Gastric Cancer
Conditions
Brief summary
This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.
Interventions
DRUGIndocyanine green
A one time injection of IDC prior to the day of scheduled surgery.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive ICG fluorescence lymph nodes | Approximately 30-90 days after surgery | Total number of lymph nodes removed after surgery that are positive for ICG fluorescence |
| Disease positive lymph nodes | 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 | 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 |
Countries
United States
Outcome results
None listed