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Trial Title:
Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy
NCT ID:
NCT06354036
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Proximal gastrectomy
Valvulopathy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
the Transhiatal Tunnel Valvuloplasty technique
Description:
The ThTV esophagogastrostomy procedure involved placing a lengthy gastric tube into the
lower mediastinum, firmly bound to the esophagus.
Arm group label:
ThTV（the Transhiatal Tunnel Valvuloplasty technique group）
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
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
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongbing R Zhao, M.D.
Phone:
+86-13901331816
Email:
dbzhao2003@sina.com
Start date:
March 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06354036
