NCT01774019已完成不适用
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 19
- 主要终点
- Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last
研究概览
简要总结
The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- •Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
- •Biliary obstructive symptoms or signs
- •Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
- •Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
- •Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
- •Patients deemed as resectable by pancreatic protocol CT or MRI
- •Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion
- •Surgery intent within 4 weeks
- •Endoscopic and surgical treatment to be provided by same team
排除标准
- •Biliary strictures caused by confirmed benign tumors
- •Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
- •Surgically altered biliary tract anatomy, not including prior cholecystectomy
- •Neoadjuvant chemotherapy for current malignancy
- •Palliative indication due to reasons other than surgical candidate status
- •Previous biliary drainage by ERCP/PTC
- •Patients for whom endoscopic techniques are contraindicated
- •Participation in another investigational trial within 90 days
- •Pregnancy
结局指标
主要结局
Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last
时间窗: 120 to 150 days
The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later.
次要结局
- Number of Patients With Biliary Re-interventions(120 to 150 days)
- Stent Placement Success(Procedure)
- All-cause Mortality(150 days)
- Success Rate of Curative Intent Surgery(4 weeks)
研究者
研究点 (19)
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