Evaluating how different surgical methods affect quality of life after stomach surgery
A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
This study is testing how different types of stomach surgery affect the quality of life for people recovering from early-stage gastric cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06929949 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of various digestive tract reconstruction methods on postoperative quality of life in patients undergoing proximal gastrectomy for early-stage gastric cancer and adenocarcinoma of the esophagogastric junction. The study aims to compare the outcomes of total gastrectomy and proximal gastrectomy, focusing on the preservation of gastrointestinal function and overall patient well-being. By analyzing patient data, the research seeks to identify the optimal surgical approach that minimizes long-term quality-of-life issues associated with gastric cancer surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with early-stage proximal gastric cancer or esophagogastric junction cancer who are undergoing proximal gastrectomy.
Not a fit: Patients with advanced gastric cancer or those who cannot tolerate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that enhance the quality of life for patients recovering from gastric cancer surgery.
How similar studies have performed: Previous studies have shown promising results with laparoscopic proximal gastrectomy, indicating that this approach may be effective, though the specific comparisons in this study are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients who have received preoperative radiotherapy, chemotherapy, targeted therapy, or immunotherapy. * Presence of multiple malignant tumors in the stomach. * History of upper abdominal surgery, except for laparoscopic cholecystectomy. * History of gastric surgery, except for endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) for gastric cancer. * Evidence of distant metastasis diagnosed by thoracoabdominal CT/MRI or PET-CT. * Pregnant or lactating women. * History of uncontrolled epilepsy, central nervous system disorders, or psychiatric illness. * Patients with limb disabilities or motor function impairment. * History of other malignant diseases within the past five years, except for cured skin cancer and cervical carcinoma in situ. * Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medical intervention, or myocardial infarction within the past six months. * History of stroke or cerebral hemorrhage within the past six months. * Severe, uncontrolled recurrent infections or other serious uncontrolled comorbidities. * Pulmonary function test showing FEV1 \< 50% of the predicted value. * Patients requiring emergency surgery due to tumor-related complications (e.g., bleeding, perforation, or obstruction).
Where this trial is running
Changchun, Jilin
- First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Quan Wang, Professor
- Email: wquan@jlu.edu.cn
- Phone: +86 15843073207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.