Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer
Overview
- Phase
- Phase 4
- Intervention
- Indocyanine green
- Conditions
- Gastric Cancer
- Sponsor
- Mayo Clinic
- Locations
- 1
- Primary Endpoint
- Positive ICG fluorescence lymph nodes
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.
Investigators
Enrique F. Elli
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Patients ≥ 18 and ≤ 75 years of age.
- •Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
- •Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
- •No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
- •American Society of Anesthesiology score (ASA) class I, II, or III.
- •Written informed consent.
Exclusion Criteria
- •Patients ≤ 18 and ≥ 75 years of age.
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
- •History of allergy to iodine agents.
- •History of other malignant disease within past five years.
- •Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
- •Patients intraoperatively/postoperatively confirmed as T4b.
- •Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.
Arms & Interventions
Intervention
Injection of Indocyamine Green.
Intervention: Indocyanine green
Outcomes
Primary Outcomes
Positive ICG fluorescence lymph nodes
Time Frame: Approximately 30-90 days after surgery
Total number of lymph nodes removed after surgery that are positive for ICG fluorescence
Disease positive lymph nodes
Time Frame: Approximately 30-90 days after surgery
Number of ICG positive lymph nodes that are also positive for disease
Number of lymph nodes removed for each lymphatic station of gastrectomy
Time Frame: Approximately 30-90 days after surgery
Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG