Background and Aims. For distal malignant biliary obstruction in cases with short life expectancy, occlusion of plastic stents (PSs) does not usually occur before death, and the application of such a procedure is considered adequate from the viewpoint of cost-effectiveness. Methods and Setting. A new commercially available DLS with side holes, a conventional DLS, and, uncovered self-expanding metal stents (SEMSs) were retrospectively evaluated in patients with jaundice due to unresectable distal malignant biliary obstruction. Results. A total of 64 patients received endoscopic biliary stenting (23 patients with the new DLS, 24 patients with conventional DLS, and 17 patients with uncovered SEMS) from December 2002 to August 2009. Median patency time was found to be 198 days for the new DLS group and 99 days for the conventional DLS group, revealing a significant difference between devices. There was, however, no significant difference in median patency time between the new DLS and the uncovered SEMS (198 days versus 344 days). Conclusion. The new DLS is efficient and safe and may be considered the first choice for unresectable distal malignant obstruction in cases with short life expectancy. 1. Introduction Endoscopic biliary stenting is a well-established method, and endoscopic palliation of malignant jaundice can improve patient quality of life. Two types of biliary stents, each of a different material, are routinely used: plastic stents (PSs) and self-expanding metal stents (SEMSs), and it is necessary for each stent to be appropriately selected for each case. SEMSs have a longer patency period than plastic stents. However, uncovered SEMSs (UMSs) also have several drawbacks, including higher cost, irretrievability once placed, and susceptibility to tumor overgrowth and ingrowth, which may result in stent dysfunction [1]. PSs on the other hand are less expensive and remain a popular alternative to metallic stents. Their major drawback, however, is their propensity to clog, often necessitating repeated stent changes in order to maintain biliary drainage [2]. To prolong the duration of PSs patency, a double-layer stent (DLS; Olympus Medical Systems, Tokyo, Japan) has been developed and shown to be superior to regular PSs with respect to patency and is consequently being used more frequently than PSs [3]. When bending of the malignant bile duct is advanced, the tip of the stent impacts the biliary wall, and since the stent has an orifice only in the tip, this situation leads to an early occlusion of DLS and becomes a major issue [3, 4]. To handle this
References
[1]
P. H. Davids, A. K. Groen, E. A. Rauws, G. N. Tytgat, and K. Huibregtse, “Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction,” The Lancet, vol. 340, no. 8834-8835, pp. 1488–1492, 1992.
[2]
R. E. England, D. F. Martin, J. Morris et al., “A prospective randomised multicentre trial comparing 10 Fr Teflon Tannenbaum stents with 10 Fr polyethylene Cotton-Leung stents in patients with malignant common duct strictures,” Gut, vol. 46, no. 3, pp. 395–400, 2000.
[3]
Y. Igarashi, K. Ito, K. Miki et al., “The present and prospect of endoscopic biliary stenting,” Gastroenterological Endoscopy, vol. 50, no. 6, pp. 1427–1435, 2008 (Japanese), (with English abstract).
[4]
A. Tringali, M. Mutignani, V. Perri et al., “A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures,” Endoscopy, vol. 35, no. 12, pp. 992–997, 2003.
[5]
Y. H. Han, M. Y. Kim, S. Y. Kim et al., “Percutaneous insertion of Zilver stent in malignant biliary obstruction,” Abdominal Imaging, vol. 31, no. 4, pp. 433–438, 2006.
[6]
S. Okada, H. Ueno, T. Okusaka, M. Ikeda, J. Furuse, and Y. Maru, “Phase I trial of gemcitabine in patients with advanced pancreatic cancer,” Japanese Journal of Clinical Oncology, vol. 31, no. 1, pp. 7–12, 2001.
[7]
Y. Kikuchi, K. Ito, T. Mimura et al., “Analysis of prognostic factors among 57 patients with stage IV pancreatic cancer treated with gemcitabine,” Journal of the Medical Society of Toho University, vol. 56, no. 3, pp. 206–211, 2009 (Japanese), (with English abstract).
[8]
National Cancer Institute, “Common Terminology Criteria for Adverse Events v3.0 (CTCAE),” pp. 1–72, 2003, http://ctep.cancer.gov/reportiong/ctc_v30.html.
[9]
H. Isayama, I. Yasuda, S. Ryozawa, et al., “Results of a Japanese multicenter, randomized trial of endoscopic stenting for non-resectable pancreatic head cancer (JM-TEST): covered wallstent versus double layer stent,” Digestive Endoscopy, vol. 23, no. 4, pp. 310–31, 2011.
[10]
M. N. Schoeman and K. Huibregtse, “Pancreatic and ampullary carcinoma,” Gastrointestinal Endoscopy Clinics of North America, vol. 5, no. 1, pp. 217–236, 1995.
[11]
M. Kahaleh, J. Tokar, M. R. Conaway et al., “Efficacy and complications of covered Wallstents in malignant distal biliary obstruction,” Gastrointestinal Endoscopy, vol. 61, no. 4, pp. 528–533, 2005.
[12]
D. Schilling, G. Rink, J. C. Arnold et al., “Prospective, randomized, single-center trial comparing 3 different 10F plastic stents in malignant mid and distal bile duct strictures,” Gastrointestinal Endoscopy, vol. 58, no. 1, pp. 54–58, 2003.
[13]
P. P. Coene, A. K. Groen, J. Cheng, M. M. J. Out, G. N. J. Tytgat, and K. Huibregtse, “Clogging of biliary endoprostheses: a new perspective,” Gut, vol. 31, no. 8, pp. 913–917, 1990.
[14]
E. W. McAllister, L. C. Carey, P. G. Brady, R. Heller, and S. G. Kovacs, “The role of polymeric surface smoothness of biliary stents in bacterial adherence, biofilm deposition, and stent occlusion,” Gastrointestinal Endoscopy, vol. 39, no. 3, pp. 422–425, 1993.
[15]
N. Dowidar, H. J. Kolmos, H. Lyon, and P. Matzen, “Clogging of biliary endoprostheses. A morphologic and bacteriologic study,” Scandinavian Journal of Gastroenterology, vol. 26, no. 11, pp. 1137–1144, 1991.
[16]
U. Seitz, H. Vadeyar, and N. Soehendra, “Prolonged patency with a new-design teflon biliary prosthesis,” Endoscopy, vol. 26, no. 5, pp. 478–482, 1994.
[17]
V. Terruzzi, U. Comin, F. De Grazia et al., “Prospective randomized trial comparing Tannenbaum Teflon and standard polyethylene stents in distal malignant biliary stenosis,” Gastrointestinal Endoscopy, vol. 51, no. 1, pp. 23–27, 2000.
[18]
M. F. Catalano, J. E. Geenen, G. A. Lehman et al., “‘Tannenbaum’ Teflon stents versus traditional polyethylene stents for treatment of malignant biliary stricture,” Gastrointestinal Endoscopy, vol. 55, no. 3, pp. 354–358, 2002.
[19]
A. Tringali, M. Mutignani, V. Perri et al., “A prospective, randomized multicenter trial comparing double layer and polyethylene stents for malignant distal common bile duct strictures,” Endoscopy, vol. 35, no. 12, pp. 992–997, 2003.
[20]
J. Y. Sung, S. C. S. Chung, C. P. Tsui, A. L. Co, and A. K. C. Li, “Omitting side-holes in biliary stents does not improve drainage of the obstructed biliary system: a prospective randomized trial,” Gastrointestinal Endoscopy, vol. 40, no. 3, pp. 321–325, 1994.
[21]
A. M. Van Berkel, C. Boland, W. K. Redekop et al., “A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction,” Endoscopy, vol. 30, no. 8, pp. 681–686, 1998.
[22]
G. Costamagna, M. Mutignani, G. Rotondano et al., “Hydrophilic hydromer-coated polyurethane stents versus uncoated stents in malignant biliary obstruction: a randomized trial,” Gastrointestinal Endoscopy, vol. 51, no. 1, pp. 8–11, 2000.
[23]
K. Knyrim, H. J. Wagner, J. Pausch, and N. Vakil, “A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct,” Endoscopy, vol. 25, no. 3, pp. 207–212, 1993.
[24]
J. Lammer, K. A. Hausegger, F. Fluckiger et al., “Common bile duct obstruction due to malignancy: treatment with plastic versus metal stents,” Radiology, vol. 201, no. 1, pp. 167–172, 1996.
[25]
K. F. Binmoeller, U. Seitz, H. Seifert, F. Thonke, S. Sikka, and N. Soehendra, “The Tannenbaum stent: a new plastic biliary stent without side holes,” American Journal of Gastroenterology, vol. 90, no. 10, pp. 1764–1768, 1995.
[26]
F. Prat, O. Chapat, B. Ducot et al., “A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct,” Gastrointestinal Endoscopy, vol. 47, no. 1, pp. 1–7, 1998.
[27]
N. Hoepffner, E. C. Foerster, B. Hogemann, and W. Domschke, “Long-term experience in Wallstent therapy for malignant choledochal stenosis,” Endoscopy, vol. 26, no. 7, pp. 597–602, 1994.
[28]
C. S. Shim, Y. H. Lee, Y. D. Cho et al., “Preliminary results of a new covered biliary metal stent for malignant biliary obstruction,” Endoscopy, vol. 30, no. 4, pp. 345–350, 1998.
[29]
Y. Kubota, H. Mukai, A. Nakaizumi et al., “Covered wallstent for palliation of malignant common bile duct stricture: prospective multicenter evaluation,” Digestive Endoscopy, vol. 17, no. 3, pp. 218–223, 2005.
[30]
M. Kahaleh, J. Tokar, M. R. Conaway, et al., “Efficacy and complications of coveed Wallstents in malignant distal biliary obstruction,” Gastrointestinal Endoscopy, vol. 61, no. 4, pp. 528–533, 2005.
[31]
H. Isayama, Y. Komatsu, T. Tsujino et al., “Polyurethane-covered metal stent for management of distal malignant biliary obstruction,” Gastrointestinal Endoscopy, vol. 55, no. 3, pp. 366–370, 2002.
[32]
H. Isayama, Y. Komatsu, T. Tsujino et al., “A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction,” Gut, vol. 53, no. 5, pp. 729–734, 2004.
[33]
M. Kahaleh, J. Tokar, T. Le, et al., “Rremoval of self-expandable metallic Wallstents,” Gastrointestinal Endoscopy, vol. 60, no. 4, pp. 640–644, 2004.
[34]
W. J. Yoon, J. K. Lee, Y. B. Yoon et al., “A comparison of covered and uncovered Wallstents for the management of distal malignant biliary obstruction,” Gastrointestinal Endoscopy, vol. 63, no. 7, pp. 996–1000, 2006.
[35]
D. H. Park, M. H. Kim, S. K. Lee et al., “Covered versus uncovered wallstent for malignant extrahepatic biliary obstruction: a cohort comparative analysis,” Clinical Gastroenterology and Hepatology, vol. 4, no. 6, pp. 790–796, 2006.
[36]
J. C. Pereira-Lima, R. Jakobs, M. Maier, C. Benz, B. Kohler, and J. F. Riemann, “Endoscopic biliary stenting for the palliation of pancreatic cancer: results, survival predictive factors, and comparison of 10-French with 11.5-French gauge stents,” American Journal of Gastroenterology, vol. 91, no. 10, pp. 2179–2184, 1996.
[37]
F. Prat, O. Chapat, B. Ducot et al., “A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct,” Gastrointestinal Endoscopy, vol. 47, no. 1, pp. 1–7, 1998.
[38]
K. G. Yeoh, M. J. Zimmerman, J. T. Cunningham, et al., “Comparative costs of mental versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis,” Gastrointestinal Endoscopy, vol. 49, no. 4, pp. 466–471, 1999.
[39]
H. A. Burris III, M. J. Moore, J. Andersen et al., “Improvements in survival and clinical benefit with gemcitabine as first- line therapy for patients with advanced pancreas cancer: a randomized trial,” Journal of Clinical Oncology, vol. 15, no. 6, pp. 2403–2413, 1997.
