A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

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.