New surgical technique for gastric cancer treatment
Application of Hao's Esophagogastrostomy by Fissure Technique: a Prospective, Multicenter Randomized Controlled Study
This study is testing a new surgical method for gastric cancer to see if it helps patients recover better and have improved nutrition compared to the traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Shanghai and 2 other locations) |
| Trial ID | NCT06679244 on ClinicalTrials.gov |
What this trial studies
This study evaluates an innovative surgical method called Hao's Esophagogastrostomy by Fissure Technique (HEFT) for patients undergoing proximal gastrectomy due to gastric cancer. It is a multicenter, randomized, controlled trial comparing HEFT with traditional double-tract reconstruction. The study aims to assess nutritional status and safety outcomes post-surgery, building on previous findings that suggest HEFT is safe and feasible. The goal is to improve surgical outcomes and patient recovery through enhanced techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with upper gastric adenocarcinoma eligible for proximal gastrectomy.
Not a fit: Patients with a history of upper abdominal surgery or those who have received prior cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better quality of life for gastric cancer patients.
How similar studies have performed: Previous studies have indicated that innovative surgical techniques can improve outcomes, but this specific approach is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years old ≤ 80 years old; 2. The primary tumor lesion is located in the upper part of the stomach or the esophagogastric junction (Siewert II or III), and it is expected that R0 surgical results can be obtained by performing proximal gastrectomy and D2 dissection； 3. The primary lesion was diagnosed as adenocarcinoma through endoscopic biopsy and histopathological examination; 4. If it is upper gastric adenocarcinoma, the clinical TNM staging based on imaging needs to be cT1N0M0. If it is ductal gastric junction adenocarcinoma, it needs to be cT1-3N0-1M0, and clinical imaging judgment shows no distant gastric lymph node metastasis； 5. Expected survival exceeds 6 months; 6. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy); 7. No chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. were performed before surgery; 8. Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1; 9. Preoperative ASA (American Society of Anesthesiologists) grading I-III ; 10. Good function of important organs; 11. Sign the patient's informed consent form Exclusion Criteria: 1. Preoperative imaging examination suggests the fusion of enlarged lymph nodes (maximum diameter ≥ 3cm) in the area; 2. Pregnant and lactating women; 3. Suffering from other malignant tumors within 5 years; 4. Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment; 5. Serious mental illness; 6. Severe respiratory diseases, FEV1\<50% of the expected value; 7. Severe liver and kidney dysfunction; 8. History of unstable angina or heart attack within 6 months; 9. History of cerebral infarction or cerebral hemorrhage within 6 months, excluding old intracavitary infarction; 10. Apply systemic corticosteroid therapy within one month; 11. Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery; 12. The patient has participated or is currently participating in other clinical studies (within 6 months)
Where this trial is running
Shanghai and 2 other locations
- Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
- Huashan Hospital, Fudan University — Shanghai, China (Recruiting)
- Second Department of Gastric Surgery, Fudan University Shanghai Cancer Center, — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Hankun Hao, doctor
- Email: haohankun@163.com
- Phone: +86 18121186328
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.