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临床试验/NCT02787512
NCT02787512已完成不适用

A Randomized Controlled Trial for Preoperative Biliary Drainage With Metal Versus Plastic Stents in Patients With Periampullary Cancer

Seoul National University Hospital3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
3
主要终点
Reintervention rate until operation

研究概览

简要总结

Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.

The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.

详细描述

Jaundice is one of the most common symptoms in patients with periampullary cancers including pancreatic cancer, common bile duct (CBD) cancer, ampulla of Vater (AoV) cancer, and duodenal cancer. Traditionally, preoperative biliary drainage (PBD) was routinely performed in these cancers because it might favorably influence sepsis, endotoxemia, and intravascular coagulation. However, a recent randomized control study reported that routine PBD in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. Therefore, routine PBD was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.

In these patients with necessity of PBD, a plastic stent (PS) has been used because it is good for temporary use with cheap prices. However, it is sometimes occluded before surgery or not enough for rapid decompressing jaundice mainly because of its short diameter. In this aspect, a self-expandable metal stent (SEMS) has strength compared to PS because it has a longer diameter which enables rapid decompression with a fewer events of occlusion. However, SEMS is much more expensive than PS and the exact length of stent is more critical.

Although there are still lack of evidence which compares the results between PS and SEMS, National Comprehensive Cancer Network (NCCN) guidelines recently recommended the use of a short SEMS for pancreatic adenocarcinoma patients with cholangitis or fever. However, we needed more concrete evidence about this principle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A. Patients 20-80 years old B. Patients with surgically resectable periampullary cancer on CT scans with or without MRI or PET-CT scans C. ECOG Performance score 0 or 1 D. Patients who need preoperative biliary drainage (PBD) because of one or more of following causes
  • Cholangitis defined as revised Tokyo guidelines
  • Level of total bilirubin >= 10mg/dL
  • Expected time to operation >= 7 days

排除标准

  • A. Patients who received previous endoscopic biliary drainage or percutaneous biliary drainage B. Patients with acute pancreatitis before PBD
  • C. Patients with bleeding tendency or coagulopathy or anticoagulation therapy as follows:
  • Patients who take clopidogrel within 5 days before PBD
  • Patients who take warfarin within 2 days before PBD
  • Patients who receive heparin within 1 days before PBD D. Patients with pregnancy or suspected pregnancy E. Patients who are currently enrolled in another investigational trials that would directly interfere with current study

研究组 & 干预措施

Plastic stent

Active Comparator

10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent)

干预措施: Stent (Device)

Uncovered metal stent

Experimental

Uncovered metal stent (WallFlex® Biliary RX stent)

干预措施: Stent (Device)

结局指标

主要结局

Reintervention rate until operation

时间窗: Between preoperative biliary drainage and surgery

Between preoperative biliary drainage and surgery, reintervention (re-preoperative biliary drainage) would be checked and analyzed.

次要结局

  • Other complication rate associated with endoscopic stent insertion and stent indwell(Between preoperative biliary drainage and surgery)
  • Mortality until 3 months after pancreaticoduodenectomy(3 month)
  • Rate of decrease of total bilirubin(Between preoperative biliary drainage and surgery)
  • Time to operation(Between preoperative biliary drainage and surgery)
  • Time to hospital discharge after pancreaticoduodenectomy(6 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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