Water-injecting Endoscopic Submucosal Dissection for Early Gastric Cancer: a Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 548
- 试验地点
- 1
- 主要终点
- Total procedure time
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is a technically difficult and time-consuming procedure. Several water-jet knives have been developed to address this issue. The aim of this study was to develop a new ESD method using continuous low-pressure water injection at 1-2 atmosphere with a tip-injected electric knife while dissection simultaneous cutting, dissection, electrocoagulation, and hemostasis, which was so called as water-injecting ESD (W-ESD) to treat early gastric cancer and compare the efficacy and safety with conventional methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •age ≥ 18 years;
- •histologically proven early gastric adenocarcinoma;
- •meeting the absolute or expanded indication for ESD according to the Japanese gastric cancer treatment guidelines 2021 ;
- •Eastern Cooperative Oncology Group performance status ≤ 2;
- •adequate hematological function (hemoglobin ≥ 9 g/dL, platelets ≥ 50 000/mm3，international normalized ratio<1.5);
- •sufficient renal function (serum creatinine ≤ 2.0 mg/dL); and (7) adequate hepatic function (serum aspartate aminotransferase ≤ 100 IU/L, serum alanine aminotransferase ≤ 100 IU/L).
排除标准
- •pregnancy or breastfeeding;
- •difficulty obtaining consent due to psychiatric disorder;
- •multiple lesions;
- •history of gastrectomy or gastrointestinal reconstruction surgery.
结局指标
主要结局
Total procedure time
时间窗: Immediately after surgery
Average time to complete endoscopic resection
Circumferential incision time
时间窗: Immediately after surgery
Average time for APC labeling of the lesion margin during circumferential incision
Dissection time
时间窗: Immediately after surgery
Average time to complete endoscopic dissection
Dissection speed
时间窗: Immediately after surgery
Average speed of endoscopic dissection
次要结局
- Completeness of en bloc resection(Immediately after surgery)
- Adverse event rate(Immediately after surgery and one month post-surgery)
研究者
Yingjie Ji
Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital
Shanghai East Hospital