Indocyanine Green Tracer Using in Laparoscopic Radical Gastrectomy for Locally Advanced Gastric Cancer

Launched by FUJIAN MEDICAL UNIVERSITY · Oct 16, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging technique using a special dye called Indocyanine Green (ICG) to help guide surgeons during laparoscopic surgery for patients with locally advanced gastric cancer. The study aims to determine how safe and effective this imaging method is compared to traditional surgery techniques. Participants will be split into two groups: one will receive the ICG injection to help visualize lymph nodes during surgery, while the other group will not receive the injection.

To be eligible for this trial, participants should be between 18 and 75 years old and have a confirmed diagnosis of primary gastric adenocarcinoma. They should not have any other serious health conditions or a history of certain previous surgeries related to the stomach. Those who take part in the trial can expect to undergo laparoscopic surgery with close monitoring and support from the medical team. It's important to know that this trial is currently active but not recruiting new participants, meaning they are not looking for additional patients at this time.

Gender

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Eligibility 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 including enlarged or bulky No.10 lymph nodes
• • 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. Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum
• • 16. History of an iodine allergy
• • 17. Patients who declined laparoscopic surgery