Skip to main content
Top
Published in: Journal of Hepato-Biliary-Pancreatic Sciences 2/2013

01-02-2013 | Original article

Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial

Authors: Tsuyoshi Mukai, Ichiro Yasuda, Masanori Nakashima, Shinpei Doi, Takuji Iwashita, Keisuke Iwata, Tomohiro Kato, Eiichi Tomita, Hisataka Moriwaki

Published in: Journal of Hepato-Biliary-Pancreatic Sciences | Issue 2/2013

Login to get access

Abstract

Background

Endoscopic biliary stenting is a well-established palliative treatment for unresectable malignant biliary strictures, for which plastic tube stents (PSs) and self-expandable metallic stents (SEMSs) are most commonly used. The efficacy of these stents has been extensively described in distal biliary strictures, but not in hilar biliary strictures. The present study aimed to compare the efficacy of PSs and SEMSs for unresectable malignant hilar biliary strictures.

Methods

From June 2004 to November 2008, 60 patients were enrolled and prospectively randomized into the PS or SEMS group.

Results

The 6-month patency rate was significantly higher in the SEMS group than in the PS group (81 vs. 20%; p = 0.0012). Kaplan–Meier analysis showed significantly longer patency in the SEMS group than in the PS group (p = 0.0002); the 50% patency period was 359 days in the SEMS group and 112 days in the PS group. There was no significant difference in the overall survival period between the PS and SEMS groups (p = 0.2834). The mean number of reinterventions for stent failures was significantly lower in the SEMS group (0.63 times/patient) than in the PS group (1.80 times/patient) (p = 0.0008). The overall total cost for the treatment was significantly lower in the SEMS group than in the PS group (p = 0.0222).

Conclusions

SEMSs were associated with a longer patency than PSs in patients with unresectable hilar biliary stricture. SEMSs were also more advantageous in reducing the number of reintervention sessions and the overall treatment cost.
Literature
1.
go back to reference Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992;340:1488–92.PubMedCrossRef Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992;340:1488–92.PubMedCrossRef
2.
go back to reference Knyrim K, Wagner HJ, 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.PubMedCrossRef Knyrim K, Wagner HJ, 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.PubMedCrossRef
3.
go back to reference Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J, et al. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc. 1998;47:1–7.PubMedCrossRef Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J, et al. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc. 1998;47:1–7.PubMedCrossRef
4.
go back to reference Arguedas MR, Heudebert GH, Stinnett AA, Wilcox CM. Biliary stents in malignant obstructive jaundice due to pancreatic carcinoma: a cost-effectiveness analysis. Am J Gastroenterol. 2002;97:898–904.PubMedCrossRef Arguedas MR, Heudebert GH, Stinnett AA, Wilcox CM. Biliary stents in malignant obstructive jaundice due to pancreatic carcinoma: a cost-effectiveness analysis. Am J Gastroenterol. 2002;97:898–904.PubMedCrossRef
5.
go back to reference Kaassis M, Boyer J, Dumas R, Ponchon T, Coumaros D, Delcenserie R, et al. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc. 2003;57:178–82.PubMedCrossRef Kaassis M, Boyer J, Dumas R, Ponchon T, Coumaros D, Delcenserie R, et al. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc. 2003;57:178–82.PubMedCrossRef
6.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
7.
go back to reference Levy MJ, Baron TH, Gostout CJ, Petersen BT, Farnell MB. Palliation of malignant extrahepatic biliary obstruction with plastic versus expandable metal stents: an evidence-based approach. Clin Gastroenterol Hepatol. 2004;2:273–85.PubMedCrossRef Levy MJ, Baron TH, Gostout CJ, Petersen BT, Farnell MB. Palliation of malignant extrahepatic biliary obstruction with plastic versus expandable metal stents: an evidence-based approach. Clin Gastroenterol Hepatol. 2004;2:273–85.PubMedCrossRef
8.
go back to reference Katsinelos P, Paikos D, Kountouras J, Chatzimavroudis G, Paroutoglou G, Moschos I, et al. Tannenbaum and metal stents in the palliative treatment of malignant distal bile duct obstruction: a comparative study of patency and cost effectiveness. Surg Endosc. 2006;20:1587–93.PubMedCrossRef Katsinelos P, Paikos D, Kountouras J, Chatzimavroudis G, Paroutoglou G, Moschos I, et al. Tannenbaum and metal stents in the palliative treatment of malignant distal bile duct obstruction: a comparative study of patency and cost effectiveness. Surg Endosc. 2006;20:1587–93.PubMedCrossRef
9.
go back to reference Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc. 2006;63:986–95.PubMedCrossRef Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc. 2006;63:986–95.PubMedCrossRef
10.
go back to reference Moss AC, Morris E, Leyden J, MacMathuna P. Malignant distal biliary obstruction: a systematic review and meta-analysis of endoscopic and surgical bypass results. Cancer Treat Rev. 2007;33:213–21.PubMedCrossRef Moss AC, Morris E, Leyden J, MacMathuna P. Malignant distal biliary obstruction: a systematic review and meta-analysis of endoscopic and surgical bypass results. Cancer Treat Rev. 2007;33:213–21.PubMedCrossRef
11.
go back to reference Moss AC, Morris E, Leyden J, MacMathuna P. Do the benefits of metal stents justify the costs? A systematic review and meta-analysis of trials comparing endoscopic stents for malignant biliary obstruction. Eur J Gastroenterol Hepatol. 2007;19:1119–24.PubMedCrossRef Moss AC, Morris E, Leyden J, MacMathuna P. Do the benefits of metal stents justify the costs? A systematic review and meta-analysis of trials comparing endoscopic stents for malignant biliary obstruction. Eur J Gastroenterol Hepatol. 2007;19:1119–24.PubMedCrossRef
12.
go back to reference Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993;25:213–8.PubMedCrossRef Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993;25:213–8.PubMedCrossRef
13.
go back to reference Perdue DG, Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, et al. Plastic versus self-expanding metallic stents for malignant hilar biliary obstruction: a prospective multicenter observational cohort study. J Clin Gastroenterol. 2008;42:1040–6.PubMedCrossRef Perdue DG, Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, et al. Plastic versus self-expanding metallic stents for malignant hilar biliary obstruction: a prospective multicenter observational cohort study. J Clin Gastroenterol. 2008;42:1040–6.PubMedCrossRef
14.
go back to reference Maguchi H, Takahashi K, Katanuma A, Osanai M, Nakahara K, Matuzaki S, et al. Preoperative biliary drainage for hilar cholangiocarcinoma. J Hepatobiliary Pancreat Surg. 2007;14:441–6.PubMedCrossRef Maguchi H, Takahashi K, Katanuma A, Osanai M, Nakahara K, Matuzaki S, et al. Preoperative biliary drainage for hilar cholangiocarcinoma. J Hepatobiliary Pancreat Surg. 2007;14:441–6.PubMedCrossRef
15.
go back to reference Kawakami H, Kondo S, Kuwatani M, Yamato H, Ehira N, Kudo T, et al. Preoperative biliary drainage for hilar cholangiocarcinoma: which stent should be selected? J Hepatobiliary Pancreat Sci. 2011;18:630–5.PubMedCrossRef Kawakami H, Kondo S, Kuwatani M, Yamato H, Ehira N, Kudo T, et al. Preoperative biliary drainage for hilar cholangiocarcinoma: which stent should be selected? J Hepatobiliary Pancreat Sci. 2011;18:630–5.PubMedCrossRef
16.
go back to reference Kawamoto H, Tsutsumi K, Harada R, Fujii M, Kato H, Hirao K, et al. Endoscopic deployment of multiple JOSTENT SelfX is effective and safe in treatment of malignant hilar biliary strictures. Clin Gastroenterol Hepatol. 2008;6:401–8.PubMedCrossRef Kawamoto H, Tsutsumi K, Harada R, Fujii M, Kato H, Hirao K, et al. Endoscopic deployment of multiple JOSTENT SelfX is effective and safe in treatment of malignant hilar biliary strictures. Clin Gastroenterol Hepatol. 2008;6:401–8.PubMedCrossRef
17.
go back to reference Chahal P, Baron TH. Expandable metal stents for endoscopic bilateral stent-within-stent placement for malignant hilar biliary obstruction. Gastrointest Endosc. 2010;71:195–9.PubMedCrossRef Chahal P, Baron TH. Expandable metal stents for endoscopic bilateral stent-within-stent placement for malignant hilar biliary obstruction. Gastrointest Endosc. 2010;71:195–9.PubMedCrossRef
18.
go back to reference Lee BH, Choe DH, Lee JH, Kim KH, Chin SY. Metallic stents in malignant biliary obstruction: prospective long-term clinical results. AJR Am J Roentgenol. 1997;168:741–5.PubMed Lee BH, Choe DH, Lee JH, Kim KH, Chin SY. Metallic stents in malignant biliary obstruction: prospective long-term clinical results. AJR Am J Roentgenol. 1997;168:741–5.PubMed
19.
go back to reference Chang WH, Kortan P, Haber GB. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage. Gastrointest Endosc. 1998;47:354–62.PubMedCrossRef Chang WH, Kortan P, Haber GB. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage. Gastrointest Endosc. 1998;47:354–62.PubMedCrossRef
20.
go back to reference Naitoh I, Ohara H, Nakazawa T, Ando T, Hayashi K, Okumura F, et al. Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction. J Gastroenterol Hepatol. 2009;24:552–7.PubMedCrossRef Naitoh I, Ohara H, Nakazawa T, Ando T, Hayashi K, Okumura F, et al. Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction. J Gastroenterol Hepatol. 2009;24:552–7.PubMedCrossRef
21.
go back to reference De Palma GD, Galloro G, Siciliano S, Iovino P, Catanzano C. Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized, and controlled study. Gastrointest Endosc. 2001;53:547–53.PubMedCrossRef De Palma GD, Galloro G, Siciliano S, Iovino P, Catanzano C. Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized, and controlled study. Gastrointest Endosc. 2001;53:547–53.PubMedCrossRef
22.
go back to reference De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, et al. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003;58:50–3.PubMedCrossRef De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, et al. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003;58:50–3.PubMedCrossRef
23.
go back to reference Dowsett JF, Vaira D, Hatfield AR, Cairns SR, Polydorou A, Frost R, et al. Endoscopic biliary therapy using the combined percutaneous and endoscopic technique. Gastroenterology. 1989;96:1180–6.PubMed Dowsett JF, Vaira D, Hatfield AR, Cairns SR, Polydorou A, Frost R, et al. Endoscopic biliary therapy using the combined percutaneous and endoscopic technique. Gastroenterology. 1989;96:1180–6.PubMed
24.
go back to reference Larghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol. 2008;103:458–73.PubMedCrossRef Larghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol. 2008;103:458–73.PubMedCrossRef
25.
go back to reference Costamagna G, Tringali A, Petruzziello L, Spada C. Hilar tumours. Can J Gastroenterol. 2004;18:451–4.PubMed Costamagna G, Tringali A, Petruzziello L, Spada C. Hilar tumours. Can J Gastroenterol. 2004;18:451–4.PubMed
26.
go back to reference Uchida N, Tsutsui K, Ezaki T, Fukuma H, Kamata H, Kobara H, et al. Estimation of the stent placement above the intact sphincter of Oddi against malignant bile duct obstruction. J Gastroenterol. 2005;40:291–6.PubMedCrossRef Uchida N, Tsutsui K, Ezaki T, Fukuma H, Kamata H, Kobara H, et al. Estimation of the stent placement above the intact sphincter of Oddi against malignant bile duct obstruction. J Gastroenterol. 2005;40:291–6.PubMedCrossRef
Metadata
Title
Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial
Authors
Tsuyoshi Mukai
Ichiro Yasuda
Masanori Nakashima
Shinpei Doi
Takuji Iwashita
Keisuke Iwata
Tomohiro Kato
Eiichi Tomita
Hisataka Moriwaki
Publication date
01-02-2013
Publisher
Springer Japan
Published in
Journal of Hepato-Biliary-Pancreatic Sciences / Issue 2/2013
Print ISSN: 1868-6974
Electronic ISSN: 1868-6982
DOI
https://doi.org/10.1007/s00534-012-0508-8

Other articles of this Issue 2/2013

Journal of Hepato-Biliary-Pancreatic Sciences 2/2013 Go to the issue