Water-jet Assisted Endoscopic Submucosal Dissection (ESD) in Comparison to Conventional ESD Technique for Treatment of Early Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Procedure time
研究概览
简要总结
- Introduction The aim of the study is to evaluate the efficacy and safety of ESD by use of a new water-jet assisted ESD system using the HybridKnife® in patients with early gastric neoplastic lesions in comparison to the conventional ESD established in Japan. The water-assisted ESD technology allows pressure controlled injection of fluids through the tip of a recently developed HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions as well as coagulation of bleeding can be performed with the same device without need for changing the instrument. These options should accelerate the procedure and may increase its safety and efficacy.
- Hypothesis The water-jet assisted ESD technique using the HybridKnife® bears the advantage of less instrument changes due to the combination of high-frequency cutting and water-jet application in one single instrument. This should lead to a simplified ESD procedure, shorter learn-ing curve and especially to a shorter procedure time.
The water-jet assisted ESD technique should be shorter than the conventional ESD techniques using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (≥ 18 years) with confirmed diagnosis of gastric adenoma or early gastric adenocarcinoma
- •differentiated mucosal adenocarinoma without ulcer findings ≤ 60 mm in diameter.
- •Lesions with ulceration ≤ 30 mm in diameter.
- •undifferentiated type of mucosal cancer is ≤ 20 mm.
- •The patient has given written informed consent.
排除标准
- •pregnancy
- •coagulopathy (INR>2.0, platelets < 70/nl)
- •mucosal lesions which did not meet the inclusion criteria
- •evidence of local or distant metastases according to endoscopic ultrasound (EUS) and/or CT scan, EUS (7.5 MHz probe) findings of tumor infiltration into deep layers of the submucosa or muscularis propria. -Patients unfit for deep sedation by use of propofol
研究组 & 干预措施
Conventional ESD
Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe
干预措施: Conventional ESD (Device)
Hybridknife ESD
Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)
Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)
干预措施: Hybridknife ESD (Device)
结局指标
主要结局
Procedure time
时间窗: during procedure
The primary objective of the study is the procedure time of ESD using the conventional ESD technique in comparison to the water-jet assisted HybridKnife®-ESD technique.
次要结局
- en bloc resection rate(in procedure)
- histological R0 rate(7 days after procedure)
- procedure related morbidity and mortality and complication rate(30 days after procedure)
- complication rate(30 days after procedure)
- Histologically incomplete resection(7 days after procedure)