CTRI/2015/01/005437进行中（未招募）4 期
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 294
- 试验地点
- 1
- 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
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 μmol 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 2 cm 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 days
次要结局
- Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques(Baseline to 4 weeks)
- Number of adverse events. Adverse events will be assessed in terms of rate, severity, seriousness, relatedness to stent or endoscopic or surgical procedure, impact on time of surgery, length of hospitalization and ICU stay(Procedure - 120 days)
- Time to surgery(Baseline to 4 weeks)
- Amount of intraoperative blood loss and blood transfusions, duration of surgery(At time of surgery)
- Biliary obstructive symptoms assessment(Baseline - 120 days)
- Improvement of liver function test (LFT) levels as relative to baseline(Week 2 - 120 days)
- Stent placement success: ability to deploy the stent in satisfactory position across the stricture (For patients who are randomized to biliary drainage with a metal stent)(Procedure)
- Stent removal success: successful SEMS removal, either en bloc at time of surgery or endoscopically prior to surgery without stent removal related SAEs (For patients who are randomized to biliary drainage with a metal stent)(At time of surgery or prior to surgery if re-intervention is needed)
- Number, type, reason, and timing of biliary re-interventions(Baseline - 120 days)
- Number of hospital and ICU admissions(Procedure - 120 days)
- Duration of hospital and ICU admissions(Procedure - 120 days)
研究者
研究点 (1)
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