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.
OBJECTIVE
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 follow-up 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.
Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.|Department of Medicine, The Graduate School of Yonsei University, Yonsei University College of Medicine, Seoul, Korea.
Sung Ill
SI
Jang
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Se Joon
SJ
Lee
Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea.
Seok
S
Jeong
Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea.|Utah-Inha Drug Delivery System & Advanced Therapeutics Research Center, Incheon, Korea.
Don Haeng
DH
Lee
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Myung-Hwan
MH
Kim
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Hong Jin
HJ
Yoon
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Dong Ki
DK
Lee
D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D001650:Bile Duct Neoplasms / Q000150:complications / Q000188:drug therapy*; D002779:Cholestasis / Q000188:drug therapy / Q000209:etiology / Q000601:surgery*; D054855:Drug-Eluting Stents; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D020442:Poloxamer / Q000627:therapeutic use; D011446:Prospective Studies; D013501:Surface-Active Agents / Q000627:therapeutic use; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D008670:Metals; D013501:Surface-Active Agents; D020442:Poloxamer; D017239:Paclitaxel
Biliary tract neoplasms; Drug-eluting stents; Pancreatic neoplasms; Self expandable metallic stents