JPRN-jRCTs052220071招募中3 期
Phase III study of waterjet versus ultrasonic device in transection efficacy during anatomical liver resection - WAUTEAR trial
eno Masaki0 个研究点目标入组 250 人开始时间: 2022年8月9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
- 250
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) Age 20 years or older.
- •(2) ECOG Performance Status 0 to 2.
- •(3) Written consent provided.
- •(4) Scheduled to undergo (open/laparoscopic) liver resection due to liver disease, or to undergo liver resection as a donor for living-donor liver transplantation.
- •(5) Scheduled to undergo the following surgical procedures: right lobectomy, left lobectomy, right posterior sectionectomy, segment VII segmentectomy (for patients with liver disease) and right lobectomy, left lobectomy (for donors)
排除标准
- •(1) Venous tumor thrombus (Vv2, 3).
- •(2) Biliary tumor thrombus (B3, 4).
- •(3) Needing biliary or vascular reconstruction.
- •(4) Dissection area overlaps with area of previous partial hepatectomy.
- •(5) Difficulty in taping hepatoduodenal ligament.
- •(6) Requiring resection of other organs except for gallbladder.
- •(7) BMI of 30 or more.
- •(8) Child-Pugh grade B or C.
- •(9) Platelet count <=10x104/micro-L.
- •(10) NYHA grade III or more.
- •(11) Implanted cardiac pacemaker or cardioverter defibrillator.
- •(12) Severe renal dysfunction (serum Cr >1.5 mg/dL).
- •(13) Severe respiratory dysfunction (forced expiratory volume in 1 second <1L or requiring rest because of shortness of breath during 100m or several minutes' walking).
- •(14) Other non-appropriate conditions, as determined by the principal investigator.
研究者
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