본문 바로가기
KERD
논문KCI 등재

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study

1

조회

0

다운로드

6

인용

0

참고문헌

키워드

초록

Background/Aims: A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. Methods: This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. Results: The two groups did not differ significantly in basic characteristics and mean followup period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. Conclusions: There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Abstract

Background/Aims: A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. Methods: This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. Results: The two groups did not differ significantly in basic characteristics and mean followup period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. Conclusions: There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

참고문헌 (29)

  1. Smith AC, "Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction", Lancet, 344, pp.1655~1660 (1994)
  2. Andersen JR, "Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice", Gut, 30, pp.1132~1135 (1989)
  3. Larssen L, "Long-term outcome of palliative treatment with self-expanding metal stents for malignant obstructions of the GI tract", Scand J Gastroenterol, 47, pp.1505~1514 (2012)
  4. Wagner HJ, "Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction: a prospective and randomized trial", Endoscopy, 25, pp.213~218 (1993)
  5. O’Brien S, "A three year follow up of self expanding metal stents in the endoscopic palliation of longterm survivors with malignant biliary obstruction", Gut, 36, pp.618~621 (1995)
  6. Knyrim K, "A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct", Endoscopy, 25, pp.207~212 (1993)
  7. Ung KA, "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, pp.459~465 (2013)
  8. Hausegger KA, "Malignant biliary obstruction: histologic findings after treatment with self-expandable stents", Radiology, 185, pp.461~464 (1992)
  9. Kim HS, "Features of malignant biliary obstruction affecting the patency of metallic stents: a multicenter study", Gastrointest Endosc, 55, pp.359~365 (2002)
  10. Yang MJ, "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, 50, pp.1490~1499 (2015)
  11. Lee DK, "The effect on porcine bile duct of a metallic stent covered with a paclitaxel-incorporated membrane", Gastrointest Endosc, 61, pp.296~301 (2005)
  12. Suk KT, "Human application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction: multicenter pilot study", Gastrointest Endosc, 66, pp.798~803 (2007)
  13. Lee DK, "Drug-eluting stent in malignant biliary obstruction", J Hepatobiliary Pancreat Surg, 16, pp.628~632 (2009)
  14. Lee SS, "Histologic influence of paclitaxeleluting covered metallic stents in a canine biliary model", Gastrointest Endosc, 69, pp.1140~1147 (2009)
  15. Song TJ, "Paclitaxel-eluting covered metal stents versus covered metal stents for distal malignant biliary obstruction: a prospective comparative pilot study", Gastrointest Endosc, 73, pp.727~733 (2011)
  16. Chung MJ, "Safety evaluation of self-expanding metallic biliary stents eluting gemcitabine in a porcine model", J Gastroenterol Hepatol, 27, pp.261~267 (2012)
  17. Jang SI, "Efficacy of a metallic stent covered with a paclitaxel-incorporated membrane versus a covered metal stent for malignant biliary obstruction: a prospective comparative study", Dig Dis Sci, 58, pp.865~871 (2013)
  18. Jang SI, "Porcine feasibility and safety study of a new paclitaxel-eluting biliary stent with a Pluronic-containing membrane.", Endoscopy, 44, pp.825~831 (2012)
  19. Isayama H, "TOKYO criteria 2014 for transpapillary biliary stenting", Dig Endosc, 27, pp.259~264 (2015)
  20. Khan I, "Analysis and evaluation of a biomedical polycarbonate urethane tested in an in vitro study and an ovine arthroplasty model. Part II: in vivo investigation", Biomaterials, 26, pp.633~643 (2005)
  21. Hausegger KA, "Treatment of malignant biliary obstruction with polyurethane-covered Wallstents", AJR Am J Roentgenol, 170, pp.403~408 (1998)
  22. Kim JH, "Membrane degradation of covered stents in the upper gastrointestinal tract: frequency and clinical significance", J Vasc Interv Radiol, 19(2 Pt 1), pp.220~224 (2008)
  23. Gebhart CL, "Design and formulation of polyplexes based on pluronic-polyethyleneimine conjugates for gene transfer", Bioconjug Chem, 13, pp.937~944 (2002)
  24. Isayama H, "Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent", Surg Endosc, 24, pp.131~137 (2010)
  25. Isayama H, "Covered metallic stenting for malignant distal biliary obstruction: clinical results according to stent type", J Hepatobiliary Pancreat Sci, 18, pp.673~677 (2011)
  26. Perri V, "Prospective evaluation of the partially covered nitinol “ComVi” stent for malignant non hilar biliary obstruction", Dig Liver Dis, 45, pp.305~309 (2013)
  27. Nakai Y, "Efficacy and safety of metallic stents in patients with unresectable pancreatic cancer receiving gemcitabine", Pancreas, 37, pp.405~410 (2008)
  28. Hwang CW, "Impact of transport and drug properties on the local pharmacology of drug-eluting stents", Int J Cardiovasc Intervent, 5, pp.7~12 (2003)
  29. Jeong D, "Nonvascular drug-eluting stent coated with sodium caprate-incorporated polyurethane for the efficient penetration of paclitaxel into tumor tissue", J Biomater Appl, 29, pp.1133~1144 (2015)

관련 논문AI추천

A Double-Layered Covered Biliary Metal Stent for the Management of Unresectable Malignant Biliary Obstruction: A Multicenter Feasibility Study정석, 동석호, 문종호, 박진석, 이규택, 이돈행거트앤리버 소화기연관학회협의회 · Gut and Liver2016 · 제10권 제6호Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction고규봉, 김선주, 김재윤, 문정호, 박상흠, 이윤나, 이태훈, 정윤호, 정일권, 조영신, 차상우, 최영덕, 최현종거트앤리버 소화기연관학회협의회 · Gut and Liver2017 · 제11권 제3호A Comparative Study on the Efficacy of Covered Metal Stent and Plastic Stent in Unresectable Malignant Biliary Obstruction고광현, 김진홍, 박상흠, 유교상, 유병무, 유준환, 최재명, 황재철, Do Hyun Park, Dong Ki Lee, Ho Gak Kim, Soon Sun Kim대한소화기내시경학회 · Clinical Endoscopy2012 · 제45권 제1호A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective studyArata Sakai, Atsuhiro Masuda, Daisuke Shirasaka, Hideyuki Shiomi, Ikuya Miki, Keisuke Furumatsu, Kodai Yamanaka, Saori Kakuyama, Shiei Yoshida, Shinya Kohashi, Takaaki Eguchi, Takao Iemoto, Takashi Kobayashi, Yoshihiro Okabe, Yosuke Yagi, Yuzo Kodama대한소화기내시경학회 · Clinical Endoscopy2024 · 제57권 제3호Efficacy of multi-hole self-expandable metallic stents versus partially covered self-expandable metallic stents in patients with malignant distal biliary obstruction caused by unresectable pancreatic cancer: a retrospective comparative cohort study in JapanAkira Mitoro, Fumimasa Tomooka, Hitoshi Yoshiji, Jun-ichi Hanatani, Koh Kitagawa, Kosuke Kaji, Shohei Asada, Tomihiro Iwata, Yui Osaki, Yuki Motokawa대한소화기내시경학회 · Clinical Endoscopy2025 · 제58권 제5호A Novel, Fully Covered Laser-Cut Nitinol Stent with Antimigration Properties for Nonresectable Distal Malignant Biliary Obstruction: A Multicenter Feasibility StudyChimyon Gon, Hirofum Kogure, Hiroyuki Isayama, Kazuhiko Koike, Kazumichi Kawakubo, Keisuke Yamamoto, Kenji Hirano, Koji Miyabayashi, Kouta Inoue, Minoru Tada, Naoki Sasahira, Natsuyo Yamamoto, Rie Uchino, Saburo Matsubara, Suguru Mizuno, Takashi Sasaki, Takeshi Tsujino, Tsuyoshi Hamada, Yousuke Nakai, Yukiko Ito거트앤리버 소화기연관학회협의회 · Gut and Liver2013 · 제7권 제6호

이 간행물의 다른 논문 (17건)