Jang Sung Ill, Lee Se Joon, Jeong Seok, Lee Don Haeng, Kim Myung-Hwan, Yoon Hong Jin, Lee Dong Ki
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.
Gut Liver. 2017 Jul 15;11(4):567-573. doi: 10.5009/gnl16428.
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.
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.
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.
There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.
背景/目的:为提高支架通畅率、防止肿瘤长入,研发了一种用于不可切除恶性胆管梗阻的药物洗脱支架。将新一代含紫杉醇膜并使用普朗尼克混合物的金属支架(MSCPM-II)与覆盖金属支架(CMS)在恶性胆管梗阻患者中的安全性和有效性进行了前瞻性比较。
本研究最初设计为前瞻性随机试验,但由于早期闭塞发生率高而提前终止。因此,采用意向性分析方法对数据进行分析。前瞻性纳入了72例不可切除的远端恶性胆管梗阻患者。
两组患者的基本特征和平均随访时间无显著差异(MSCPM-II组194天,CMS组277天,p = 0.063)。接受MSCPM-II的患者中有14例(35%)发生支架闭塞,接受CMS的患者中有7例(21.9%)发生支架闭塞。两组间支架通畅率和生存时间无显著差异(p = 0.355和p = 0.570)。两组并发症均较轻,通过保守治疗得以缓解。
MSCPM-II组和CMS组恶性胆管梗阻患者的支架通畅率或患者生存率无显著差异。