A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Gastric cancer ranks as the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. In China, its incidence and mortality rank third among all cancers. While the global incidence of gastric cancer is declining, proximal gastric cancer and adenocarcinoma of the esophagogastric junction (AEG) are on the rise. Due to the unique characteristics of AEG, there is no standardized treatment consensus, making the selection of an optimal surgical approach and reconstruction method crucial for improving patient outcomes. For early-stage proximal gastric cancer and AEG, total gastrectomy (TG) and proximal gastrectomy (PG) are common surgical options. PG, increasingly favored for its function-preserving benefits, has been shown to be a safe and effective alternative to TG. While TG effectively removes lymph nodes and reduces reflux risk, it leads to permanent loss of gastric function and nutritional deficiencies. PG better preserves gastrointestinal function but is limited by the risk of reflux esophagitis, highlighting the need for improved reconstruction techniques. Several reconstruction methods exist after PG, including esophagogastric anastomosis, jejunal interposition, double-tract reconstruction (DTR), double-flap technique (DFT), and tubular gastric anastomosis, each with varying efficacy in preventing reflux. Studies suggest that DTR reduces reflux and improves quality of life compared to esophagogastric anastomosis, while DFT, first introduced in 1998, has gained popularity for its advantages in maintaining nutrition and minimizing reflux. Additionally, tubular gastric anastomosis, which constructs a narrow gastric tube to facilitate tension-free anastomosis, has shown potential benefits for AEG patients. Most existing studies on laparoscopic or robot-assisted reconstruction techniques for proximal gastric cancer are retrospective, lacking high-quality prospective evidence. Furthermore, comparative data on their anti-reflux efficacy and postoperative quality of life remains l

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age from over 18 to under 75 years.

• Preoperative gastroscopic pathological biopsy was performed, and histologically confirmed as carcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma, etc.) or adenoma.

• Diagnosed with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0) or esophagogastric junction cancer with a diameter ≤4 cm based on the 8th edition of the AJCC staging system, as confirmed by CT, MRI, endoscopic ultrasound, and pathology.

• Undergoing proximal gastrectomy with D2 lymphadenectomy is expected to achieve curative resection, with the remaining gastric volume required to be at least half of the pre-resection volume.

• Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale.

• ASA (American Society of Anesthesiology) class I to III.

• The patient has adequate organ function and is capable of tolerating surgery.

• Written informed consent.

Locations
Other Locations
China
First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Quan Wang, Professor
wquan@jlu.edu.cn
+86 15843073207
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2030-11-25
Participants
Target number of participants: 90
Treatments
Double-flap technique (DFT)
The DFT digestive tract reconstruction was performed in patients with gastric cancer after proximal gastrectomy
double-tract reconstruction (DTR)
The DTR digestive tract reconstruction was performed in patients with gastric cancer after proximal gastrectomy
Tubular gastric anastomosis (TGA)
The TGA digestive tract reconstruction was performed in patients with gastroesophageal cancer after proximal gastrectomy
Sponsors
Leads: The First Hospital of Jilin University

This content was sourced from clinicaltrials.gov