Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study

Abstract

Background and study aims We developed a self-expandable metallic stent (SEMS) with a distal tapered end to reproduce the physiological bile flow with a pressure gradient due to the difference in the diameter. We aimed to evaluate the safety and efficacy of the newly developed distal tapered covered metal stent (TMS) for distal malignant biliary obstruction (DMBO).

Patients and methods This single-center, prospective, single-arm study was conducted in patients with DMBO. The primary endpoint was time to recurrent biliary obstruction (TRBO), and the secondary endpoints were the survival time and incidence of adverse events (AEs).

Results Thirty-five patients (15 men, 20 women; median age, 81 years [range: 53–92]) were enrolled between December 2017 and December 2019. The primary diseases were pancreatic head cancer in 25 cases, bile duct cancer in eight cases, and ampullary cancer in two cases. TMS was successfully placed in all cases. Acute cholecystitis occurred as an early AE (within 30 days) in two cases (5.7 %). The median TRBO was 503 days, median survival time was 239 days. RBO was observed in 10 cases (28.6 %), and the causes were distal migration in six cases, proximal migration in two cases, biliary sludge in one case, and tumor overgrowth in one case.

Conclusions Endoscopic placement of the newly developed TMS in patients with DMBO is technically feasible and safe, and the TRBO was remarkably long. The anti-reflux mechanism based on the difference in diameter may be effective, and a randomized controlled trial with a conventional SEMS is required.

Publication History

Received: 07 July 2022

Accepted after revision: 15 February 2023

Accepted Manuscript online:
21 February 2023

Article published online:
09 May 2023

• References

• 1 Davids PHP, Groen AK, Rauws EAJ. et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992; 340: 1488-1492
• 2 Knyrim K, Wagner HJ, 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
• 3 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
• 4 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
• 5 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
• 6 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-e100
• 7 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
• 8 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
• 9 Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc 2009; 70: 317-321
• 10 Loew BJ, Howell DA, Sanders MK. et al. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc 2009; 70: 445-453
• 11 Hu B, Wang T-T, Shi Z-M. et al. A novel antireflux metal stent for the palliation of biliary malignancies: a pilot feasibility study (with video). Gastrointest Endosc 2011; 73: 143-148
• 12 Lee KJ, Chung MJ, Park JY. et al. Clinical advantages of a metal stent with an S-shaped anti-reflux valve in malignant biliary obstruction: Anti-reflux valve biliary metal stent. Digestive Endoscopy 2013; 25: 308-312
• 13 Kim DU, Kwon C, Kang DH. et al. New antireflux self‐expandable metal stent for malignant lower biliary obstruction: In vitro and in vivo preliminary study. Digestive Endoscopy 2013; 25: 60-66
• 14 Hamada T, Isayama H, Nakai Y. et al. Novel antireflux covered metal stent for recurrent occlusion of biliary metal stents: A pilot study: ARMS for recurrent occlusion. Digestive Endoscopy 2014; 26: 264-269
• 15 Hu B, Wang T, 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
• 16 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
• 17 Hamada T, Isayama H, Nakai Y. et al. Antireflux metal stent as a first-line metal stent for distal malignant biliary obstruction: a pilot study. Gut Liver 2017; 11: 142-148
• 18 Morita S, Arai Y, Sugawara S. et al. Antireflux metal stent for initial treatment of malignant distal biliary obstruction. Gastroenterol Res Pract 2018; Jan 31; 2018: 3805173.
• 19 Renno A. Antireflux valve metal stent versus conventional self-expandable metal stent in distal malignant biliary obstruction: a systematic review and meta-analysis. Ann Gastroenterol 2019; 32: 605-613
• 20 Kin T, Ishii K, Okabe Y. et al. Feasibility of biliary stenting to distal malignant biliary obstruction using a novel designed metal stent with duckbill‐shaped anti‐reflux valve. Digestive Endoscopy 2020; 33: 648-655
• 21 Yamada Y, Sasaki T, Takeda T. et al. A novel laser‐cut fully covered metal stent with anti‐reflux valve in patients with malignant distal biliary obstruction refractory to conventional covered metal stent. J Hepatobiliary Pancreat Sci 2021; 28: 563-571
• 22 Isayama H, Hamada T, Yasuda I. et al. TOKYO criteria 2014 for transpapillary biliary stenting: Reporting system of biliary stenting. Digestive Endoscopy 2015; 27: 259-264
• 23 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
• 24 Hamada T, Isayama H, Nakai Y. et al. Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial. Digestive Endoscopy 2019; 31: 566-574
• 25 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
• 26 Artifon ELA, Sakai P, Ishioka S. et al. Endoscopic sphincterotomy before deployment of covered metal stent is associated with greater complication rate: a prospective randomized control trial. J Clin Gastroenterol 2008; 42: 815-819
• 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
• 28 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: Migration in covered metallic stent. J Gastroenterol Hepatol 2014; 29: 1744-1749