Comparing the 14-mm uncovered and 10-mm covered metal stents in patients with distal biliary obstruction caused by unresectable pancreatic cancer: a multicenter retrospective study.
Biliary drainage
Large diameter stent
Malignant biliary obstruction
Metal stent
Pancreatic cancer
Journal
Surgical endoscopy
ISSN: 1432-2218
Titre abrégé: Surg Endosc
Pays: Germany
ID NLM: 8806653
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
29
09
2020
accepted:
27
01
2021
pubmed:
17
2
2021
medline:
3
3
2022
entrez:
16
2
2021
Statut:
ppublish
Résumé
Endoscopic biliary drainage using metal stent (MSs) is an established palliative treatment for patients with unresectable malignant distal biliary obstruction (MDBO). However, a major drawback of MS is recurrent biliary obstruction (RBO). Uncovered MSs with a diameter of 14 mm (UMS-14) were developed to overcome this. We aimed to compare the clinical outcomes of UMS-14 with those of conventional covered MSs having a diameter of 10 mm (CMS-10). Consecutive patients with MDBO caused by unresectable pancreatic cancer, who underwent UMS-14 or CMS-10 placement at two tertiary-care centers, were retrospectively examined according to the Tokyo Criteria 2014. Two hundred and thirty-eight patients who underwent UMS-14 (the UMS-14 group, n = 80) or CMS-10 (the CMS-10 group, n = 158) over a 62-month period were included. The technical and clinical success rates were similar between the two groups. RBO occurred in 20 (25%) and 59 (37%) patients of the UMS-14 and CMS-10 groups, respectively (p = 0.06). Median time till RBO was significantly longer in the UMS-14 group than in the CMS-10 group (not reached vs. 290 days, p = 0.04). Multivariate analysis revealed that CMS-10 placement was an independent risk factor for RBO (hazard ratio: 1.66, 95% confidence interval: 1.00-2.76). The incidence of early complications, including pancreatitis, and the overall survival (UMS-14 vs. CMS-10: 169 vs. 167 days, p = 0.83) were comparable between the two groups. UMS-14 stents were safe and effective for treating patients with MDBO secondary to unresectable pancreatic cancer. The insertion of UMS-14 is recommended, because it is less likely to get occluded as compared to CMS-10.
Sections du résumé
BACKGROUND
Endoscopic biliary drainage using metal stent (MSs) is an established palliative treatment for patients with unresectable malignant distal biliary obstruction (MDBO). However, a major drawback of MS is recurrent biliary obstruction (RBO). Uncovered MSs with a diameter of 14 mm (UMS-14) were developed to overcome this. We aimed to compare the clinical outcomes of UMS-14 with those of conventional covered MSs having a diameter of 10 mm (CMS-10).
METHODS
Consecutive patients with MDBO caused by unresectable pancreatic cancer, who underwent UMS-14 or CMS-10 placement at two tertiary-care centers, were retrospectively examined according to the Tokyo Criteria 2014.
RESULTS
Two hundred and thirty-eight patients who underwent UMS-14 (the UMS-14 group, n = 80) or CMS-10 (the CMS-10 group, n = 158) over a 62-month period were included. The technical and clinical success rates were similar between the two groups. RBO occurred in 20 (25%) and 59 (37%) patients of the UMS-14 and CMS-10 groups, respectively (p = 0.06). Median time till RBO was significantly longer in the UMS-14 group than in the CMS-10 group (not reached vs. 290 days, p = 0.04). Multivariate analysis revealed that CMS-10 placement was an independent risk factor for RBO (hazard ratio: 1.66, 95% confidence interval: 1.00-2.76). The incidence of early complications, including pancreatitis, and the overall survival (UMS-14 vs. CMS-10: 169 vs. 167 days, p = 0.83) were comparable between the two groups.
CONCLUSIONS
UMS-14 stents were safe and effective for treating patients with MDBO secondary to unresectable pancreatic cancer. The insertion of UMS-14 is recommended, because it is less likely to get occluded as compared to CMS-10.
Identifiants
pubmed: 33591450
doi: 10.1007/s00464-021-08342-z
pii: 10.1007/s00464-021-08342-z
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
736-744Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.
Références
Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Devière J, García-Cano J, Gyökeres T, Hassan C, Prat F, Siersema PD, van Hooft JE (2018) Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline: updated October 2017. Endoscopy 50:910–930
doi: 10.1055/a-0659-9864
Abraham NS, Barkun JS, Barkun AN (2002) Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life. Gastrointest Endosc 56:835–841
doi: 10.1016/S0016-5107(02)70356-8
Artifon EL, Sakai P, Cunha JE, Dupont A, Filho FM, Hondo FY, Ishioka S, Raju GS (2006) Surgery or endoscopy for palliation of biliary obstruction due to metastatic pancreatic cancer. Am J Gastroenterol 101:2031–2037
doi: 10.1111/j.1572-0241.2006.00764.x
GBD (2017) Pancreatic Cancer Collaborators (2019) The global, regional, and national burden of pancreatic cancer and its attributable risk factors in 195 countries and territories, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet Gastroenterol Hepatol 4:934–947
Zorrón PuL, de Moura EG, Bernardo WM, Baracat FI, Mendonça EQ, Kondo A, Luz GO, Furuya Júnior CK, Artifon EL (2015) Endoscopic stenting for inoperable malignant biliary obstruction: a systematic review and meta-analysis. World J Gastroenterol 21:13374–13385
doi: 10.3748/wjg.v21.i47.13374
Sawas T, Al Halabi S, Parsi MA, Vargo JJ (2015) Self-expandable metal stents versus plastic stents for malignant biliary obstruction: a meta-analysis. Gastrointest Endosc 82:256–267
doi: 10.1016/j.gie.2015.03.1980
Okusaka T, Nakamura M, Yoshida M, Kitano M, Uesaka K, Ito Y, Furuse J, Hanada K, Okazaki K, Committee for Revision of Clinical Guidelines for Pancreatic Cancer of the Japan Pancreas Society (2020) Clinical practice guidelines for pancreatic cancer 2019 from the Japan pancreas society: a synopsis. Pancreas 49:326–335
doi: 10.1097/MPA.0000000000001513
Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, Nakai Y, Yamamoto N, Tada M, Yoshida H, Shiratori Y, Kawabe T, Omata M (2004) A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 53:729–734
doi: 10.1136/gut.2003.018945
Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, Nishiyama O, Uehara H, Mitoro A, Sanuki T, Takaoka M, Koshitani T, Arisaka Y, Shiba M, Hoki N, Sato H, Sasaki Y, Sato M, Hasegawa K, Kawabata H, Okabe Y, Mukai H (2013) 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 108:1713–1722
doi: 10.1038/ajg.2013.305
Lee HW, Moon JH, Lee YN, Lee TH, Choi MH, Cha SW, Cho YD, Park SH (2019) Usefulness of newly modified fully covered metallic stent of 12 mm in diameter and anti-migration feature for periampullary malignant biliary strictures: comparison with conventional standard metal stent. J Gastroenterol Hepatol 34:1208–1213
doi: 10.1111/jgh.14602
Conio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A (2018) Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc 88:283-291.e3
doi: 10.1016/j.gie.2018.03.029
Kogure K, Ryozawa S, Maetani I, Nakai Y, Kawakami H, Yasuda I, Mochizuki H, Iwano H, Maguchi H, Kida M, Kubota K, Mukai T, Hasebe O, Igarashi Y, Hanada K, Irisawa A, Ito K, Itoi T, Isayama H (2018) A prospective multicenter study of a fully covered metal stent in patients with distal malignant biliary obstruction: WATCH-2 study. Dig Dis Sci 63:2466–2473
doi: 10.1007/s10620-017-4875-5
Kullman E, Frozanpor F, Söderlund C, Linder S, Sandström P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gözen M, Eriksson O (2010) Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc 72:915–923
doi: 10.1016/j.gie.2010.07.036
Kawashima H, Hashimoto S, Ohno E, Ishikawa T, Morishima T, Matsubara H, Sugimoto H, Nonogaki K, Kanamori A, Hara K, Kuwahara T, Nakamura M, Miyahara R, Ishigami M, Ando M, Hirooka Y, Nagoya Biliary Stent Study (NABIS)-01 Group (2019) Comparison of 8- and 10-mm diameter fully covered self-expandable metal stents: a multicenter prospective study in patients with distal malignant biliary obstruction. Dig Endosc 31:439–447
doi: 10.1111/den.13366
Isayama H, Kawakubo K, Nakai Y, Inoue K, Gon C, Matsubara S, Kogure H, Ito Y, Tsujino T, Mizuno S, Hamada T, Uchino R, Miyabayashi K, Yamamoto K, Sasaki T, Yamamoto N, Hirano K, Sasahira N, Tada M, Koike K (2013) A novel, fully covered laser-cut nitinol stent with antimigration properties for nonresectable distal malignant biliary obstruction: a multicenter feasibility study. Gut Liver 7:725–730
doi: 10.5009/gnl.2013.7.6.725
Ung KA, Stotzer PO, Nilsson A, Gustavsson ML, Johnsson E (2013) Covered and uncovered self-expandable metallic Hanarostents are equally efficacious in the drainage of extrahepatic malignant strictures. Results of a double-blind randomized study. Scand J Gastroenterol 48:459–465
doi: 10.3109/00365521.2012.758766
Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC, Saltzman JR, Thompson CC, Forcione DG, Gostout CJ, Brugge WR (2010) A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc 72:907–914
doi: 10.1016/j.gie.2010.08.021
Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM (2009) 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 70:445–453
doi: 10.1016/j.gie.2008.11.018
Weston BR, Ross WA, Liu J, Lee JH (2010) Clinical outcomes of nitinol and stainless steel uncovered metal stents for malignant biliary strictures: is there a difference? Gastrointest Endosc 72:1195–1200
doi: 10.1016/j.gie.2010.08.035
Chen MY, Lin JW, Zhu HP, Zhang B, Jiang GY, Yan PJ, Cai XJ (2016) Covered stents versus uncovered stents for unresectable malignant biliary strictures: a meta-analysis. Biomed Res Int 2016:6408067
pubmed: 27051667
pmcid: 4802019
Li J, Li T, Sun P, Yu Q, Wang K, Chang W, Song Z, Zheng Q (2016) Covered versus uncovered self-expandable metal stents for managing malignant distal biliary obstruction: a meta-analysis. PLoS ONE 11:e0149066
doi: 10.1371/journal.pone.0149066
Alastal Y, Hammad TA, Khan MA, Khalil BW, Khan S, Ismail MK, Nawras A, Sofi A (2015) Risk of post-ERCP pancreatitis after placement of covered versus uncovered self-expandable biliary metal stents: a systematic review and meta-analysis. JOP 16:452–458
Yang Z, Wu Q, Wang F, Ye X, Qi X, Fan D (2013) A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract. Int J Med Sci 10:825–835
doi: 10.7150/ijms.5969
Almadi MA, Barkun AN, Martel M (2013) No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol 11:27-37.e1
doi: 10.1016/j.cgh.2012.10.019
ASGE Technology Assessment Committee, Pfau PR, Pleskow DK, Banerjee S, Barth BA, Bhat YM, Desilets DJ, Gottlieb KT, Maple JT, Siddiqui UD, Tokar JL, Wang A, Song LM, Rodriguez SA (2013) Pancreatic and biliary stents. Gastrointest Endosc 77:319–327
doi: 10.1016/j.gie.2012.09.026
Kikuyama M, Shirane N, Kawaguchi S, Terada S, Mukai T, Sugimoto K (2018) New 14-mm diameter Niti-S biliary uncovered metal stent for unresectable distal biliary malignant obstruction. World J Gastrointest Endosc 10:16–22
doi: 10.4253/wjge.v10.i1.16
Mayumi T, Okamoto K, Takada T, Strasberg SM, Solomkin JS, Schlossberg D, Pitt HA, Yoshida M, Gomi H, Miura F, Garden OJ, Kiriyama S, Yokoe M, Endo I, Asbun HJ, Iwashita Y, Hibi T, Umezawa A, Suzuki K, Itoi T, Hata J, Han HS, Hwang TL, Dervenis C, Asai K, Mori Y, Huang WS, Belli G, Mukai S, Jagannath P, Cherqui D, Kozaka K, Baron TH, de Santibañes E, Higuchi R, Wada K, Gouma DJ, Deziel DJ, Liau KH, Wakabayashi G, Padbury R, Jonas E, Supe AN, Singh H, Gabata T, Chan ACW, Lau WY, Fan ST, Chen MF, Ker CG, Yoon YS, Choi IS, Kim MH, Yoon DS, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M (2018) Tokyo guidelines 2018: management bundles for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci 25:96–100
doi: 10.1002/jhbp.519
Isayama H, Hamada T, Yasuda I, Itoi T, Ryozawa S, Nakai Y, Kogure H, Koike K (2015) TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 27:259–264
doi: 10.1111/den.12379
Mukai T, Yasuda I, Isayama H, Iwashita T, Itoi T, Kawakami H, Kogure H, Nakai Y (2016) Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies. Dig Endosc 28:671–679
doi: 10.1111/den.12643
Nakaoka K, Hashimoto S, Kwabe N, Nakano T, Kan T, Ohki M, Ochi Y, Takamura T, Kurashita T, Nomura S, Koyama K, Fukui A, Yoshioka K (2018) Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction. Endosc Int Open 6:E1164–E1170
doi: 10.1055/a-0627-7078