3D laparoscopic surgery using a special imaging technique for gastric cancer
Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer
This study is testing if using a special imaging technique during 3D laparoscopic surgery can help patients with advanced stomach cancer live longer and healthier after their surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 702 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06161207 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety, efficacy, and feasibility of using Indocyanine Green (ICG) near-infrared imaging during 3D ultra high resolution laparoscopic gastrectomy with lymph node dissection for patients with locally advanced gastric adenocarcinoma. The study involves a prospective, single-center, randomized controlled design with three groups: one receiving the ICG imaging with 3D laparoscopic surgery, another receiving ICG imaging without 3D, and a control group undergoing standard 3D laparoscopic surgery. The primary outcome measure is the three-year disease-free survival rate, aiming to determine if the experimental groups show improved outcomes compared to the control group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced gastric adenocarcinoma who meet specific staging criteria.
Not a fit: Patients with distant metastasis, severe mental disorders, or a history of significant prior abdominal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and higher disease-free survival rates for patients with gastric cancer.
How similar studies have performed: Previous studies have shown promising results with similar imaging techniques in surgical oncology, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age from 18 to 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition 4. No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations 5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) class I to III 7. Written informed consent Exclusion Criteria: 1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. History of previous gastric surgery (including ESD/EMR for gastric cancer) 5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging 6. Other malignant disease within the past 5 years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within past six months 9. History of cerebrovascular accident within past six months 10. History of continuous systematic administration of corticosteroids within one month 11. Requirement for simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. FEV1 (forced expiratory volume in one second)\<50% of predicted values 14. Diffuse invasive gastric cancer 15. History of an iodine allergy 16. Patients who declined laparoscopic surgery
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Chang-ming Huang — Fujian Medical University Union Hospital
- Study coordinator: Mi Lin
- Email: silihuala@qq.com
- Phone: 13459152658
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.