed  Google Scholar 

  8. Mansfield SD, Scott J, Oppong K, Richardson DL, Sen G, Jaques BC, et al. Comparison of multislice computed tomography and endoscopic ultrasonography with operative and histological findings in suspected pancreatic and periampullary malignancy. Br J Surg. 2008;95:1512–20.

    Article  PubMed  CAS  Google Scholar 

  9. Dewitt J, Devereaux BM, Lehman GA, Sherman S, Imperiale TF. Comparison of endoscopic ultrasound and computed tomography for the preoperative evaluation of pancreatic cancer: a systematic review. Clin Gastroenterol Hepatol. 2006;4:717–25 (quiz 664).

    Google Scholar 

  10. Park HS, Lee JM, Choi HK, Hong SH, Han JK, Choi BI. Preoperative evaluation of pancreatic cancer: comparison of gadolinium-enhanced dynamic MRI with MR cholangiopancreatography versus MDCT. J Magn Reson Imaging. 2009;30:586–95.

    Article  PubMed  Google Scholar 

  11. Enya M, Yasuda I, Mukai T, Shinoda T, Otsuji K, Iwasa J, et al. Endoscopic treatment for benign biliary strictures: can placement of a covered metallic stent be an option in refractory cases? Dig Endosc. 2004;16:12–20.

    Article  Google Scholar 

  12. Kahaleh M, Tokar J, Le T, Yeaton P. Removal of self-expandable metallic Wallstents. Gastrointest Endosc. 2004;60:640–4.

    Article  PubMed  Google Scholar 

  13. Familiari P, Bulajic M, Mutignani M, Lee LS, Spera G, Spada C, et al. Endoscopic removal of malfunctioning biliary self-expandable metallic stents. Gastrointest Endosc. 2005;62:903–10.

    Article  PubMed  Google Scholar 

  14. Park do H, Kim MH, Moon SH, Lee SS, Seo DW, Lee SK. Feasibility and safety of placement of a newly designed, fully covered self-expandable metal stent for refractory benign pancreatic ductal strictures: a pilot study (with video). Gastrointest Endosc. 2008;68:1182–9.

    Google Scholar 

  15. Baron TH, Poterucha JJ. Insertion and removal of covered expandable metal stents for closure of complex biliary leaks. Clin Gastroenterol Hepatol. 2006;4:381–6.

    Article  PubMed  Google Scholar 

  16. Kahaleh M, Brock A, Conaway MR, Shami VM, Dumonceau JM, Northup PG, et al. Covered self-expandable metal stents in pancreatic malignancy regardless of resectability: a new concept validated by a decision analysis. Endoscopy. 2007;39:319–24.

    Article  PubMed  CAS  Google Scholar 

  17. Schmassmann A, von Gunten E, Knuchel J, Scheurer U, Fehr H, Halter F. Wallstents versus plastic stents in malignant biliary obstruction: effects of stent patency of the first and second stent on patient compliance and survival. Am J Gastroenterol. 1996;91:654–9.

    PubMed  CAS  Google Scholar 

  18. Menon K, Romagnuolo J, Barkun A. Expandable metal biliary stenting in patients with recurrent premature polyethylene stent occlusion. Am J Gastroenterol. 2001;96:1435–40.

    Article  PubMed  CAS  Google Scholar 

  19. Artifon EL, Sakai P, Ishioka S, Marques SB, Lino AS, Cunha JE, et al. Endoscopic sphincterotomy before deployment of covered metal stent is associated with greater complication rate: a prospective randomized control trial. J Clin Gastroenterol. 2008;42:815–9.

    Article  PubMed  Google Scholar 

  20. Joffe MM, Rosenbaum PR. Invited commentary: propensity scores. Am J Epidemiol. 1999;150:327–33.

    Article  PubMed  CAS  Google Scholar 

  21. 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;17:2265–81.

    Article  PubMed  Google Scholar 

  22. Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, et al. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010;72:907–14.

    Article  PubMed  Google Scholar 

  23. Kullman E, Frozanpor F, Söderlund C, Linder S, Sandström P, Lindhoff-Larsson A, et al. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010;72:915–23.

    Article  PubMed  Google Scholar 

  24. Isayama H, Komatsu Y, Tsujino T, Yoshida H, Tada M, Shiratori Y, et al. Polyurethane-covered metal stent for management of distal malignant biliary obstruction. Gastrointest Endosc. 2002;55:366–70.

    Article  PubMed  Google Scholar 

  25. Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut. 2004;53:729–34.

    Article  PubMed  CAS  Google Scholar 

  26. Nakai Y, Isayama H, Komatsu Y, Tsujino T, Toda N, Sasahira N, et al. Efficacy and safety of the covered Wallstent in patients with distal malignant biliary obstruction. Gastrointest Endosc. 2005;62:742–8.

    Article  PubMed  Google Scholar 

  27. Saleem A, Leggett CL, Murad MH, Baron TH. 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. 2011.

  28. Coene P, Groen A, Cheng J, Out M, Tytgat G, Huibregtse K. Clogging of biliary endoprostheses: a new perspective. Gut. 1990;31:913–7.

    Article  PubMed  CAS  Google Scholar 

  29. Weickert U, Venzke T, König J, Janssen J, Remberger K, Greiner L. Why do bilioduodenal plastic stents become occluded? A clinical and pathological investigation on 100 consecutive patients. Endoscopy. 2001;33:786–90.

    Article  PubMed  CAS  Google Scholar 

  30. Leung J, Liu Y, Chan R, Tang Y, Mina Y, Cheng A, et al. Early attachment of anaerobic bacteria may play an important role in biliary stent blockage. Gastrointest Endosc. 2000;52:725–9.

    Article  PubMed  CAS  Google Scholar 

  31. Foutch P, Kerr D, Harlan J, Kummet T. A prospective, controlled analysis of endoscopic cytotechniques for diagnosis of malignant biliary strictures. Am J Gastroenterol. 1991;86:577–80.

    PubMed  CAS  Google Scholar 

  32. Pugliese V, Conio M, Nicolo G, Saccomanno S, Gatteschi B. Endoscopic retrograde forceps biopsy and brush cytology of biliary strictures: a prospective study. Gastrointest Endosc. 1995;42:520–6.

    Article  PubMed  CAS  Google Scholar 

  33. Schoefl R, Haefner M, Wrba F, Pfeffel F, Stain C, Poetzi R, et al. Forceps biopsy and brush cytology during endoscopic retrograde cholangiopancreatography for the diagnosis of biliary stenoses. Scand J Gastroenterol. 1997;32:363–8.

    Article  PubMed  CAS  Google Scholar 

  34. de Bellis M, Sherman S, Fogel EL, Cramer H, Chappo J, McHenry L Jr, et al. Tissue sampling at ERCP in suspected malignant biliary strictures (part 2). Gastrointest Endosc. 2002;56:720–30.

    Article  PubMed  Google Scholar 

  35. Yagioka H, Hirano K, Isayama H, Tsujino T, Sasahira N, Nagano R, et al. Clinical significance of bile cytology via an endoscopic nasobiliary drainage tube for pathological diagnosis of malignant biliary strictures. J Hepatobiliary Pancreat Sci. 2011;18:211–5.

    Article  PubMed  Google Scholar 

  36. Chang KJ, Nguyen P, Erickson RA, Durbin TE, Katz KD. The clinical utility of endoscopic ultrasound-guided fine-needle aspiration in the diagnosis and staging of pancreatic carcinoma. Gastrointest Endosc. 1997;45:387–93.

    Article  PubMed  CAS  Google Scholar 

  37. Harewood G, Wiersema M. Endosonography-guided fine needle aspiration biopsy in the evaluation of pancreatic masses. Am J Gastroenterol. 2002;97:1386–91.

    Article  PubMed  Google Scholar 

  38. Wakatsuki T, Irisawa A, Bhutani M, Hikichi T, Shibukawa G, Takagi T, et al. Comparative study of diagnostic value of cytologic sampling by endoscopic ultrasonography-guided fine-needle aspiration and that by endoscopic retrograde pancreatography for the management of pancreatic mass without biliary stricture. J Gastroenterol Hepatol. 2005;20:1707–11.

    Article  PubMed  Google Scholar 

  39. Ross WA, Wasan SM, Evans DB, Wolff RA, Trapani LV, Staerkel GA, et al. Combined EUS with FNA and ERCP for the evaluation of patients with obstructive jaundice from presumed pancreatic malignancy. Gastrointest Endosc. 2008;68:461–6.

    Article  PubMed  Google Scholar 

  40. Tarantino I, Barresi L, Di Pisa M, Traina M. Simultaneous endoscopic ultrasound fine needle aspiration and endoscopic retrograde cholangio-pancreatography: evaluation of safety. World J Gastroenterol. 2007;13:3861–3.

    PubMed  Google Scholar 

  41. Ascunce G, Ribeiro A, Rocha-Lima C, Larsen M, Sleeman D, Merchan J, et al. Single-session endoscopic ultrasonography and endoscopic retrograde cholangiopancreatography for evaluation of pancreaticobiliary disorders. Surg Endosc. 2010;24:1447–50.

    Article  PubMed  Google Scholar 

  42. Klapman JB, Logrono R, Dye CE, Waxman I. Clinical impact of on-site cytopathology interpretation on endoscopic ultrasound-guided fine needle aspiration. Am J Gastroenterol. 2003;98:1289–94.

    Article  PubMed  Google Scholar 

  43. Jhala NC, Jhala DN, Chhieng DC, Eloubeidi MA, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration. A cytopathologist’s perspective. Am J Clin Pathol. 2003;120:351–67.

    Article  PubMed  Google Scholar 

  44. Isayama H, Kawabe T, Nakai Y, Ito Y, Togawa O, Kogure H, et al. Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent. Surg Endosc. 2010;24:131–7.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

We gratefully acknowledge the assistance of Dr. Ryou Nakata, Japanese Red Cross Medical Center; Dr. Kazumi Tagawa, Mitsui Memorial Hospital; Dr. Makoto Okamoto and Dr. Tetsurou Katamoto, JR Tokyo General Hospital; and Dr. Tateo Kawase, Kanto Central Hospital.

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

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

    Tsuyoshi Hamada, Yousuke Nakai, Hiroyuki Isayama, Hirofumi Kogure, Kazumichi Kawakubo, Naoki Sasahira, Kenji Hirano, Natsuyo Yamamoto, Takashi Sasaki, Minoru Tada & Kazuhiko Koike

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

    Tsuyoshi Hamada, Takeshi Tsujino & Yukiko Ito

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

    Osamu Togawa

  4. Department of Gastroenterology, Kanto Central Hospital, Tokyo, Japan

    Suguru Mizuno

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

    Nobuo Toda

Authors
  1. Tsuyoshi Hamada
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yousuke Nakai
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Hiroyuki Isayama
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Osamu Togawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Hirofumi Kogure
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Kazumichi Kawakubo
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Takeshi Tsujino
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Naoki Sasahira
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Kenji Hirano
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Natsuyo Yamamoto
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Yukiko Ito
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Takashi Sasaki
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Suguru Mizuno
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Nobuo Toda
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Minoru Tada
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Kazuhiko Koike
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Hiroyuki Isayama.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hamada, T., Nakai, Y., Isayama, H. et al. One- and two-step self-expandable metal stent placement for distal malignant biliary obstruction: a propensity analysis. J Gastroenterol 47, 1248–1256 (2012). https://doi.org/10.1007/s00535-012-0582-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00535-012-0582-3

Keywords

Search

Navigation