| International Session (Workshop) 2 (JGES・JSGE・JSGS) |
| Sat. November 3rd 14:40 - 17:00 Room 13: Kobe International Conference Center International Conference Room |
| Efficacy of a the paclitaxel-eluting biliary metal stent incorporated with sodium caprate versus a covered metal stent in malignant biliary obstruction : a prospective randomized comparative study | |||
| Sung Ill Jang1, Dong Ki Lee1 | |||
| 1Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine | |||
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| Background and study aims: The placement of a self-expandable metallic stent (SEMS) is widely used nonsurgical treatment method in patients with unresectable malignant biliary obstructions but SEMS is susceptible to occlusion by tumor ingrowth or overgrowth. The efficacy and safety of a new generation paclitaxel-eluting biliary metallic stent incorporated with sodium caprate (MSCPM-III) was compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. Patients and methods: Patients with unresectable distal malignant biliary obstructions (n = 106) were prospectively enrolled in this study at multiple treatment centers. Patients underwent systemic chemotherapy regimens alternatively according to disease characteristics. Results: The two groups did not differ significantly in basic characteristics or mean follow-up period. Stent occlusion occurred in 14 patients who received MSCPM-III and in 11 patients who received CMS. Stent patency and survival time did not differ significantly between the two groups (p = 0.114, 0.407). However tumor size at 2 months after stent insertion was significantly decreased in MSCPM-III group with bile duct cancers and stent migration than CMS group. Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. Conclusions: Although the use of MSCPM-III produced no significant differences in stent patency or patient survival in patients with malignant biliary obstructions compared with the CMS, this study demonstrated that MSCPM-III has an efficacy of local tumor control and can be used safely in humans. |
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Index Term 1: Drug-eluting stent Index Term 2: malignant biliary obstruction |
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