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

Abstract

Background/AimsA 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.MethodsThis 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.ResultsThe 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.ConclusionsThere were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Multidisciplinary Approach to Malignant Biliary Obstruction

“…There was, however, no demonstrated significant increase in mean stent patency or mean survival time using these stents. 61 When SEMS are placed across the ampulla, there is an increased risk of reflux of duodenal contents including bacteria and food particles into the stent which may cause obstruction and cholangitis. 62 Antireflux SEMS (AR-SEMS) were recently developed to prevent such retrograde flow.…”

Piperlongumine-Eluting Gastrointestinal Stent Using Reactive Oxygen Species-Sensitive Nanofiber Mats for Inhibition of Cholangiocarcinoma Cells

“…However, metal stent has no curative function, and tumor-overgrowth inside stent normally induces biliary obstruction. To solve these problems, many scientists have investigated drug-eluting stent (DES) [12–15]. For example, Lee group investigated paclitaxel-eluting gastrointestinal (GI) stent in the last decade [12–15].…”

“…To solve these problems, many scientists have investigated drug-eluting stent (DES) [12–15]. For example, Lee group investigated paclitaxel-eluting gastrointestinal (GI) stent in the last decade [12–15]. Although paclitaxel-eluting stent has little differences in stent patency and patient survivability compared to a covered metal stent, they observed acceptability of paclitaxel-eluting stent in porcine feasibility and safety study [13–15].…”

“…For example, Lee group investigated paclitaxel-eluting gastrointestinal (GI) stent in the last decade [12–15]. Although paclitaxel-eluting stent has little differences in stent patency and patient survivability compared to a covered metal stent, they observed acceptability of paclitaxel-eluting stent in porcine feasibility and safety study [13–15]. Kim et al investigated DES using sorafenib, a tyrosine protein kinase inhibitor, against HuCC-T1 CCA cells using animal tumor xenograft models, and sorafenib-eluting stent has efficacies to inhibit tumor growth in animal tumor xenograft model [16].…”

Which Is Crucial, Strengthen the Foundation or Building the Dream House?

“…Naked wires are exposed on both the outer and inner surfaces of the covered SEMS used in the article written by Jang et al .,1 and we previously reported a high incidence of food impaction and sludge formation with short-term use of such stents 7. Jang, et al .…”