跳至主要内容
临床试验/NCT06354036
NCT06354036招募中不适用

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy,Phase II Trial

Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
The incidence of postoperative reflux esophagitis

研究概览

简要总结

Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method.

Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis.

Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed by gastroscopy pathological biopsy and imaging examination as early adenocarcinoma of the upper part of the stomach or adenocarcinoma of the esophageal gastric junction;
  • Tumor diameter<4cm, with no distant metastasis;
  • Clinical staging T1-3N0-1M0;
  • On the basis of proximal gastrectomy, 50% of the gastric volume can still be retained;
  • ECOG-PS status score 0-1 points (Eastern Cooperative Oncology Group).

排除标准

  • Patients undergoing preoperative neoadjuvant chemotherapy;
  • Patients with severe cardiovascular and pulmonary diseases who cannot tolerate laparoscopic surgery;
  • Incomplete clinical data.

结局指标

主要结局

The incidence of postoperative reflux esophagitis

时间窗: 1 year

postoperative reflux

次要结局

  • the incidence of postoperative anastomotic fistula(1 year)
  • the incidence of anastomotic stenosis(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Bing Zhao

Clinical Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (2)

Loading locations...

相似试验