Fully covered metal stents as a risk factor for acute cholecystitis and cholangitis in patients with biliary stricture: A multicenter retrospective study

Aims This study examines the incidence and risk factors for acute cholecystitis and cholangitis in patients with malignant biliary strictures undergoing endoscopic retrograde cholangiopancreatography (ERCP) with fully covered metallic stent (FCMS) placement. We aimed to assess whether FCMS placement increases the risk of these complications

Methods In this retrospective, multi-center study, 338 patients from Galilee Medical Center and other hospitals who received FCMS placement for malignant biliary strictures were analyzed. Data on demographics, clinical characteristics, and complications were collected. Logistic regression identified variables associated with cholecystitis and cholangitis, including demographic factors, presence of gallbladder (GB) stones, common bile duct (CBD) stones, CBD diameter, and stent length. Sphincterotomy rates were also compared across stent lengths, and time intervals from stent insertion to follow-up were assessed to gauge monitoring needs

Results Shorter stents (40–60 mm) were associated with a significantly higher cholecystitis incidence (9.5%) compared to the 70–100 mm group (0%) (p=0.010). Cholangitis incidence showed a non-significant trend toward higher rates in the 70–100 mm group (18.5%) compared to the 40–60 mm group (10.6%) (p=0.082). Independent predictors of cholecystitis and cholangitis included GB stones (p=0.013 for cholecystitis; p<0.001 for cholangitis) and CBD stones (p=0.004 for cholangitis). A narrower CBD diameter (mean 11.65 mm in patients with cholecystitis vs. 12.98 mm in those without, p=0.011) was associated with higher cholecystitis risk. Sphincterotomy was more frequent in patients with shorter stents (83.8% in the 40–60 mm group vs. 69.2% in the 70–100 mm group, p=0.007). Patients with cholecystitis or cholangitis had significantly longer follow-up intervals (321 days and 460.3 days, respectively)

Conclusions FCMS placement, especially with shorter stents, is associated with an elevated cholecystitis risk, particularly in patients with GB stones and narrower CBD diameters. Although FCMS does not universally increase cholangitis risk, outcomes appear influenced by stent length, CBD characteristics, and procedural choices like sphincterotomy. These findings provide valuable guidance for clinicians to optimize FCMS use in patients with malignant biliary strictures, emphasizing the importance of personalized stent selection and extended monitoring for high-risk individuals [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24].

Publication History

Article published online:
27 March 2025

• References

• 1 Park D.H.. et al. Covered versus uncovered wallstent for malignant extrahepatic biliary obstruction: a cohort comparative analysis. Clin Gastroenterol Hepatol 2006; 4 (06) p 790-6
• 2 Nakai Y.. et al. Efficacy and safety of the covered Wallstent in patients with distal malignant biliary obstruction. Gastrointest Endosc 2005; 62 (05) p 742-8
• 3 Deviere J.. et al. Successful management of benign biliary strictures with fully covered self-expanding metal stents Gastroenterology. 2014; 147 (2) p385-95 quiz e15.
• 4 Saxena P.. et al. A US Multicenter Study of Safety and Efficacy of Fully Covered Self-Expandable Metallic Stents in Benign Extrahepatic Biliary Strictures. Dig Dis Sci 2015; 60 (11) p 3442-8
• 5 Almadi M.A., Barkun A.N., 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 (01) p 27-37 e1
• 6 Fumex F.. et al. Similar performance but higher cholecystitis rate with covered biliary stents: results from a prospective multicenter evaluation. Endoscopy 2006; 38 (08) p 787-92
• 7 Yoon W.J.. et al. A comparison of covered and uncovered Wallstents for the management of distal malignant biliary obstruction. Gastrointest Endosc 2006; 63 (07) p 996-1000
• 8 Saleem A.. et al. Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation of distal malignant bile duct obstruction. Gastrointest Endosc 2011; 74 (2) p. 321-327 e1-3
• 9 Isayama H.. et al. Results of a Japanese multicenter, randomized trial of endoscopic stenting for non-resectable pancreatic head cancer (JM-test): Covered Wallstent versus DoubleLayer stent. Dig Endosc 2011; 23 (04) p 310-5
• 10 Kaassis M.. et al. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc 2003; 57 (02) p 178-82
• 11 Watanabe M, Okuwaki K, Woo J, Kida M, Imaizumi H, Iwai T, Yamauchi H, Kaneko T, Hasegawa R, Kurosu T, Minato N, Haradome H, Koizumi W.. Cholecystitis after Placement of Covered Self-Expandable Metallic Stents in Patients with Distal Malignant Biliary Obstructions. Clin Endosc 2021; 54 (04): 589-595
• 12 Jang S, Stevens T, Parsi M, Lopez R, Zuccaro G, Dumot J, Vargo JJ.. Association of covered metallic stents with cholecystitis and stent migration in malignant biliary stricture. Gastrointest Endosc 2018; 87 (04): 1061-1070 Epub 2017 Sep 1. PMID: 28867074
• 13 Takinami M, Murohisa G, Yoshizawa Y, Shimizu E, Nagasawa M.. Risk factors for cholecystitis after stent placement in patients with distal malignant biliary obstruction. J Hepatobiliary Pancreat. Sci. 2020; 27 (08): 470-476 Epub 2020 Jun 21. PMID: 32462813
• 14 Kim GH, Ryoo SK, Park JK, Park JK, Lee KH, Lee KT, Lee JK.. Risk Factors for Pancreatitis and Cholecystitis after Endoscopic Biliary Stenting in Patients with Malignant Extrahepatic Bile Duct Obstruction. Clin Endosc 2019; 52 (06): 598-605 Epub 2019 May 28. PMID: 31132847; PMCID: PMC6900294
• 15 Nakai Y, Isayama H, Kawakubo K, Kogure H, Hamada T, Togawa O, Ito Y, Matsubara S, Arizumi T, Yagioka H, Takahara N, Uchino R, Mizuno S, Miyabayashi K, Yamamoto K, Sasaki T, Yamamoto N, Hirano K, Tada M, Koike K.. Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction. J Gastroenterol Hepatol 2014; 29 (07): 1557-62 PMID: 24628054. 24628054
• 16 Isayama H, Kawabe T, Nakai Y, Tsujino T, Sasahira N, Yamamoto N, Arizumi T, Togawa O, Matsubara S, Ito Y, Sasaki T, Hirano K, Toda N, Komatsu Y, Tada M, Yoshida H, Omata M.. Cholecystitis after metallic stent placement in patients with malignant distal biliary obstruction. Clin Gastroenterol Hepatol 2006; 4 (09): 1148-53 Epub 2006 Aug 14. PMID: 16904950
• 17 Suk KT, Kim HS, Kim JW, Baik SK, Kwon SO, Kim HG, Lee DH, Yoo BM, Kim JH, Moon YS, Lee DK.. Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction. Gastrointest Endosc 2006; 64 (04): 522-9 PMID: 16996343
• 18 Schoder M.. et al. Malignant biliary obstruction: treatment with ePTFE-FEP- covered endoprostheses initial technical and clinical experiences in a multicenter trial. Radiology 2002; 225 (01) p 35-42
• 19 Bezzi M.. et al. New ePTFE/FEP-covered stent in the palliative treatment of malignant biliary obstruction. J Vasc Interv Radiol 2002; 13 (06) p 581-9
• 20 Isayama H.. et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53 (05) p 729-34
• 21 Kahaleh M.. et al. Efficacy and complications of covered Wallstents in malignant distal biliary obstruction. Gastrointest Endosc 2005; 61 (04) p 528-33
• 22 Davids P.H.. et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992; 340 8834/8835 p 1488-92
• 23 Artifon E.L.. et al. Surgery or endoscopy for palliation of biliary obstructthesis...e to metastatic pancreatic cancer. Am J Gastroenterol 2006; 101 (09) p 2031-7
• 24 Andersen J.R.. et al. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Gut 1989; 30 (08) p 1132-5