Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Complication
研究概览
简要总结
The investigators compared the perioperative, oncological, functional and immunological outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain induced, endoscopic submucosal dissection is expected to be less invasive when compared to laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show that endoscopic submucosal dissection is associated with a significantly better perioperative recovery and less immunological disturbance. Moreover, it will also induce a better long term outcomes as the stomach can be preserved, hence the digestive function is maintained to prevent long term functional morbidities of the gastrointestinal tract.
This study will be the unique first study in the literature to show that intramucosal early gastric cancer can be adequately treated by endoscopic submucosal dissection with better perioperative, functional and quality of life outcomes when compared to laparoscopic assisted gastrectomy.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type)
- •Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion
- •Any tumor size if the early gastric cancer has no ulceration
- •Tumor size ≤ 3cm if the early gastric cancer has ulceration
排除标准
- •Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond submucosal invasion
- •Poorly differentiated or signet ring cell adenocarcinoma
- •Age > 80 or < 16
研究组 & 干预措施
ESD Group
Endoscopic Submucosal Dissection
干预措施: Endoscopic Submucosal Dissection (Procedure)
LAG Group
Laparoscopic Assisted Gastrectomy
干预措施: Laparoscopic assisted Gastrectomy (Procedure)
结局指标
主要结局
Complication
时间窗: 30 days after procedure
次要结局
- Recurrence(up to 5 years after operation)
- Overall Survival(up to 5 years after operation)
- Postop VAS score on pain measurement(30 days)
- Mortality(30 days after procedure)
- Time (hours) for Operative(Up to 24 hours)
- Quality of life assessment by SF36(From date of operation on every followup appointment until 24 months after operation)
- Disease free survival(up to 5 years after operation)
- Hospital stay(through study completion, an average of 1 year)
研究者
Philip Wai Yan Chiu
Professor
Chinese University of Hong Kong