Pure Global

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy - Trial NCT06354036

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06354036
Recruiting
procedure
Trial Details
ClinicalTrials.gov โ€ข NCT06354036
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy๏ผŒPhase II Trial

Study Focus

Gastric Cancer

the Transhiatal Tunnel Valvuloplasty technique

Interventional

procedure

Sponsor & Location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Timeline & Enrollment

N/A

Mar 01, 2023

Mar 01, 2025

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 ulcer
Malignant neoplasm of stomach
Malignant neoplasm: Body of stomach
Carcinoma in situ: Stomach
Malignant neoplasm: Stomach, unspecified

Data Source

ClinicalTrials.gov

NCT06354036

Non-Device Trial