Self-expandable metal stents versus plastic stents for malignant biliary obstruction: a meta-analysis

      Background

      Malignant biliary obstruction frequently portends a poor prognosis. Palliative treatment with stenting is often required to alleviate symptoms and potentially prevent adverse events.

      Objectives

      The aims of our study were (1) to evaluate the clinical difference between self-expandable metal stents (SEMSs) and plastic stents (PSs) in both hilar and distal malignant biliary obstruction on occlusion rate and 30-day mortality rate (primary outcomes) and stent insertion success rate, therapeutic failure, reintervention rate, and adverse events (secondary outcomes); (2) to compare unilateral stenting with bilateral stenting in hilar malignant obstruction in terms of occlusion rate and 30-day mortality rate (primary outcomes) and insertion success rate, therapeutic failure, and adverse events (secondary outcomes).

      Methods

      PubMed, Embase, and Cochrane databases were searched for studies that provided data about malignant biliary obstruction and stent therapy. We included randomized, controlled trials (RCT), prospective observational cohort, and retrospective case-control studies. The quality of each included RCT study was assessed by the Jadad scale. Mantel-Haenszel odds ratios (ORs) and mean differences were calculated by using a random-effects model.

      Results

      Nineteen studies involving 1989 patients (1045 SEMSs and 944 PSs) were included for the comparison of SEMSs and PSs. We also included 7 studies that compared unilateral with bilateral stenting involving 634 patients (346 unilateral and 268 bilateral). Our meta-analysis confirmed that SEMSs are associated with a statistically significant lower risk of occlusion compared with PSs in the short term (OR 0.27; 95% confidence interval [CI], 0.13-0.60) and long term (OR 0.38; 95% CI, 0.28-0.53). SEMSs had a lower 30-day occlusion rate than PSs in both hilar malignant obstruction (OR 0.16; 95% CI, 0.04-0.62) and distal malignant obstruction (OR 0.36; 95% CI, 0.14-0.93). SEMSs had a lower long-term occlusion rate compared with PSs in hilar malignant obstruction (OR 0.28; 95% CI, 0.19-0.39) and distal malignant obstruction (OR 0.42; 95% CI, 0.27-0.64). The 30-day mortality rate was similar with SEMSs and PSs (OR 0.74; 95% CI, 0.47-1.17). Therapeutic failure was more likely when using PSs (13%) compared with SEMSs (7%) (OR 0.43; 95% CI, 0.27-0.67). SEMSs required fewer reinterventions compared with PSs (mean difference, -0.49; 95% CI, -0.8 to -0.19). The incidence of cholangitis was statistically lower with SEMSs (8% vs 21%) (OR 0.41; 95% CI, 0.22-0.76). Bilateral stenting for hilar obstruction was not associated with a lower obstruction rate than unilateral stenting (OR 1.49; 95% CI, 0.77-2.89) or a lower 30-day mortality rate (OR 0.73; 95% CI, 0.29-1.79). There was no statistical difference in therapeutic failure (OR 1.47; 95% CI, 0.77-2.89) or cholangitis incidence (OR 0.61; 95% CI, 0.27-1.38).

      Conclusion

      SEMSs are associated with a statistically significantly lower occlusion rate, less therapeutic failure, less need for reintervention, and lower cholangitis incidence. There was no statistically significant difference in occlusion rate, therapeutic failure, and cholangitis incidence with bilateral stenting. Guideline recommendations may need to be modified to reflect clear and compelling data demonstrating the benefit of SEMSs in patients with malignant biliary obstruction. Bilateral stenting should be avoided because it has no benefit over unilateral stenting in terms of occlusion rate or therapeutic failure.

      Abbreviations:

      CI (confidence interval), I2 (inconsistency index), OR (odds ratio), PS (plastic stent), RCT (randomized, controlled trial), SEMS (self-expandable metal stent)
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      References

        • Kalser M.H.
        • Barkin J.
        • MacIntyre J.M.
        Pancreatic cancer. Assessment of prognosis by clinical presentation.
        Cancer. 1985; 56: 397-402
        • Shah J.N.
        • Muthusamy V.R.
        Endoscopic palliation of pancreaticobiliary malignancies.
        Gastrointest Endosc Clin N Am. 2005; 15 (ix): 513-531
        • Moss A.C.
        • Morris E.
        • Mac Mathuna P.
        Palliative biliary stents for obstructing pancreatic carcinoma.
        Cochrane Database Syst Rev. 2006; : CD004200
        • 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
        • 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
        • Ferreira L.E.
        • Baron T.H.
        Endoscopic stenting for palliation of malignant biliary obstruction.
        Expert Rev Med Devices. 2010; 7: 681-691
        • Cheng J.L.
        • Bruno M.J.
        • Bergman J.J.
        • et al.
        Endoscopic palliation of patients with biliary obstruction caused by nonresectable hilar cholangiocarcinoma: efficacy of self-expandable metallic Wallstents.
        Gastrointest Endosc. 2002; 56: 33-39
        • Pfau P.R.
        • Pleskow D.K.
        • Banerjee S.
        • et al.
        • ASGE Technology Assessment Committee
        Pancreatic and biliary stents.
        Gastrointest Endosc. 2013; 77: 319-327
        • Hong W.D.
        • Chen X.W.
        • Wu W.Z.
        • et al.
        Metal versus plastic stents for malignant biliary obstruction: an update meta-analysis.
        Clin Res Hepatol Gastroenterol. 2013; 37: 496-500
        • Lammer J.
        • Hausegger K.A.
        • Fluckiger F.
        • et al.
        Common bile duct obstruction due to malignancy: treatment with plastic versus metal stents.
        Radiology. 1996; 201: 167-172
        • Knyrim K.
        • Wagner H.J.
        • Pausch J.
        • et al.
        A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct.
        Endoscopy. 1993; 25: 207-212
        • Jadad A.R.
        • Moore R.A.
        • Carroll D.
        • et al.
        Assessing the quality of reports of randomized clinical trials: is blinding necessary?.
        Control Clin Trials. 1996; 17: 1-12
        • Liberati A.
        • Altman D.G.
        • Tetzlaff J.
        • et al.
        The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.
        Ann Intern Med. 2009; 151: W65-W94
        • Cotton P.B.
        • Lehman G.
        • Vennes J.
        • et al.
        Endoscopic sphincterotomy complications and their management: an attempt at consensus.
        Gastrointest Endosc. 1991; 37: 383-393
        • Hozo S.P.
        • Djulbegovic B.
        • Hozo I.
        Estimating the mean and variance from the median, range, and the size of a sample.
        BMC Med Res Methodol. 2005; 5: 13
        • Mukai T.
        • Yasuda I.
        • Nakashima M.
        • et al.
        Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial.
        J Hepatobiliary Pancreat Sci. 2013; 20: 214-222
        • Perdue D.G.
        • Freeman M.L.
        • DiSario J.A.
        • et al.
        Plastic versus self-expanding metallic stents for malignant hilar biliary obstruction: a prospective multicenter observational cohort study.
        J Clin Gastroenterol. 2008; 42: 1040-1046
        • Wagner H.J.
        • Knyrim K.
        • Vakil N.
        • et al.
        Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial.
        Endoscopy. 1993; 25: 213-218
        • Sangchan A.
        • Kongkasame W.
        • Pugkhem A.
        • et al.
        Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial.
        Gastrointest Endosc. 2012; 76: 93-99
        • Liberato M.J.
        • Canena J.M.
        Endoscopic stenting for hilar cholangiocarcinoma: efficacy of unilateral and bilateral placement of plastic and metal stents in a retrospective review of 480 patients.
        BMC Gastroenterol. 2012; 12: 103
        • Raju R.P.
        • Jaganmohan S.R.
        • Ross W.A.
        • et al.
        Optimum palliation of inoperable hilar cholangiocarcinoma: comparative assessment of the efficacy of plastic and self-expanding metal stents.
        Dig Dis Sci. 2011; 56: 1557-1564
        • Bismuth H.
        • Castaing D.
        • Traynor O.
        Resection or palliation: priority of surgery in the treatment of hilar cancer.
        World J Surg. 1988; 12: 39-47
        • Park S.B.
        • Kim H.W.
        • Kang D.H.
        • et al.
        Metallic or plastic stent for bile duct obstruction in ampullary cancer?.
        Dig Dis Sci. 2012; 57: 786-790
        • Weber A.
        • Mittermeyer T.
        • Wagenpfeil S.
        • et al.
        Self-expanding metal stents versus polyethylene stents for palliative treatment in patients with advanced pancreatic cancer.
        Pancreas. 2009; 38: e7-e12
        • Moses P.L.
        • Alnaamani K.M.
        • Barkun A.N.
        • et al.
        Randomized trial in malignant biliary obstruction: plastic vs partially covered metal stents.
        World J Gastroenterol. 2013; 19: 8638-8646
        • Soderlund C.
        • Linder S.
        Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial.
        Gastrointest Endosc. 2006; 63: 986-995
        • 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
        • Katsinelos P.
        • Paikos D.
        • Kountouras J.
        • 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: 1587-1593
        • Pinol V.
        • Castells A.
        • Bordas J.M.
        • et al.
        Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial.
        Radiology. 2002; 225: 27-34
        • Guo Y.X.
        • Li Y.H.
        • Chen Y.
        • et al.
        Percutaneous transhepatic metal versus plastic biliary stent in treating malignant biliary obstruction: a multiple center investigation.
        Hepatobiliary Pancreat Dis Int. 2003; 2: 594-597
        • Iwano H.
        • Ryozawa S.
        • Ishigaki N.
        • et al.
        Unilateral versus bilateral drainage using self-expandable metallic stent for unresectable hilar biliary obstruction.
        Dig Endosc. 2011; 23: 43-48
        • Naitoh I.
        • Ohara H.
        • Nakazawa T.
        • et al.
        Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction.
        J Gastroenterol Hepatol. 2009; 24: 552-557
        • Freeman M.L.
        • Overby C.
        Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents.
        Gastrointest Endosc. 2003; 58: 41-49
        • De Palma G.D.
        • Galloro G.
        • Siciliano S.
        • et al.
        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: 547-553
        • Chang W.H.
        • Kortan P.
        • Haber G.B.
        Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage.
        Gastrointest Endosc. 1998; 47: 354-362
        • Shah T.
        • Desai S.
        • Haque M.
        • et al.
        Management of occluded metal stents in malignant biliary obstruction: similar outcomes with second metal stents compared to plastic stents.
        Dig Dis Sci. 2012; 57: 2765-2773
        • 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
        • 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
        • Carr Locke D.L.
        • Ball J.J.
        • Connors P.J.
        • et al.
        Multicentre randomised trial of wallstent biliary endoprosthesis versus plastic stents.
        Gastrointest Endosc. 1993; 39: 310-316

      Linked Article

      • Hilar stenting for malignant biliary obstruction
        Gastrointestinal EndoscopyVol. 83Issue 2
        • Preview
          Sawas et al1 elegantly present the case for the use of self-expandable metal stents to palliate malignant biliary obstruction. However, in their analysis in relation to unilateral or bilateral stenting to palliate malignant hilar obstruction, their conclusions are not fully supported by the data provided. Their data for bilateral or unilateral hilar stenting are derived from 7 studies, 3 of which are fairly dated (Chang et al,2 De Palma et al,3 and Freeman and Overby4) and provide their 30-day mortality data (Chang et al2 and De Palma et al3).
        • Full-Text
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      • Self-expandable metal stents versus plastic stents for malignant biliary obstruction
        Gastrointestinal EndoscopyVol. 83Issue 4
        • Preview
          We read with interest the meta-analysis by Sawas et al1 comparing self-expandable metal stents (SEMSs) and plastic stents for malignant biliary obstruction. We commend the authors on their effort and agree that although the notion based on current evidence does appear to favor SEMSs, there is a need to quantify the added benefit and better characterize the best intervention for individual patients. We see this as an opportunity to highlight important methodologic considerations in the performance of meta-analyses and to raise a few issues:
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