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NCT06354036Recruiting

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy,Phase II Trial
Cancer Institute and Hospital, Chinese Academy of Medical SciencesClinicalTrials.govprocedure
Study focus
Disease/Condition
Gastric Cancer
Drug/Device/Intervention
the Transhiatal Tunnel Valvuloplasty technique
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Location
Beijing, China
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2023
End date
Mar 01, 2025
Enrollment
30 participants
Primary outcome

The incidence of postoperative reflux esophagitis

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.

ICD-10 classifications
Gastric ulcerMalignant neoplasm of stomachMalignant neoplasm: Body of stomachCarcinoma in situ: StomachMalignant neoplasm: Stomach, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06354036
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06354036 through Pure Global AI's free database. This phase not specified trial is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences and is currently Recruiting. The study focuses on Gastric Cancer. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.