Submucosal Pressure Ejection Endoscopic 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 submucosal pressure ejection endoscopic dissection (SPEED) 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.
研究组 & 干预措施
Submucosal pressure ejection endoscopic dissection (SPEED)
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 submucosal pressure ejection endoscopic dissection (SPEED).
Conventional ESD (C-ESD)
A traditional ESD model. Submucosal injection is performed separately from circumferential cutting, dissection, electrocoagulation, and hemostasis. During the submucosal dissection procedures, submucosal injection is performed with the tip of the knife first, followed by the above operations, rather than simultaneously.
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