Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy

NCT ID: NCT06354036

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-01

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ThTV（the Transhiatal Tunnel Valvuloplasty technique group）

Patients who meet the inclusion criteria will undergo ThTV anastomosis after proximal gastrectomy

Group Type: EXPERIMENTAL

the Transhiatal Tunnel Valvuloplasty technique

Intervention Type: PROCEDURE

The ThTV esophagogastrostomy procedure involved placing a lengthy gastric tube into the lower mediastinum, firmly bound to the esophagus.

Interventions

the Transhiatal Tunnel Valvuloplasty technique

The ThTV esophagogastrostomy procedure involved placing a lengthy gastric tube into the lower mediastinum, firmly bound to the esophagus.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dong Bing Zhao

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Dongbing Zhao

Role: CONTACT

dbzhao@cicams.ac.cn

87787121

Facility Contacts

Dongbing R Zhao, M.D.

Role: primary

dbzhao2003@sina.com

+86-13901331816

Other Identifiers

NCC4465

Identifier Type: -

Identifier Source: org_study_id