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DOI: 10.1055/s-0042-105643
Evaluation of a newly modified nonflared fully covered metal stent, 12 mm in diameter, for intraductal placement in patients with malignant biliary strictures: a feasibility study
Publikationsverlauf
submitted 19. November 2015
accepted after revision 29. Februar 2016
Publikationsdatum:
25. April 2016 (online)
![](https://www.thieme-connect.de/media/endoscopy/201607/lookinside/thumbnails/13509_10-1055-s-0042-105643-1.jpg)
Background and study aim: The nonflared ends of fully covered, self-expandable, metal stents (FCSEMSs) may minimize stent-induced ductal injury. Suprapapillary intraductal placement of nonflared FCSEMSs for malignant biliary stricture might reduce duodenobiliary reflux and pancreatitis. The aim of this study was to evaluate the efficacy of a newly modified, nonflared FCSEMS for intraductal placement in patients with malignant biliary stricture.
Patients and methods: A total of 51 patients with nonhilar, extrahepatic, malignant biliary stricture were enrolled prospectively. The nonflared FCSEMS is 12 mm in diameter, and has a central saddle and a distal lasso of 7 cm in length. An FCSEMS was placed above the papilla in all patients, with the central saddle positioned at the stricture to prevent stent migration.
Results: The technical and clinical success rates were 100 % and 98 %, respectively. Early adverse events occurred in one patient (2.0 %; mild pancreatitis). A total of 12 patients underwent surgery with curative intent, one of whom (8.3 %) experienced a postoperative adverse event. No stent migration occurred in any of the patients. Cholecystitis developed in one patient (2.0 %) as a late adverse event. Stent occlusion occurred in 44.7 % (17/38), and endoscopic removal of the stent was successful in 87.5 % of patients. The mean stent patency was 297 days (95 % confidence interval, 211 – 383).
Conclusions: Intraductal placement of the nonflared FCSEMS, 12 mm in diameter, was feasible for the palliative and preoperative management of patients with malignant biliary stricture. Long-term follow-up and prospective comparative studies are needed to evaluate the usefulness of intraductal placement of this stent.
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References
- 1 Smith AC, Dowsett JF, Russell RC et al. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction. Lancet 1994; 344: 1655-1660
- 2 Isayama H, Komatsu Y, Tsujino T et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53: 729-734
- 3 Kasher JA, Corasanti JG, Tarnasky PR et al. A multicenter analysis of safety and outcome of removal of a fully covered self-expandable metal stent during ERCP. Gastrointest Endosc 2011; 73: 1292-1297
- 4 Isayama H, Nakai Y, Kawakubo K et al. Endoscopic retrograde cholangiopancreatography for distal malignant biliary stricture. Gastrointest Endosc Clin N Am 2012; 22: 479-490
- 5 Deviere J, Nageshwar Reddy D, Puspok A et al. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology 2014; 147: 385-395
- 6 Okamoto T, Fujioka S, Yanagisawa S et al. Placement of a metallic stent across the main duodenal papilla may predispose to cholangitis. Gastrointest Endosc 2006; 63: 792-796
- 7 Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc 2009; 70: 317-321
- 8 Zhang R, Luo H, Pan Y et al. Rate of duodenal-biliary reflux increases in patients with recurrent common bile duct stones: evidence from barium meal examination. Gastrointest Endosc 2015; 82: 660-665
- 9 Silvis SE, Sievert Jr CE, Vennes JA et al. Comparison of covered versus uncovered wire mesh stents in the canine biliary tract. Gastrointest Endosc 1994; 40: 17-21
- 10 Wang A, Ellen K, Berg C 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
- 11 Geoghegan J, Branch M, Costerton J et al. Biliary stents occlude earlier if the distal tip is in the duodenum in dogs. Gastrointest Endosc 1991; 37: 257
- 12 Uchida N, Tsutsui K, Ezaki T et al. Estimation of the stent placement above the intact sphincter of Oddi against malignant bile duct obstruction. J Gastroenterol 2005; 40: 291-296
- 13 Moon JH, Choi HJ, Koo HC et al. Feasibility of placing a modified fully covered self-expandable metal stent above the papilla to minimize stent-induced bile duct injury in patients with refractory benign biliary strictures (with videos). Gastrointest Endosc 2012; 75: 1080-1085
- 14 Moon S-H, Kim M-H, Park DH et al. Modified fully covered self-expandable metal stents with antimigration features for benign pancreatic-duct strictures in advanced chronic pancreatitis, with a focus on the safety profile and reducing migration. Gastrointest Endosc 2010; 72: 86-91
- 15 Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
- 16 Isayama H, Hamada T, Yasuda I et al. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015; 27: 259-264
- 17 Siddiqui AA, Mehendiratta V, Loren D et al. Fully covered self-expandable metal stents are effective and safe to treat distal malignant biliary strictures, irrespective of surgical resectability status. J Clin Gastroenterol 2011; 45: 824-827
- 18 Bethge N, Sommer A, Gross U et al. Human tissue responses to metal stents implanted in vivo for the palliation of malignant stenoses. Gastrointest Endosc 1996; 43: 596-602
- 19 Pedersen FM, Lassen AT, Schaffalitzky de Muckadell OB. Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction. Gastrointest Endosc 1998; 48: 574-579
- 20 Cho JN, Han J, Kim HG et al. Prospective randomized trial comparing covered metal stent placed above and across the sphincter of Oddi in malignant biliary obstruction. Gastrointest Endosc 2013; 5: AB139-AB140
- 21 Hu B, Wang TT, Wu J et al. Antireflux stents to reduce the risk of cholangitis in patients with malignant biliary strictures: a randomized trial. Endoscopy 2014; 46: 120-126
- 22 Lee YN, Moon JH, Choi HJ et al. Effectiveness of a newly designed antireflux valve metal stent to reduce duodenobiliary reflux in patients with unresectable distal malignant biliary obstruction: a randomized controlled pilot study (with videos). Gastrointest Endosc 2016; 83: 404-412
- 23 Kahaleh M, Talreja JP, Loren DE et al. Evaluation of a fully covered self-expanding metal stent with flared ends in malignant biliary obstruction: a multicenter study. J Clin Gastroenterol 2013; 47: e96-100
- 24 van der Gaag NA, Rauws EA, van Eijck CH et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med 2010; 362: 129-137
- 25 Siddiqui AA, Mehendiratta V, Loren D et al. Self-expanding metal stents (SEMS) for preoperative biliary decompression in patients with resectable and borderline-resectable pancreatic cancer: outcomes in 241 patients. Dig Dis Sci 2013; 58: 1744-1750
- 26 Tol JA, van Hooft JE, Timmer R et al. Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer. Gut 2015; DOI: 10.1136/gutjnl-2014-308762.
- 27 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