NCT06929949Recruiting
The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 12 Mar 2025
- Start date
- 25 Nov 2024
- Primary completion date
- 25 Nov 2028
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06929949
What you commit to
- Study type: Observational
- Planned participants: 90
- From 25 Nov 2024 to the primary completion date, 25 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received preoperative radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Other illness
- 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.
- 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.
- Patients requiring emergency surgery due to tumor-related complications (e.g., bleeding, perforation, or obstruction).
Other
- Evidence of distant metastasis diagnosed by thoracoabdominal CT/MRI or PET-CT.
- Pregnant or lactating women.
- Pulmonary function test showing FEV1 \< 50% of the predicted value.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.