A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer. - "Covered" vs "uncovered" metallic stents for biliary stricture by unresectable pancreatic cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
Patient survival time in the two groups did not signifi cantly differ (median: 285 and 223 days, respectively; P = 0.68). Patient survival time without stent dysfunction was signifi cantly longer in the covered than in the uncovered SEMS group (median: 187 vs. 132 days; P = 0.043).Stent patency was also signifi cantly longer in the covered than in the uncovered SEMS group (mean +- s.d.: 219.3 +- 159.1 vs. 166.9 +- 124.9 days; P = 0.047).Rates of tumor overgrowth and sludge formation did not signifi cantly differ between the two groups, whereas the rate of tumor ingrowth was signifi cantly lower in the covered than in the uncovered SEMS group ( P < 0.01).There was no signifi cant difference between the two groups in the incidence of serious adverse events.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) PS > 4. 2) Severe complication of another organ. 3) A patient who gives no written IC. 4) A participating doctor thinks the patient is not proper for this study. 5) Prognosis will be within 3 months. 6) Initial drainage worsen the status of the patient.