JPRN-jRCT2052210020已完成未知
Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction - HG01
Kitano Masayuki0 个研究点目标入组 40 人开始时间: 2021年5月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Ages of more than 20 years old when obtaining informed consent
- •(2) Malignancy of pathological diagnosis
- •(3) Biliary obstruction due to unresectable malignant tumors
- •(4) Failured, impossible or difficult in biliary drainage with ERCP
- •(5) Serum bilirubin level of higher than 3.0 mg/dl before enrollment
- •(6) Obtaining the document for informed consent from the patient
排除标准
- •(1) Impossible to perform endoscopy
- •(2) After total gastrectomy
- •(3) After left hepatectomy
- •(4) Bismuth classification for hilar biliary carcinoma : Type IIIb or Type IV
- •(5) Liver cirrhosis
- •(6) Ascites around the liver on CT
- •(7) With PTBD tube at obtaining informed consent
- •(8) Planned insertion of metal stent in the upper gastrointestinal tract within 7 days before treatment
- •(9) Performance status 4
- •(10) Severe other diseases in the heart, lund, kidney and/or liver. ASA 4 or higher
- •(11) Poor general condition and estimated prognosis of less than 2 months
- •(12) Hemorrhagic diathesis including fetal aneurisms or severe coagulation disorder
- •(13) Participating in the other clinical trials (except non-intervention)
- •(14) Women who may possibly be pregnant or wants to be pregnant
- •(15) Metal allergy to nickel-titanium
- •(16) Know allergy to iodine contrast agents according to anaphylaxis guideline
- •(17) Patients whom the investigators decide inappropriate to participate in the trial
研究者
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