Clinical trial NCT06453590 - References

Bile Duct Cancer — Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents

Citation(s)

•   Cavell LK, Allen PJ, Vinoya C, Eaton AA, Gonen M, Gerdes H, Mendelsohn RB, D'Angelica MI, Kingham TP, Fong Y, Dematteo R, Jarnagin WR, Kurtz RC, Schattner MA
  Biliary self-expandable metal stents do not adversely affect pancreaticoduodenectomy. Am J Gastroenterol. 2013 Jul;108(7):1168-73. doi: 10.1038/ajg.2013.93. Epub 2013 Apr 2.
•   Chen MY, Lin JW, Zhu HP, Zhang B, Jiang GY, Yan PJ, Cai XJ
  Covered Stents versus Uncovered Stents for Unresectable Malignant Biliary Strictures: A Meta-Analysis. Biomed Res Int. 2016;2016:6408067. doi: 10.1155/2016/6408067. Epub 2016 Mar 16.
•   Cotton PB, Garrow DA, Gallagher J, Romagnuolo J
  Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc. 2009 Jul;70(1):80-8. doi: 10.1016/j.gie.2008.10.039. Epub 2009 Mar 14.
•   Gardner TB, Spangler CC, Byanova KL, Ripple GH, Rockacy MJ, Levenick JM, Smith KD, Colacchio TA, Barth RJ, Zaki BI, Tsapakos MJ, Gordon SR
  Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial. Gastrointest Endosc. 2016 Sep;84(3):460-6. doi: 10.1016/j.gie.2016.02.047. Epub 2016 Mar 10.
•   Ghazi R, AbiMansour JP, Mahmoud T, Martin JA, Law RJ, Levy MJ, Abu Dayyeh BK, Storm AC, Petersen BT, Chandrasekhara V
  Uncovered versus fully covered self-expandable metal stents for the management of distal malignant biliary obstruction. Gastrointest Endosc. 2023 Oct;98(4):577-584.e4. doi: 10.1016/j.gie.2023.05.047. Epub 2023 May 16.
•   Irisawa A, Katanuma A, Itoi T
  Otaru consensus on biliary stenting for unresectable distal malignant biliary obstruction. Dig Endosc. 2013 May;25 Suppl 2:52-7. doi: 10.1111/den.12069.
•   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
  A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant biliary obstruction. Gut. 2004 May;53(5):729-34. doi: 10.1136/gut.2003.018945.
•   Isayama H, Mukai T, Itoi T, Maetani I, Nakai Y, Kawakami H, Yasuda I, Maguchi H, Ryozawa S, Hanada K, Hasebe O, Ito K, Kawamoto H, Mochizuki H, Igarashi Y, Irisawa A, Sasaki T, Togawa O, Hara T, Kamada H, Toda N, Kogure H
  Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointest Endosc. 2012 Jul;76(1):84-92. doi: 10.1016/j.gie.2012.02.039. Epub 2012 Apr 5.
•   Itoi T, Sofuni A, Itokawa F, Tonozuka R, Ishii K
  Current status and issues regarding biliary stenting in unresectable biliary obstruction. Dig Endosc. 2013 May;25 Suppl 2:63-70. doi: 10.1111/den.12062.
•   Jang S, Stevens T, Parsi MA, Bhatt A, Kichler A, Vargo JJ
  Superiority of Self-Expandable Metallic Stents Over Plastic Stents in Treatment of Malignant Distal Biliary Strictures. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e182-e195. doi: 10.1016/j.cgh.2020.12.020. Epub 2020 Dec 18.
•   Kim HS, Lee DK, Kim HG, Park JJ, Park SH, Kim JH, Yoo BM, Roe IH, Moon YS, Myung SJ
  Features of malignant biliary obstruction affecting the patency of metallic stents: a multicenter study. Gastrointest Endosc. 2002 Mar;55(3):359-65. doi: 10.1067/mge.2002.121603.
•   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
  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 Nov;108(11):1713-22. doi: 10.1038/ajg.2013.305. Epub 2013 Sep 17.
•   Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom 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, Gozen M, Eriksson O
  Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010 Nov;72(5):915-23. doi: 10.1016/j.gie.2010.07.036.
•   Lee JH, Krishna SG, Singh A, Ladha HS, Slack RS, Ramireddy S, Raju GS, Davila M, Ross WA
  Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients. Gastrointest Endosc. 2013 Aug;78(2):312-24. doi: 10.1016/j.gie.2013.02.032. Epub 2013 Apr 13.
•   Linder S, Bostrom L, Nilsson B
  Pancreatic cancer in sweden 1980-2000: a population-based study of hospitalized patients concerning time trends in curative surgery and other interventional therapies. J Gastrointest Surg. 2006 May;10(5):672-8. doi: 10.1016/j.gassur.2005.10.005.
•   Linder S, Bostrom L, Nilsson B
  Pancreatic carcinoma incidence and survival in Sweden in 1980-2000: a population-based study of 16,758 hospitalized patients with special reference to different therapies. Eur J Surg Oncol. 2007 Jun;33(5):616-22. doi: 10.1016/j.ejso.2006.12.022. Epub 2007 Feb 20.
•   Luigiano C, Ferrara F, Cennamo V, Fabbri C, Bassi M, Ghersi S, Consolo P, Morace C, Polifemo AM, Billi P, Ceroni L, Alibrandi A, D'Imperio N
  A comparison of uncovered metal stents for the palliation of patients with malignant biliary obstruction: nitinol vs. stainless steel. Dig Liver Dis. 2012 Feb;44(2):128-33. doi: 10.1016/j.dld.2011.08.015. Epub 2011 Sep 15.
•   Moss AC, Morris E, Mac Mathuna P
  Palliative biliary stents for obstructing pancreatic carcinoma. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD004200. doi: 10.1002/14651858.CD004200.pub4.
•   Saleem A, Leggett CL, Murad MH, Baron TH
  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 Aug;74(2):321-327.e1-3. doi: 10.1016/j.gie.2011.03.1249. Epub 2011 Jun 17.
•   Saxena P, Diehl DL, Kumbhari V, Shieh F, Buscaglia JM, Sze W, Kapoor S, Komanduri S, Nasr J, Shin EJ, Singh V, Lennon AM, Kalloo AN, Khashab MA
  A US Multicenter Study of Safety and Efficacy of Fully Covered Self-Expandable Metallic Stents in Benign Extrahepatic Biliary Strictures. Dig Dis Sci. 2015 Nov;60(11):3442-8. doi: 10.1007/s10620-015-3653-5. Epub 2015 Apr 8.
•   Seaton RA, Nathwani D, Phillips G, Millar R, Davey P
  Clinical record keeping in patients receiving antibiotics in hospital. Health Bull (Edinb). 1999 Mar;57(2):128-33.
•   Soderlund C, Linder S, Bergenzaun PE, Grape T, Hakansson HO, Kilander A, Lindell G, Ljungman M, Ohlin B, Nielsen J, Rudberg C, Stotzer PO, Svartholm E, Toth E, Frozanpor F
  Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial. Endoscopy. 2014 Nov;46(11):941-8. doi: 10.1055/s-0034-1377936. Epub 2014 Oct 16.
•   Soderlund C, Linder S
  Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc. 2006 Jun;63(7):986-95. doi: 10.1016/j.gie.2005.11.052.
•   Song TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC
  Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22.
•   Suksai N, Kamalaporn P, Chirnaksorn S, Siriyotha S
  Factors associated with patency of self-expandable metal stents in malignant biliary obstruction. BMC Gastroenterol. 2023 Nov 14;23(1):392. doi: 10.1186/s12876-023-03028-3.
•   Tamura T, Yamai T, Uza N, Yamasaki T, Masuda A, Tomooka F, Maruyama H, Shigekawa M, Ogura T, Kuriyama K, Asada M, Matsumoto H, Takenaka M, Mandai K, Osaki Y, Matsumoto K, Sanuki T, Shiomi H, Yamagata Y, Doi T, Inatomi O, Nakanishi F, Emori T, Shimatani M, Asai S, Fujigaki S, Shimokawa T, Kitano M
  Adverse events of self-expandable metal stent placement for malignant distal biliary obstruction: a large multicenter study. Gastrointest Endosc. 2024 Jan;99(1):61-72.e8. doi: 10.1016/j.gie.2023.08.004. Epub 2023 Aug 19.
•   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
  A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010 Nov;72(5):907-14. doi: 10.1016/j.gie.2010.08.021.
•   Ung KA, Stotzer PO, Nilsson A, Gustavsson ML, Johnsson E
  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. 2013 Apr;48(4):459-65. doi: 10.3109/00365521.2012.758766. Epub 2013 Feb 4.
•   Vanella G, Coluccio C, Cucchetti A, Leone R, Dell'Anna G, Giuffrida P, Abbatiello C, Binda C, Fabbri C, Arcidiacono PG
  Fully covered versus partially covered self-expandable metal stents for palliation of distal malignant biliary obstruction: a systematic review and meta-analysis. Gastrointest Endosc. 2024 Mar;99(3):314-322.e19. doi: 10.1016/j.gie.2023.10.023. Epub 2023 Oct 7.
•   Walter D, van Boeckel PG, Groenen MJ, Weusten BL, Witteman BJ, Tan G, Brink MA, Nicolai J, Tan AC, Alderliesten J, Venneman NG, Laleman W, Jansen JM, Bodelier A, Wolters FL, van der Waaij LA, Breumelhof R, Peters FT, Scheffer RC, Leenders M, Hirdes MM, Steyerberg EW, Vleggaar FP, Siersema PD
  Cost Efficacy of Metal Stents for Palliation of Extrahepatic Bile Duct Obstruction in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):130-8. doi: 10.1053/j.gastro.2015.03.012. Epub 2015 Mar 17.
•   Yamao K, Takenaka M, Ogura T, Hashimoto H, Matsumoto H, Yamamoto M, Ikeura T, Kurita A, Li ZL, Shiomi H, Chiba Y, Kudo M, Sanuki T
  Utility and Safety of a Novel Fully Covered Metal Stent in Unresectable Distal Malignant Biliary Obstruction. Dig Dis Sci. 2020 Dec;65(12):3702-3709. doi: 10.1007/s10620-020-06114-8. Epub 2020 Feb 8.
•   Yamashita Y, Tachikawa A, Shimokawa T, Yamazaki H, Itonaga M, Sakai Y, Sugiyama H, Nakai Y, Tanaka K, Isayama H, Kitano M
  Covered versus uncovered metal stent for endoscopic drainage of a malignant distal biliary obstruction: Meta-analysis. Dig Endosc. 2022 Jul;34(5):938-951. doi: 10.1111/den.14260. Epub 2022 Mar 17.
•   Yang MJ, Kim JH, Yoo BM, Hwang JC, Yoo JH, Lee KS, Kang JK, Kim SS, Lim SG, Shin SJ, Cheong JY, Lee KM, Lee KJ, Cho SW
  Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial. Scand J Gastroenterol. 2015;50(12):1490-9. doi: 10.3109/00365521.2015.1057219. Epub 2015 Jul 1.
•   Zorron Pu L, de Moura EG, Bernardo WM, Baracat FI, Mendonca EQ, Kondo A, Luz GO, Furuya Junior CK, Artifon EL
  Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol. 2015 Dec 21;21(47):13374-85. doi: 10.3748/wjg.v21.i47.13374.

Palliative Treatment of Distal Malignant Biliary Obstruction by Endoscopic Stents: Uncovered, Partially Covered, or Fully Covered Metal Stents: A Prospective Randomized Multicenter Study

Details for clinical trial NCT06453590