Innovative surgical technique for treating gastric cancer
A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique
NA · Huashan Hospital · NCT06300879
This study is testing a new surgical technique for treating gastric cancer to see if it is safe and helps patients recover better after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Huashan Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06300879 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and outcomes of a new surgical method for patients with adenocarcinoma located in the upper stomach or gastroesophageal junction. It involves a totally laparoscopic proximal gastrectomy with esophagogastrostomy using a fissure technique. A total of 30 patients will be enrolled, and their clinical data will be monitored for perioperative safety and postoperative complications over a follow-up period of at least three months. Quality of life will also be assessed using specific questionnaires.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed adenocarcinoma located in the upper third of the stomach or gastroesophageal junction.
Not a fit: Patients with a history of upper abdominal surgery or those who have received preoperative treatments like chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this innovative surgical technique could improve postoperative outcomes and quality of life for patients with gastric cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promising results with laparoscopic techniques in gastric cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
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.
Conditions: Gastric Cancer, Adenocarcinoma of Esophagogastric Junction, proximal gastrectomy, totally laparoscopic gastrectomy, fissure technique