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)
- Smith AC, "Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction", Lancet, 344, pp.1655~1660 (1994)
- Andersen JR, "Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice", Gut, 30, pp.1132~1135 (1989)
- 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)
- 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)
- 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)
- Knyrim K, "A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct", Endoscopy, 25, pp.207~212 (1993)
- 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)
- Hausegger KA, "Malignant biliary obstruction: histologic findings after treatment with self-expandable stents", Radiology, 185, pp.461~464 (1992)
- Kim HS, "Features of malignant biliary obstruction affecting the patency of metallic stents: a multicenter study", Gastrointest Endosc, 55, pp.359~365 (2002)
- 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)
- 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)
- 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)
- Lee DK, "Drug-eluting stent in malignant biliary obstruction", J Hepatobiliary Pancreat Surg, 16, pp.628~632 (2009)
- Lee SS, "Histologic influence of paclitaxeleluting covered metallic stents in a canine biliary model", Gastrointest Endosc, 69, pp.1140~1147 (2009)
- 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)
- Chung MJ, "Safety evaluation of self-expanding metallic biliary stents eluting gemcitabine in a porcine model", J Gastroenterol Hepatol, 27, pp.261~267 (2012)
- 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)
- 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)
- Isayama H, "TOKYO criteria 2014 for transpapillary biliary stenting", Dig Endosc, 27, pp.259~264 (2015)
- 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)
- Hausegger KA, "Treatment of malignant biliary obstruction with polyurethane-covered Wallstents", AJR Am J Roentgenol, 170, pp.403~408 (1998)
- 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)
- Gebhart CL, "Design and formulation of polyplexes based on pluronic-polyethyleneimine conjugates for gene transfer", Bioconjug Chem, 13, pp.937~944 (2002)
- Isayama H, "Management of distal malignant biliary obstruction with the ComVi stent, a new covered metallic stent", Surg Endosc, 24, pp.131~137 (2010)
- 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)
- 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)
- Nakai Y, "Efficacy and safety of metallic stents in patients with unresectable pancreatic cancer receiving gemcitabine", Pancreas, 37, pp.405~410 (2008)
- 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)
- 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)
