Uncovered Hanaro Versus Luminex metal stents for palliation of malignant biliary strictures.

摘要

BACKGROUND: Endoscopic stent insertion is the optimum method of palliation for malignant biliary obstruction. Various types of self-expanding metal stents have been introduced in the market. Whether one type of stents is superior to the others in terms of stent patency remains undefined. GOALS: This randomized trial compared 2 uncovered metal stents with similar technical characteristics, but significant cost difference, in the palliation of inoperable malignant biliary strictures. STUDY: Ninety-two patients with inoperable biliary obstruction were randomized to receive either a 10-mm diameter Hanaro or Luminex uncovered metal stent. The duration of stent patency, the overall patient survival, the mechanism of stent occlusion, and the adverse events were analyzed. RESULTS: Eighty-nine patients were included in the analysis; 44 received Hanaro stents and 45 Luminex stents. The overall median patency rates between the 2 stents did not differ (328 d for the Hanaro vs. 289 d for the Luminex stent; P=0.815). Similarly, no difference was found between the overall median survival rates by the 2 stents (347 d for the Hanaro vs. 307 d for the Luminex stent; P=0.654). Two major procedure-related complications occurred, perforation (Hanaro stent) and proximal stent migration (Luminex stent). Stent occlusion requiring reintervention occurred in 25 patients (11 with the Hanaro vs. 14 with the Luminex stent; P=0.521). CONCLUSIONS: The 2 uncovered metal stents are comparable in terms of placement, occlusion rates, overall stent patency, and patient survival; Hanaro stent insertion, however, seems to be a cost-saving strategy at least in Greece.