Skip to main content

Advertisement

Log in

Percutaneous Palliation of Pancreatic Head Cancer: Randomized Comparison of ePTFE/FEP–Covered Versus Uncovered Nitinol Biliary Stents

  • Clinical Investigation
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

The purpose of this study was to compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)–covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Eighty patients were enrolled in a prospective randomized study. Bare nitinol stents were used in half of the patients, and ePTFE/FEP–covered stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 ± 13.11 days for the bare-stent group and 234.0 ± 20.87 days for the covered-stent group (p = 0.007). Primary patency rates at 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 ± 22.5 days for the bare-stent group and 130.3 ± 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 ± 11.8 days for the bare-stent group and 247.0 ± 20 days for the covered-stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/FEP–covered stents have shown to be significantly superior to bare nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer and pose comparable cost and complications. Use of a covered stent does not significantly influence overall survival rate; nevertheless, the covered endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.

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

Access this article

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

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Parkin DM, Bray F, Ferlay J et al (2005) Global cancer statistics, 2002. CA Cancer J Clin 55:74–108

    Article  PubMed  Google Scholar 

  2. Lowenfels AB, Maisonneuve P (2006) Epidemiology and risk factors for pancreatic cancer. Best Pract Res Clin Gastroenterol 20:197–209

    Article  PubMed  Google Scholar 

  3. Bramhall SR, Allum WH, Jones AG et al (1995) Treatment and survival in 13,560 patients with pancreatic cancer, and incidence of the disease, in the West Midlands: an epidemiological study. Br J Surg 82:111–115

    Article  CAS  PubMed  Google Scholar 

  4. Connolly MM, Dawson PJ, Michelassi F et al (1987) Survival in 1001 patients with carcinoma of the pancreas. Ann Surg 206:366–373

    Article  CAS  PubMed  Google Scholar 

  5. Michelassi F, Erroi F, Dawson PJ et al (1989) Experience with 647 consecutive tumors of the duodenum, ampulla, head of the pancreas, and distal common bile duct. Ann Surg 210:544–554

    Article  CAS  PubMed  Google Scholar 

  6. Shepherd HA, Royle G, Ross AP et al (1988) Endoscopic biliary endoprosthesis in the palliation of malignant obstruction of the distal common bile duct: a randomized trial. Br J Surg 75:1166–1168

    Article  CAS  PubMed  Google Scholar 

  7. Smith AC, Dowsett JF, Russell RC et al (1994) Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction. Lancet 344(8938):1655–1660

    Article  CAS  PubMed  Google Scholar 

  8. Bornman PC, Harries-Jones EP, Tobias R et al (1986) Prospective controlled trial of transhepatic biliary endoprosthesis versus bypass surgery for incurable carcinoma of head of pancreas. Lancet 1(8472):69–71

    Article  CAS  PubMed  Google Scholar 

  9. Andersen JR, Sorensen SM, Kruse A et al (1989) Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Gut 30:1132–1135

    Article  CAS  PubMed  Google Scholar 

  10. Artifon EL, Sakai P, Cunha JE et al (2006) Surgery or endoscopy for palliation of biliary obstruction due to metastatic pancreatic cancer. Am J Gastroenterol 101:2031–2037

    Article  PubMed  Google Scholar 

  11. Lammer J, Hausegger KA, Fluckiger F et al (1996) Common bile duct obstruction due to malignancy: treatment with plastic versus metal stents. Radiology 201:167–172

    CAS  PubMed  Google Scholar 

  12. Rossi P, Bezzi M, Salvatori FM et al (1997) Clinical experience with covered Wallstents for biliary malignancies: 23-month follow-up. Cardiovasc Intervent Radiol 20:441–447

    Article  CAS  PubMed  Google Scholar 

  13. Hausegger KA, Thurnher S, Bodendorfer G et al (1998) Treatment of malignant biliary obstruction with polyurethane covered Wallstents. AJR Am J Roentgenol 170:403–408

    CAS  PubMed  Google Scholar 

  14. Miyayama S, Matsui O, Terayama T et al (1997) Covered Gianturco stents for malignant biliary obstruction: Preliminary clinical evaluation. J Vasc Interv Radiol 8:641–648

    Article  CAS  PubMed  Google Scholar 

  15. Han YM, Jin GY, Lee S et al (2003) Flared polyurethane-covered self-expandable nitinol stent for malignant biliary obstruction. J Vasc Interv Radiol 14:1291–1301

    PubMed  Google Scholar 

  16. Kanasaki S, Furukawa A, Kane T et al (2000) Polyurethane-covered nitinol Strecker stents as primary palliative treatment of malignant biliary obstruction. Cardiovasc Intervent Radiol 23:114–120

    Article  CAS  PubMed  Google Scholar 

  17. Isayama H, Komatsu Y, Tsujino T et al (2002) Polyurethane-covered metal stent for management of distal malignant biliary obstruction. Gastrointest Endosc 55:366–370

    Article  PubMed  Google Scholar 

  18. Isayama H, Komatsu Y, Tsujino T et al (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 

  19. Schoder M, Rossi P, Uflacker R et al (2002) Malignant biliary obstruction: treatment with ePTFE/FEP-covered endoprostheses―initial technical and clinical experiences in a multicenter trial. Radiology 225:35–42

    Article  PubMed  Google Scholar 

  20. Bezzi M, Zolovkins A, Cantisani V et al (2002) New ePTFE/FEP-covered stent in the palliative treatment of malignant biliary obstruction. J Vasc Interv Radiol 13:581–589

    Article  PubMed  Google Scholar 

  21. Hatzidakis A, Krokidis M, Kalbakis K et al (2007) ePTFE/FEP-covered metallic stents for palliation of malignant biliary disease: Can tumor ingrowth be prevented? Cardiovasc Intervent Radiol 30:950–958

    Article  PubMed  Google Scholar 

  22. Fanelli F, Orgera G, Bezzi M et al (2008) Management of malignant biliary obstruction: technical and clinical results using an expanded polytetrafluoroethylene fluorinated ethylene propylene (ePTFE/FEP)-covered metallic stent after 6-year experience. Eur Radiol 18:911–919

    Article  PubMed  Google Scholar 

  23. Krokidis M, Fanelli F, Orgera G et al (2010) Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. Cardiovasc Intervent Radiol 33:97–106

    Article  PubMed  Google Scholar 

  24. Engelken FJ, Bettschart V, Rahman MQ et al (2003) Prognostic factors in the palliation of pancreatic cancer. Eur J Surg Oncol 29:368–373

    Article  CAS  PubMed  Google Scholar 

  25. Ueno H, Okada S, Okusaka T et al (2000) Prognostic factors in patients with metastatic pancreatic adenocarcinoma receiving systemic chemotherapy. Oncology 59:296–301

    Article  CAS  PubMed  Google Scholar 

  26. Falconer JS, Fearon KC, Ross JA et al (1995) Acute-phase protein response and survival duration of patients with pancreatic cancer. Cancer 75:2077–2082

    Article  CAS  PubMed  Google Scholar 

  27. Barber MD, Ross JA, Fearon KC (1999) Changes in nutritional, functional, and inflammatory markers in advanced pancreatic cancer. Nutr Cancer 35:106–110

    Article  CAS  PubMed  Google Scholar 

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

  29. Sacks D, McClenny TE, Cardella JF et al (2003) Society of Interventional Radiology clinical practice guidelines. J Vasc Interv Radiol 14:199–202

    Google Scholar 

  30. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457–481

    Article  Google Scholar 

  31. Gold EB (1995) Epidemiology of and risk factors for pancreatic cancer. Surg Clin North Am 75:819–843

    CAS  PubMed  Google Scholar 

  32. Sohn TA, Lillemoe KD, Cameron JL et al (1999) Surgical palliation of unresectable periampullary adenocarcinoma in the 1990s. J Am Coll Surg 188:658–669

    Article  CAS  PubMed  Google Scholar 

  33. Baron TH (2001) Expandable metal stents for the treatment of cancerous obstruction of the gastrointestinal tract. N Engl J Med 344:1681–1687

    Article  CAS  PubMed  Google Scholar 

  34. Kim HO, Hwang SI, Kim H et al (2008) Quality of survival in patients treated for malignant biliary obstruction caused by unresectable pancreatic head cancer: surgical versus non-surgical palliation. Hepatobiliary Pancreat Dis Int 7:643–648

    PubMed  Google Scholar 

  35. Scott EN, Garcea G, Doucas H et al (2009) Surgical bypass vs. endoscopic stenting for pancreatic ductal adenocarcinoma. HPB (Oxford) 11:118–124

    Google Scholar 

  36. Nakamura T, Hirai R, Kitagawa M et al (2002) Treatment of common bile duct obstruction by pancreatic cancer using various stents: single-centre experience. Cardiovasc Interv Radiol 25:373–380

    Article  Google Scholar 

  37. Isayama H, Kawabe T, Nakai Y et al (2010) Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent. Surg Endosc 24:131–137

    Article  PubMed  Google Scholar 

  38. Ho H, Mahajan A, Gosain S et al (2010) Management of complications associated with partially covered biliary metal stents. Dig Dis Sci 55:516–522

    Article  PubMed  Google Scholar 

  39. Rossi P, Bezzi M, Rossi M et al (1994) Metallic stents in malignant biliary obstruction: results of a multicenter European study of 240 patients. J Vasc Interv Radiol 5:279–285

    Article  CAS  PubMed  Google Scholar 

  40. Lee BH, Choe DH, Lee JH et al (1997) Metallic stents in malignant biliary obstruction: prospective long-term clinical results. AJR Am J Roentgenol 168:741–745

    CAS  PubMed  Google Scholar 

  41. Brountzos EN, Ptochis N, Panagiotou I et al (2007) A survival analysis of patients with malignant biliary strictures treated by percutaneous metallic stenting. Cardiovasc Intervent Radiol 30:66–73

    Article  PubMed  Google Scholar 

  42. Katsinelos P, Kountouras J, Paroutoglou G et al (2008) Uncovered Hanaro versus Luminex metal stents for palliation of malignant biliary strictures. J Clin Gastroenterol 42:539–545

    Article  PubMed  Google Scholar 

  43. Boguth L, Tatalovic S, Antonucci F et al (1994) Malignant biliary obstruction: clinical and histopathologic correlation after treatment with self-expanding metal prostheses. Radiology 192:669–674

    CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Miltiadis Krokidis.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Krokidis, M., Fanelli, F., Orgera, G. et al. Percutaneous Palliation of Pancreatic Head Cancer: Randomized Comparison of ePTFE/FEP–Covered Versus Uncovered Nitinol Biliary Stents. Cardiovasc Intervent Radiol 34, 352–361 (2011). https://doi.org/10.1007/s00270-010-9880-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00270-010-9880-4

Keywords

Navigation