Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354036
• Other study ID #: NCC4465
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Dongbing Zhao
• Phone: 87787121
• Email: dbzhao[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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;

2. Tumor diameter<4cm, with no distant metastasis;

3. Clinical staging T1-3N0-1M0;

4. On the basis of proximal gastrectomy, 50% of the gastric volume can still be retained;

5. ECOG-PS status score 0-1 points (Eastern Cooperative Oncology Group).

Exclusion Criteria:

1. Patients undergoing preoperative neoadjuvant chemotherapy;

2. Patients with severe cardiovascular and pulmonary diseases who cannot tolerate laparoscopic surgery;

3. Incomplete clinical data.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative reflux esophagitis	postoperative reflux	1 year
Secondary	the incidence of postoperative anastomotic fistula	Postoperative anastomotic fistula	1 year
Secondary	the incidence of anastomotic stenosis	postoperative anastomotic stenosis	1 year