Covered self-expandable metal stents in pancreatic malignancy regardless of resectability: a new concept validated by a decision analysis

Background and study aims: The current treatment model for the management of malignant biliary obstruction is to place a plastic stent for unstaged pancreatic cancer. In patients with unresectable disease but a life expectancy of more than 6 months, self-expandable metal stents (SEMS) are favored because of their more prolonged patency. We analyzed the efficacy and cost-effectiveness of covered SEMS (CSEMS) in patients with pancreatic cancer and distal biliary obstruction without regard to surgical resectability.

Patients and methods: Between March 2001 and March 2005, 101 consecutive patients with obstructive jaundice secondary to pancreatic cancer underwent placement of a CSEMS. Patients with resectable tumor were offered pancreaticoduodenectomy. A model was developed to compare the costs of CSEMS and polyethylene and DoubleLayer stents.

Results: A total of 21 patients underwent staging laparoscopy, of whom 16 had a resection (76 %). The 85 patients who did not have a resection had a mean survival of 5.9 months (range 1 - 25 months) and a mean CSEMS patency duration of 5.5 months (range 1 - 16 months). Life-table analysis demonstrated CSEMS patency rates of 97 % at 3 months, 85 % at 6 months, and 68 % at 12 months. In a cost model that accounted for polyethylene and DoubleLayer stent malfunction and surgical resections, initial CSEMS placement (€ 3177 per patient) was a less costly intervention than either DoubleLayer stent placement (€ 3224 per patient) or polyethylene stent placement with revision (€ 3570 per patient).

Conclusions: Covered SEMS are an effective treatment for distal biliary obstructions caused by pancreatic carcinoma. Their prolonged patency and removability makes them an attractive option for biliary decompression, regardless of resectability. The strategy of initial covered SEMS placement might be the most cost-effective strategy in these patients.

References

• 1 Warshaw A L, Fernandez-del Castillo C. Pancreatic carcinoma.  N Engl J Med. 1992;  326 455-465
• 2 Shepherd H A, Royle G, Ross A P. et al . Endoscopic biliary endoprosthesis in the palliation of malignant obstruction of the distal common bile duct: a randomized trial.  Br J Surg. 1988;  75 1166-1168
• 3 Smith A C, Dowsett J F, Russell R C. et al . Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction.  Lancet. 1994;  344 1655-1660
• 4 Andersen J R, Sorensen S M, Kruse A. et al . Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice.  Gut. 1989;  30 1132-1135
• 5 Prat F, Chapat O, Ducot B. et al . A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct.  Gastrointest Endosc. 1998;  47 1-7
• 6 Arguedas M R, Heudebert G H, Stinnett A A, Wilcox C M. Biliary stents in malignant obstructive jaundice due to pancreatic carcinoma: a cost-effectiveness analysis.  Am J Gastroenterol. 2002;  97 898-904
• 7 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
• 8 Kahaleh M, Tokar J, Le T, Yeaton P. Removal of self-expandable metallic Wallstents.  Gastrointest Endosc. 2004;  60 640-644
• 9 Familiari P, Bulajic M, Mutignani M. et al . Endoscopic removal of malfunctioning biliary self-expandable metallic stents.  Gastrointest Endosc. 2005;  62 903-910
• 10 Tringali A, Mutignani M, Perri V. et al . A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures.  Endoscopy. 2003;  35 992-997
• 11 Kahaleh M, Tokar J, Conaway M R. et al . Efficacy and complications of covered Wallstents in malignant distal biliary obstruction.  Gastrointest Endosc. 2005;  61 528-533
• 12 Greenlee R T, Hill-Harmon M B, Murray T, Thun M. Cancer statistics, 2001.  CA Cancer J Clin. 2001;  51 15-36
• 13 Barkin J S, Goldstein J A. Diagnostic approach to pancreatic cancer.  Gastroenterol Clin North Am. 1999;  28 709-722, xi
• 14 Luman W, Cull A, Palmer K R. Quality of life in patients stented for malignant biliary obstructions.  Eur J Gastroenterol Hepatol. 1997;  9 481-484
• 15 Ballinger A B, McHugh M, Catnach S M. et al . Symptom relief and quality of life after stenting for malignant bile duct obstruction.  Gut. 1994;  35 467-470
• 16 Abraham N S, Barkun J S, Barkun A N. Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life.  Gastrointest Endosc. 2002;  56 835-841
• 17 Knyrim K, Wagner H J, Pausch J, Vakil N. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct.  Endoscopy. 1993;  25 207-212
• 18 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
• 19 Davids P H, Groen A K, Rauws E A. et al . Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction.  Lancet. 1992;  340 1488-1492
• 20 Levy M J, Baron T H, Gostout C J. et al . Palliation of malignant extrahepatic biliary obstruction with plastic versus expandable metal stents: an evidence-based approach.  Clin Gastroenterol Hepatol. 2004;  2 273-285
• 21 Yeoh K G, Zimmerman M J, Cunningham J T, Cotton P B. Comparative costs of metal versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis.  Gastrointest Endosc. 1999;  49 466-471
• 22 Shim C S, Lee Y H, Cho Y D. et al . Preliminary results of a new covered biliary metal stent for malignant biliary obstruction.  Endoscopy. 1998;  30 345-350
• 23 Thurnher S A, Lammer J, Thurnher M M. et al . Covered self-expanding transhepatic biliary stents: clinical pilot study.  Cardiovasc Intervent Radiol. 1996;  19 10-14
• 24 Rossi P, Bezzi M, Salvatori F M. et al . Clinical experience with covered Wallstents for biliary malignancies: 23-month follow-up.  Cardiovasc Intervent Radiol. 1997;  20 441-447
• 25 Born P, Neuhaus H, Rösch T. et al . Initial experience with a new, partially covered Wallstent for malignant biliary obstruction.  Endoscopy. 1996;  28 699-702
• 26 Hausegger K A, Thurnher S, Bodendorfer G. et al . Treatment of malignant biliary obstruction with polyurethane-covered Wallstents.  AJR Am J Roentgenol. 1998;  170 403-408
• 27 Isayama H, Komatsu Y, Tsujino T. et al . Polyurethane-covered metal stent for management of distal malignant biliary obstruction.  Gastrointest Endosc. 2002;  55 366-370
• 28 Bezzi M, Zolovkins A, Cantisani V. et al . New ePTFE/FEP-covered stent in the palliative treatment of malignant biliary obstruction.  J Vasc Interv Radiol. 2002;  13 581-589
• 29 Nakai Y, Isayama H, Komatsu Y. et al . Efficacy and safety of the covered Wallstent in patients with distal malignant biliary obstruction.  Gastrointest Endosc. 2005;  62 742-774
• 30 Hawes R H. Diagnostic and therapeutic uses of ERCP in pancreatic and biliary tract malignancies.  Gastrointest Endosc. 2002;  56 S201-S205
• 31 Wamsteker E J, Elta G H. Migration of covered biliary self-expanding metallic stents in two patients with malignant biliary obstruction.  Gastrointest Endosc. 2003;  58 792-793
• 32 Matsushita M, Takakuwa H, Nishio A. et al . Open-biopsy-forceps technique for endoscopic removal of distally migrated and impacted biliary metallic stents.  Gastrointest Endosc. 2003;  58 924-927
• 33 Miyayama S, Matsui O, Terayama N. et al . Covered gianturco stents for malignant biliary obstruction: preliminary clinical evaluation.  J Vasc Interv Radiol. 1997;  8 641-648
• 34 Wasan S M, Ross W A, Staerkel G A, Lee J H. Use of expandable metallic biliary stents in resectable pancreatic cancer.  Am J Gastroenterol. 2005;  100 2056-2061
• 35 Mullen J T, Lee J H, Gomez H F. et al . Pancreaticoduodenectomy after placement of endobiliary metal stents.  J Gastrointest Surg. 2005;  9 1094-1105
• 36 Chen V K, Arguedas M R, Baron T H. Expandable metal biliary stents before pancreaticoduodenectomy for pancreatic cancer: a Monte-Carlo decision analysis.  Clin Gastroenterol Hepatol. 2005;  3 1229-1237