Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Early complications
研究概览
简要总结
The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.
详细描述
Cholangiocarcinoma accounts for 3% of all gastrointestinal cancers and is the second commonest primary liver cancer. However only a few patients are suitable for surgical resection and therefore endoscopic biliary drainage is the most used palliative treatment modality for malignant hilar stricture. However, whether one or two stents can benefit the patients most is still to be defined. Numerous retrospective case series reached different conclusion, till now, only one randomized trial compared the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction, nonetheless, nearly one third of the patients had Bismuth Type I stricture, and one stent is enough for drainage in this situation, therefore, the best drainage strategy for patients with Bismuth Type II or Bismuth Type III malignant hilar obstruction is unknown. The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with Bismuth Type II or III malignant hilar obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive untreated patients with biliary obstruction (Bismuth type II, III) at the hilum due to primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases. Diagnosis is based on US, CT, and MRCP.
- •Histologic or cytologic confirmation of malignancy is established by percutaneous biopsy (US- or CT-guided) or by endoscopic tissue sampling, endoscopic brushing. Or the diagnosis is based on typical features on imaging and the expected clinical outcome during follow-up.
- •All patients were considered unsuitable for resection on the basis of general medical condition and/or tumor extent.
- •Full and informed consent is obtained.
排除标准
- •Refuse to participate in this study.
- •Refuse to provide informed consent.
- •Refuse to be placed with plastic stents.
- •Physically unfit for endoscopic treatment.
结局指标
主要结局
Early complications
时间窗: 30 days within treatment
次要结局
- 30-day mortality(30 days within treatment)
- Late complications(30 days after treatment)
- Median survival(From stent insertion to the death of the patient)
- Successful drainage(One month after stent insertion)