Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Incidence of Infectious Complications After Biliary Drainage
研究概览
简要总结
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who have periampullary tumors causing obstructive jaundice
- •patient age: ≥20 and ≤85
- •resectable state of disease
- •no history of previous chemotherapy or radiotherapy
- •patients without uncontrollable severe cardiovascular, respiratory disease
- •Karnofsky performance scale ≥70
- •informed consent
排除标准
- •patients with distant metastasis or locally advanced disease with major vascular invasion
- •duodenal cancer
- •biliary drainage before randomization
- •previous chemotherapy or radiotherapy
- •uncontrollable active infection except cholangitis
- •severe comorbid disease (cardiac, pulmonary, cerebrovascular)
结局指标
主要结局
Incidence of Infectious Complications After Biliary Drainage
时间窗: within 120 days after drainage
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
次要结局
- Change in Total Serum Bilirubin After Drainage(within 14 days after drainage)
- Total Hospital Cost During Admission After Biliary Drainage(during hospital stay for biliary drainage procedure)
研究者
Sun-Whe Kim
Professor
Seoul National University Hospital