Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354036
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-03
Brief Title:
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal GastrectomyPhase II Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None