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
Gut and Liver
; : 567-573, 2017.
Article
in En
| WPRIM
| ID: wpr-88938
Responsible library:
WPRO
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.Key words
Full text:
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Index:
WPRIM
Main subject:
Pancreatic Neoplasms
/
Biliary Tract Neoplasms
/
Stents
/
Incidence
/
Prospective Studies
/
Follow-Up Studies
/
Paclitaxel
/
Drug-Eluting Stents
/
Self Expandable Metallic Stents
/
Membranes
Type of study:
Clinical_trials
/
Incidence_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
Gut and Liver
Year:
2017
Type:
Article