NCT06217991Enrolling By Invitation不适用
A Single-center, Prospective, Single-arm Clinical Study of Laparoscopic Proximal Gastrectomy Based on an Original Esophagogastric Anastomose (PTST,Parachute- Tunnel- Style Technique)
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- occurrence rate of reflux esophagitis
研究概览
简要总结
- To evaluate the safety, simplicity and effectiveness of the gastric function (anti-reflux) preservation of the innovative "parachute-tunnel-style technique" (PTST) in laparoscopic proximal gastrectomy.
- To investigate the correlation between anastomotic stenosis and blood supply of serosa-muscle flap,suture after esophagogastric anastomosis.(obtain objective indexes such as blood supply, healing pattern and length change of serosa-muscle flap through animal experiments)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric cancer was confirmed histopathologically;
- •Patients who may undergo proximal gastrectomy according to guidelines;
- •Early upper gastric cancer, more than 1/2 of the distal gastric remnant remained after resection;
- •Esophagogastric junction carcinoma with maximum diameter ≤4 cm;
- •Patients with advanced upper gastric cancer (MSI-H) achieved cCR by neoadjuvant immunochemotherapy.
排除标准
- •Patients with systemic conditions that cannot tolerate laparoscopic surgery;
- •Distal gastric remnant was less than 1/2 after proximal gastrectomy.
结局指标
主要结局
occurrence rate of reflux esophagitis
时间窗: three month after surgery; six month after surgery
* Visick score after surgery * Los Angeles rating
occurrence rate of anastomotic stenosis
时间窗: one month after surgery
morbidity(%)
次要结局
未报告次要终点
研究者
研究点 (1)
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