Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: the Transhiatal Tunnel Valvuloplasty technique

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongbing Zhao; Phone Number: 87787121; Email: dbzhao@cicams.ac.cn

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • 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
    • Contact: Dongbing R Zhao, M.D.; Phone Number: +86-13901331816; Email: dbzhao2003@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ThTV（the Transhiatal Tunnel Valvuloplasty technique group）; Patients who meet the inclusion criteria will undergo ThTV anastomosis after proximal gastrectomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative reflux esophagitis	postoperative reflux	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of postoperative anastomotic fistula	Postoperative anastomotic fistula	1 year
the incidence of anastomotic stenosis	postoperative anastomotic stenosis	1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Valvulopathy; Proximal gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: NCC4465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No