Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study

Background and study aims: Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction.

Patients and methods: A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS. 

Results: Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 – 92 days) for the winged stent and 80 days (range 28 – 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns.

Conclusions: The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction.

Study registration ClinicalTrials.gov (NCT01063634).

• References

• 1 Abraham NS, Barkun JS, Barkun AN. Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life. Gastrointest Endosc 2002; 56: 835-841
• 2 Davids PH, Groen AK, Rauws EA et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992; 340: 1488-1492
• 3 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
• 4 Schmassmann A, von Gunten E, Knuchel J et al. Wallstents versus plastic stents in malignant biliary obstruction: effects of stent patency of the first and second stent on patient compliance and survival. Am J Gastroenterol 1996; 91: 654-659
• 5 Dumonceau JM, Tringali A, Blero D et al. Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy 2012; 44: 277-298
• 6 Donelli G, Guaglianone E, Di Rosa R et al. Plastic biliary stent occlusion: factors involved and possible preventive approaches. Clin Med Res 2007; 5: 53-60
• 7 Catalano MF, Geenen JE, Lehman GA et al. “Tannenbaum” Teflon stents versus traditional polyethylene stents for treatment of malignant biliary stricture. Gastrointest Endosc 2002; 55: 354-358
• 8 Pereira-Lima JC, Jakobs R, Maier M et al. Endoscopic biliary stenting for the palliation of pancreatic cancer: results, survival predictive factors, and comparison of 10-French with 11.5-French gauge stents. Am J Gastroenterol 1996; 91: 2179-2184
• 9 van Berkel AM, Huibregtse IL, Bergman J et al. A prospective randomized trial of Tannenbaum-type Teflon-coated stents versus polyethylene stents for distal malignant biliary obstruction. Eur J Gastroenterol Hepatol 2004; 16: 213-217
• 10 van Berkel AM, Bruno MJ, Bergman JJ et al. A prospective randomized study of hydrophilic polymer-coated polyurethane versus polyethylene stents in distal malignant biliary obstruction. Endoscopy 2003; 35: 478-482
• 11 Deakin M, Fraser I, Smith K. A prospective randomized multicentre trial comparing 10 Fr polyethylene Cotton-Leung stents with 10 Fr polyethylene Cotton-Leung stents in patients with malignant common duct strictures. Gut 2000; 46: 395-400
• 12 Libby ED, Leung JW. Ultrasmooth plastic to prevent stent clogging. Gastrointest Endosc 1994; 40: 386-387
• 13 Raju GS, Sud R, Elfert AA et al. Biliary drainage by using stents without a central lumen: a pilot study. Gastrointest Endosc 2006; 63: 317-320
• 14 Levy MJ, Baron TH, Gostout CJ 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
• 15 ASGE Technology Assessment Committee. Pfau PR et al. Pancreatic and biliary stents. Gastrointest Endosc 2013; 77: 319-327
• 16 Dumonceau JM, Heresbach D, Devière J et al. Biliary stents: models and methods for endoscopic stenting. Endoscopy 2011; 43: 617-626
• 17 Khashab MA, Hutfless S, Kim K et al. A comparative evaluation of early stent occlusion among biliary conventional versus wing stents. Dig Dis Sci 2012; 57: 1708-1716
• 18 Telford 1 JJ, Carr-Locke DL, Baron TH et al. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc 2010; 72: 907-914
• 19 Kullman E, Frozanpor F, Söderlund C et al. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc 2010; 72: 915-923