NCT06354036

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	the Transhiatal Tunnel Valvuloplasty technique	The ThTV esophagogastrostomy procedure involved placing a lengthy gastric tube into the lower mediastinum, firmly bound to the esophagus.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-04-09
• Last updated: 2024-04-10

Locations

1 site across 1 country: China