Subscribe to RSS
Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled studyTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03439020 Type of study: prospective randomized multi-center study
Background Two types of self-expandable metal stents (SEMS) are available for malignant distal biliary obstruction: fully covered SEMS (FCSEMS) and uncovered SEMS. FCSEMS can prevent stent ingrowth, but a major concern is spontaneous migration. This study aimed to determine whether the additional insertion of a double-pigtail plastic stent to anchor the FCSEMS can prevent migration.
Methods 68 patients with unresectable, malignant, distal, biliary obstruction were included in this multicenter, randomized, superiority trial. The patients were randomly assigned to receive either the FCSEMS plus an anchoring plastic stent (n = 33) or an FCSEMS alone (n = 35). After placement of the FCSEMS, the anchoring stent was inserted inside the FCSEMS. The primary outcome was the rate of stent migration during the 6-month follow-up. The secondary outcomes were stent-related adverse events, stent patency, and survival rates.
Results The baseline characteristics were similar between the two groups. The rate of stent migration at 6 months was significantly lower in patients with the FCSEMS plus anchoring stent (15 % vs. 40 %; P = 0.02). The mean stent patency was significantly longer in the FCSEMS plus anchoring group (237 days [95 % confidence interval [CI] 199 to 275] vs. 173 days [95 %CI 130 to 217]; P = 0.048). There were no significant differences in stent-related adverse events and overall survival rates at 6 months between the two groups.
Conclusions Our data suggest that the additional double-pigtail plastic stent anchored the FCSEMS to prevent migration and prolonged patency without any serious adverse events.
Received: 02 June 2020
Accepted: 04 September 2020
04 September 2020 (online)
© 2020. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Smith AC, Dowsett JF, Russell RC. et al. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction. Lancet 1994; 344: 1655-1660
- 2 Moy BT, Birk JW. An update to hepatobiliary stents. J Clin Transl Hepatol 2015; 3: 67-77
- 3 Huibregtse K, Cheng J, Coene PP. et al. Endoscopic placement of expandable metal stents for biliary strictures – a preliminary report on experience with 33 patients. Endoscopy 1989; 21: 280-282
- 4 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
- 5 Pfau RR, Pleskow DK, Banerjee S. et al. Pancreatic and biliary stents. Gastrointest Endosc 2013; 77: 319-327
- 6 Isayama H, Komatsu Y, Tsujino T. et al. Polyurethane-covered metal stent for management of distal malignant biliary obstruction. Gastrointest Endosc 2002; 55: 366-370
- 7 Tringali A, Hassan C, Rota M. et al. Covered vs. uncovered self-expandable metal stents for malignant distal biliary strictures: a systematic review and meta-analysis. Endoscopy 2018; 50: 631-641
- 8 Almadi MA, Barkun AN, Martel M. No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol 2013; 11: 27-37.e21
- 9 Emhmed AliS, Frandah WM, Su L. et al. Should a fully covered self-expandable biliary metal stent be anchored with a double-pigtail plastic stent? A retrospective study. World J Gastrointest Endosc 2019; 11: 365-372
- 10 Park DH, Lee SS, Lee TH. et al. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos). Gastrointest Endosc 2011; 73: 64-70
- 11 Mahajan A, Ho H, Sauer B. et al. Temporary placement of fully covered self-expandable metal stents in benign biliary strictures: midterm evaluation (with video). Gastrointest Endosc 2009; 70: 303-309
- 12 Wang AY, Ellen K, Berg CL. et al. Fully covered self-expandable metallic stents in the management of complex biliary leaks: preliminary data – a case series. Endoscopy 2009; 41: 781-786
- 13 Park JK, Moon JH, Choi HJ. et al. Anchoring of a fully covered self-expandable metal stent with a 5F double-pigtail plastic stent to prevent migration in the management of benign biliary strictures. Am J Gastroenterol 2011; 106: 1761-1765
- 14 Katsinelos P, Lazaraki G, Gkagkalis S. et al. A fully covered self-expandable metal stent anchored by a 10-Fr double pigtail plastic stent: an effective anti-migration technique. Ann Gastroenterol 2017; 30: 114-117
- 15 Paik WH, Lee TH, Park DH. et al. EUS-guided biliary drainage versus ERCP for the primary palliation of malignant biliary obstruction: a multicenter randomized clinical trial. Am J Gastroenterol 2018; 113: 987-997
- 16 Kahaleh M, Sundaram V, Condron SL. et al. Temporary placement of covered self-expandable metallic stents in patients with biliary leak: midterm evaluation of a pilot study. Gastrointest Endosc 2007; 66: 52-59
- 17 Ho H, Mahajan A, Gosain S. et al. Management of complications associated with partially covered biliary metal stents. Dig Dis Sci 2010; 55: 516-522
- 18 Chandrasekhara V, Khashab MA. ASGE Standards of Practice Committee. et al. Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32-47
- 19 Paik WH, Park YS, Hwang JH. et al. Palliative treatment with self-expandable metallic stents in patients with advanced type III or IV hilar cholangiocarcinoma: a percutaneous versus endoscopic approach. Gastrointest Endosc 2009; 69: 55-62
- 20 Nakai Y, Isayama H, Kogure H. et al. Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer. J Gastroenterol Hepatol 2014; 29: 1744-1749
- 21 Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc 2009; 70: 317-321
- 22 Isayama H, Mukai T, Itoi T. et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointest Endosc 2012; 76: 84-92
- 23 Yang MJ, Kim JH, Yoo BM. et al. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: a randomized controlled trial. Scand J Gastroenterol 2015; 50: 1490-1499
- 24 Behm B, Brock A, Clarke BW. et al. Partially covered self-expandable metallic stents for benign biliary strictures due to chronic pancreatitis. Endoscopy 2009; 41: 547-551
- 25 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
- 26 Kawakubo K, Isayama H, Nakai Y. et al. Risk factors for pancreatitis following transpapillary self-expandable metal stent placement. Surg Endosc 2012; 26: 771-776