JPRN-jRCT1032230171招募中3 期
Multicenter Randomized Controlled Trial of Endoscopic Stenting with Duckbill type Anti-Reflux Metal Stent vs Conventional Covered Metal Stent for Malignant Distal Biliary Obstruction after Dysfunction of Previous Covered Metal Stent in Unresectable Pancreatic Cancer - RESTART trial
Sasahira Naoki0 个研究点目标入组 154 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Unresectable pancreatic cancer
- •2)Prior history of one endoscopic stenting with covered metal stent
- •3)Dysfunction of previous covered metal stent
- •4)Age >= 18 years
- •5)Performance status of 0-2
- •6)Expected survival time over 3 months
- •7)Sufficient organ function
- •1.Neutrophil count >= 1,000 /microL
- •2.Hemoglobin level >= 7.0 g/dL
- •3.Platelet count >= 50,000 /microL
- •4.Total bilirubin level =< 10 mg/dL
- •5.Aspartate aminotransferase level =< 300 U/L
- •6.Alanine aminotransferase level =< 300 U/L
- •7.Creatinine level =< 2.0 mg/dL
- •8)Patients who provided a written consent
排除标准
- •1)Concomitant hilar biliary obstruction
- •2)Patients who require more than one biliary stent
- •3)Unable to remove the previous covered metal stent
- •4)Surgically altered anatomy other than Billroth 1 reconstruction
- •5)Indwelling Pholangitis
- •7)Cholecystitis requiring gallbladder drainage
- •8)Liver abscess requiring abscess drainage
- •9)Liver failure
- •10)Indwelling gastroduodenal stent covering the duodenal papilla
- •11)Uncontrolled gastrointestinal obstruction
- •12)Massive ascites requiring palliative paracentesis
- •13)Patients who would become lost to follow up right after metal stent placement
- •14)Patients who are pregnant or may become pregnant
- •15)Patients who are considered inappropriate by the investigator
研究者
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