Gut Liver.
2017 Jul;11(4):567-573. 10.5009/gnl16428.
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
- Affiliations
-
- 1Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 2Department of Medicine, The Graduate School of Yonsei University, Yonsei University College of Medicine, Seoul, Korea.
- 3Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. dklee@yuhs.ac
- 4Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea.
- 5Utah-Inha Drug Delivery System & Advanced Therapeutics Research Center, Incheon, Korea.
- 6Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- KMID: 2412238
- DOI: http://doi.org/10.5009/gnl16428
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 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.
Keyword
MeSH Terms
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Aged
Antineoplastic Agents, Phytogenic/*administration & dosage
Bile Duct Neoplasms/complications/*drug therapy
Cholestasis/drug therapy/etiology/*surgery
*Drug-Eluting Stents
Early Termination of Clinical Trials
Female
Humans
Male
Metals
Middle Aged
Paclitaxel/*administration & dosage
Poloxamer/therapeutic use
Prospective Studies
Surface-Active Agents/therapeutic use
Treatment Outcome
Antineoplastic Agents, Phytogenic
Metals
Surface-Active Agents
Poloxamer
Paclitaxel
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