Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial.

摘要

PURPOSE: To compare percutaneous self-expanding metal stents with conventional endoscopic polyethylene endoprostheses for treatment of malignant biliary obstruction by means of a prospective randomized clinical trial. MATERIALS AND METHODS: Patients with biliary obstruction due to inoperable primary carcinoma of the pancreas, gallbladder, or bile ducts or regional lymph node metastases were included. Evaluated outcomes included technical and therapeutic success rates, morbidity and 30-day mortality rates, hospital stay length and readmission, biliary reobstruction, and overall survival rates. Data were analyzed according to both the intention-to-treat principle and the treatment actually administered. Univariate (Kaplan-Meier method) and multivariate (Cox model) analyses were performed. RESULTS: After randomization, 28 patients were assigned to receive a percutaneous self-expanding metal stent and 26 patients to receive a 12-F endoscopic polyethylene prosthesis. The technical success rates of both implantation procedures were similar (percutaneous, 75% [21 of 28 patients]; endoscopic, 58% [15 of 26 patients]; P =.29), whereas therapeutic success was higher in the percutaneous group (71% [20 of 28 patients] vs 42% [11 of 26 patients]; P =.03). However, major complications were more common in the percutaneous group (61% [17 of 28 patients] vs 35% [nine of 26 patients]; P =.09) but did not account for differences in 30-day mortality rates (percutaneous, 36% [10 of 28 patients]; endoscopic, 42% [11 of 26 patients]; P =.83). Overall median survival was significantly higher in the percutaneous group than in the endoscopic group (3.7 vs 2.0 months; P =.02). Cox regression analysis enabled identification of placement of the percutaneous self-expanding metal stent as the only independent predictor of survival (relative risk, 2.19; 95% CI: 1.11, 4.31; P =.02). CONCLUSION: Placement of a percutaneous self-expanding metal stent is an alternative to placement of an endoscopic polyethylene endoprosthesis in patients with malignant biliary obstruction.