Self-expandable metallic stent placement above the papilla without endoscopic sphincterotomy in patients with distal malignant biliary obstruction

Abstract

Background and study aims The best method for endoscopic placement of self-expandable metallic stents (SEMS) for distal malignant biliary obstruction (MBO) has not yet been determined. The aim of this study was to evaluate how SEMS placement above the papilla and without endoscopic sphincterotomy (EST) impacts the time to recurrent biliary obstruction (RBO) in patients with distal MBO.

Patients and methods We retrospectively reviewed data for 73 consecutive patients with unresectable distal MBO who underwent endoscopic SEMS placement for the first time at our institution between April 2014 and March 2016. We compared time to RBO of SEMS placement above the papilla (intraductal placement) with SEMS placement across the papilla (transpapillary placement). In the intraductal placement group, we also compared time to RBO of placement without EST with placement with EST.

Results Endoscopic SEMS placement was performed in 30 patients with intraductal placement and in 43 patients with transpapillary placement. The median time to RBO was significantly longer with intraductal placement (307 days) than with transpapillary placement (161 days) (P = 0.022). Complication rates did not differ between the two groups. In both univariate and multivariate analysis, intraductal placement was an independent factor contributing to prolonged time to RBO. In intraductal placement, time to RBO was significantly longer in SEMS placement without EST than with EST (363 days vs. 227 days, respectively; P = 0.026).

Conclusions Intraductal SEMS placement, especially without EST for distal MBO contributed to longer time to RBO.

Publication History

Received: 25 September 2019

Accepted: 19 February 2020

Article published online:
25 May 2020

• References

• 1 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
• 2 Wagner HJ, 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
• 3 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
• 4 Kitano M, Yamashita Y, Tanaka K. et al. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol 2013; 108: 1713-1722
• 5 Li J, Li T, Sun P. et al. Covered versus uncovered self-expandable metal stents for managing malignant distal biliary obstruction: a meta-analysis. PLoS One 2016; 11: e0149066
• 6 Conio M, Mangiavillano B, Caruso A. et al. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc 2018; 88: 283-291
• 7 Choi H, Moon J, Lee Y. et al. 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. Endoscopy 2016; 48: 625-631
• 8 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; 77: AB139-AB140
• 9 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
• 10 Okano N, Igarashi Y, Kishimoto Y. et al. Necessity for endoscopic sphincterotomy for biliary stenting in cases of malignant biliary obstruction. Dig Endosc 2013; 25: 122-125
• 11 Hayashi T, Kawakami H, Osanai M. et al. No benefit of endoscopic sphincterotomy before biliary placement of self-expandable metal stents for unresectable pancreatic cancer. Clin Gastroenterol Hepatol 2015; 13: 1151-1158
• 12 Banerjee N, Hilden K, Baron TH. et al. Endoscopic biliary sphincterotomy is not required for transpapillary sems placement for biliary obstruction. Dig Dis Sci 2011; 56: 591-595
• 13 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
• 14 Mangiavillano B, Montale A, Frazzoni L. et al. Endoscopic biliary self-expandable metallic stent in malignant biliary obstruction with or without sphincterotomy: systematic review and meta-analysis. Endosc Int Open 2019; 7: E26-E35
• 15 Zhou H, Li L, Zhu F. et al. Endoscopic sphincterotomy associated cholangitis in patients receiving proximal biliary self-expanding metal stents. Hepatobiliary Pancreat Dis Int 2012; 11: 643-649
• 16 Isayama H, Hamada T, Yasuda I. et al. Tokyo criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015; 27: 259-264
• 17 Yokoe M, Hata J, Takada T. et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci 2018; 25: 41-54
• 18 Dumonceau J-M, Tringali A, Papanikolaou I. et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – Updated October 2017. Endoscopy 2018; 50: 910-930
• 19 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
• 20 Kogure H, Ryozawa S, Maetani I. et al. A prospective multicenter study of a fully covered metal stent in patients with distal malignant biliary obstruction: WATCH-2 Study. Dig Dis Sci 2018; 63: 2466-2473
• 21 Huang X, Shen L, Jin Y. et al. Comparison of uncovered stent placement across versus above the main duodenal papilla for malignant biliary obstruction. J Vasc Interv Radiol 2015; 26: 432-437
• 22 Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc 2009; 70: 317-321
• 23 Kubota K, Hasegawa S, Iwasaki A. et al. Stent placement above the sphincter of Oddi permits implementation of neoadjuvant chemotherapy in patients with initially unresectable Klatskin tumor. Endosc Int Open 2016; 04: E427-E433
• 24 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
• 25 Kurita A, Kodama Y, Minami R. et al. Endoscopic stent placement above the intact sphincter of Oddi for biliary strictures after living donor liver transplantation. J Gastroenterol 2013; 48: 1097-1104