Using indocyanine green tracer in laparoscopic surgery for advanced gastric cancer
Prospective Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With D2 Extra-regional Lymph Node Dissection for Locally Advanced Gastric Cancer (FUGES-30)
This study tests if using a special dye during laparoscopic surgery can help improve outcomes for patients with advanced stomach cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 760 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06945718 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the clinical outcomes of using indocyanine green tracer during laparoscopic gastrectomy with extended lymphadenectomy beyond D2 for patients with locally advanced gastric adenocarcinoma. The focus is on determining whether this approach improves clinical efficacy compared to traditional methods. Patients aged 18 to 75 with specific cancer staging criteria will be included, and the study will assess the effectiveness of the surgical intervention in a controlled setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced gastric adenocarcinoma who meet specific staging and health criteria.
Not a fit: Patients with severe mental disorders, previous upper abdominal surgeries, or other malignant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and improve survival rates for patients with advanced gastric cancer.
How similar studies have performed: While the use of indocyanine green tracer in surgical oncology is gaining interest, this specific application in advanced gastric cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky lymph nodes in D3 region. Other malignant disease within the past 5 years History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement for simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)\<50% of predicted values Diffuse invasive gastric cancer Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum History of an iodine allergy 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, Prof. — Fujian Medical University Union Hospital
- Study coordinator: Mi Lin, phD
- 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.