RSS-Feed abonnieren
DOI: 10.1055/s-2001-16214
© Georg Thieme Verlag Stuttgart · New York
Diamond Stents for Palliation of Malignant Bile Duct Obstruction: A Prospective Multicenter Evaluation
Publikationsverlauf
Publikationsdatum:
31. Dezember 2001 (online)
Background and Study Aims: Various types of self-expandable metal stents have been introduced for biliary drainage in patients with malignant jaundice, showing prolonged patency compared with plastic endoprostheses. However, there has only been prolonged experience with a meaningful number of patients using the Wallstent. We evaluated the Diamond stent, a self-expanding uncoated biliary metal stent, in a prospective uncontrolled multicenter setting.
Patients and Methods: The eligibility criterion was obstructive jaundice due to inoperable malignant disease. Between August 1995 and January 2000, 126 patients, who received a total of 134 Diamond stents in four European centers, were followed prospectively.
Results: Technical and clinical success rates were 96 % and 98 %, respectively. No major procedure-related complications occurred. The 30-day mortality rate was 13 %. Stent occlusion occurred in 28 patients (22 %). Overall median stent patency was 477 days; overall median survival was 173 days. Stent occlusion, confirmed by endoscopic retrograde cholangiopancreatography, was successfully treated with plastic stents in all patients. Cost analysis revealed estimated costs of €3440 per patient for palliative treatment with the Diamond stent.
Conclusions: The Diamond stent compares favorably with other biliary metal stents for patients requiring biliary drainage of malignant jaundice.
References
- 1 Speer A G, Cotton P B, Russel R C, et al. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet. 1987; 2 57-62
- 2 Smith A C, Dowsett J F, Russel R C, et al. Randomized trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction. Lancet. 1994; 344 1655-1660
- 3 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
- 4 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
- 5 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
- 6 Carr Locke D L, Ball T J, et al. Multicenter, randomized trial of Wallstent biliary endoprosthesis versus plastic stents. Gastrointest Endosc. 1993; 310 A248
- 7 Prat F, Chapat O, Ducot B, et al. Randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc. 1998; 47 1-7
- 8 Schoefl R, Brownstone E, Reichel W, et al. Malignant bile-duct obstruction: experience with self-expanding metal endoprosthesis (Wallstents) in Austria. Endoscopy. 1994; 26 592-596
- 9 Hoepffner N, Foerster E C, Högemann B, Domschke W. Long-term experience in Wallstent therapy for malignant choledochal stenosis. Endoscopy. 1994; 26 597-602
- 10 O’Brien S, Hatfield A R, Craig P I, Williams S P. A three year follow-up of self expanding metal stents in the endoscopic palliation of longterm survivors with malignant biliary obstruction. Gut. 1995; 36 618-621
- 11 Dumonceau J M, Deviere J. The Ultraflex Diamond stent for malignant biliary obstruction. Gastrointest Endosc Clin N Am. 1999; 9 513-520
- 12 Simon R. Confidence intervals for reporting results of clinical trials. Ann Intern Med. 1986; 105 429-435
- 13 Buckley M J, Letard J C, Rolachon R, Dumas J P. Multicentre trial of a new endobiliary stent (Diamond). Gastroenterology. 1998; 114 A516
- 14 Raijman I, Amin V, Siddique I, et al. The use of the Diamond stent (DS) in the treatment of malignant bile duct stricture (MBDS). Gastrointest Endosc. 1999; 49 AB235
- 15 Seecoomar L F, Cohen S A, Kasmin F E, Siegel J H. Preliminary experience with the Ultraflex Diamond stent for the management of malignant biliary obstruction. Gastrointest Endosc. 1999; 49 AB236
- 16 Siqueria E, Martin J A, Vargas H, et al. Prospective evaluation of a new metal stent for treating malignant biliary obstruction. Gastrointest Endosc. 1999; 49 AB236
- 17 Dumonceau J M, Cremer M, Auroux J, et al. A comparison of Ultraflex Diamond stents and Wallstents for palliation of distal malignant biliary strictures. Am J Gastroenterol. 2000; 95 670-676
- 18 Huibregtse K, Carr-Locke D L, Cremer M, et al. Biliary stent occlusion - a problem solved with self-expanding metal stents? European Wallstent Study Group. Endoscopy. 1992; 24 391-394
- 19 Binmoeller K F, Seitz U, Seifert H, et al. The Tannenbaum stent: a new plastic biliary stent without side holes. Am J Gastroenterol. 1995; 90 1764-1768
- 20 Terruzzi V, Comin U, De Grazia F, et al. Prospective randomized trial comparing Tannenbaum Teflon and standard polyethylene stents in distal malignant biliary stenosis. Gastrointest Endosc. 2000; 51 23-27
- 21 Smits M E, Rauws E HJ, Groen A K. Preliminary results of a prospective randomized study of partially covered wallstents versus non covered wallstents. Gastrointest Endosc. 1995; 41 416
- 22 Isayama H, Komatsu Y, Tsujino T, et al. A prospective randomised study of “covered” vs. “uncovered” metallic stents for distal malignant biliary obstruction. Gastrointest Endosc. 2000; 51 AB191
- 23 Kim H D, Kim J H, Yoo B M, et al. Preliminary results of new covered biliary nitinol stent in patients with malignant obstruction of extrahepatic bile duct (EHD). Gastrointest Endosc. 2000; 51 AB191
A. Ferlitsch,M.D.
Department of Internal Medicine IV
Division of Gastroenterology and Hepatology
University of Vienna
Waehringer Guertel 18 - 20
1090 Vienna
Austria
Fax: + 43-1-404004735
eMail: arnulf.ferlitsch@akh-wien.ac.at