Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

Launched by FUJIAN MEDICAL UNIVERSITY · Jul 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special dye called indocyanine green (ICG) during a type of surgery called laparoscopic distal gastrectomy, which is used to remove part of the stomach in patients with early gastric cancer. The main goal is to see if ICG can help doctors better identify cancerous lymph nodes during surgery, which could improve treatment outcomes for patients. The trial is looking for participants aged 18 to 75 who have been diagnosed with a specific type of early-stage stomach cancer and meet certain health criteria.

To be eligible for the trial, participants should have early gastric adenocarcinoma that has not spread to other parts of the body and is located in the lower third of the stomach. They should also be in good general health, meaning they can carry out daily activities without much difficulty. Those who are pregnant, have had certain previous surgeries, or have other serious health issues may not qualify. Although the trial is not yet recruiting, those who participate can expect to undergo a minimally invasive surgery with the potential benefit of improved cancer detection during the procedure.

Gender

ALL

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. Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
• • 4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
• • 5. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
• • 6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
• • 7. American Society of Anesthesiology score (ASA) class I, II, or III
• • 8. Written informed consent
• Exclusion Criteria:
• • 1. Women during pregnancy or breast-feeding
• • 2. Severe mental disorder
• • 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
• • 4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
• • 5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
• • 6. History of other malignant disease within past five 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 of simultaneous surgery for other disease
• • 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• • 13. Forced expiratory volume in 1 second (FEV1)\<50% of predicted values
• • 14. Rejection of laparoscopic resection
• • 15. Preoperatively confirmed tumors invading the dentate line or duodenum
• • 16. History of allergy to iodine agents
• • 17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy