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.
| Original language | English |
|---|---|
| Pages (from-to) | 567-573 |
| Number of pages | 7 |
| Journal | Gut and liver |
| Volume | 11 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 2017 Jul |
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All Science Journal Classification (ASJC) codes
- Hepatology
- Gastroenterology
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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. / Jang, Sung Ill; Lee, Se Joon; Jeong, Seok; Lee, Don Haeng; Kim, Myung Hwan; Yoon, Hong Jin; Lee, Dong Ki.
In: Gut and liver, Vol. 11, No. 4, 07.2017, p. 567-573.Research output: Contribution to journal › Article
TY - JOUR
T1 - Efficacy of a multiplex paclitaxel emission stent using a Pluronic® mixture membrane versus a covered metal stent in malignant biliary obstruction
T2 - A prospective randomized comparative study
AU - Jang, Sung Ill
AU - Lee, Se Joon
AU - Jeong, Seok
AU - Lee, Don Haeng
AU - Kim, Myung Hwan
AU - Yoon, Hong Jin
AU - Lee, Dong Ki
PY - 2017/7
Y1 - 2017/7
N2 - 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.
AB - 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=85021837067&partnerID=8YFLogxK
U2 - 10.5009/gnl16428
DO - 10.5009/gnl16428
M3 - Article
C2 - 28335102
AN - SCOPUS:85021837067
VL - 11
SP - 567
EP - 573
JO - Gut and Liver
JF - Gut and Liver
SN - 1976-2283
IS - 4
ER -