A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

Launched by HUASHAN HOSPITAL · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new surgical method for treating gastric cancer, specifically a type called adenocarcinoma located at the upper part of the stomach or the junction between the stomach and esophagus. Researchers want to find out how safe this innovative technique is during and after surgery. The study will enroll 30 patients who are between 18 and 75 years old and have been diagnosed with this type of cancer. To participate, patients should not have had previous major surgeries in the upper abdomen, should not be receiving other cancer treatments before surgery, and must have certain health conditions assessed by doctors.

Participants in this trial can expect to undergo a laparoscopic surgery, which is a minimally invasive technique that uses small incisions. After the surgery, they will be monitored for at least three months to check for any complications and to evaluate their quality of life using specific questionnaires. The goal is to gather important information about the safety and effectiveness of this new surgical approach, which could potentially improve treatment options for patients with similar conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 75 years old;
• • 2. Pathologically confirmed as adenocarcinoma;
• • 3. Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
• • 4. If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
• • 5. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
• • 6. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
• • 7. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
• • 8. No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
• • 9. Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.
• • 10. Preoperative ASA (American Society of Anesthesiologists) score I-III.
• • 11. Good function of important organs.
• • 12. Signed informed consent.
• Exclusion Criteria:
• • 1. Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
• • 2. Pregnant or lactating women;
• • 3. Patients with severe mental illness;
• • 4. Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
• • 5. Severe respiratory diseases, with FEV1 \< 50% of predicted value;
• • 6. History of other malignant tumors in the past 5 years;
• • 7. Severe liver or kidney dysfunction;
• • 8. Unstable angina or myocardial infarction within the last 6 months;
• • 9. History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
• • 10. Systemic use of glucocorticoids within the last 1 month;
• • 11. Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
• • 12. Patient has participated in or is currently participating in other clinical trials (within the last 6 months).