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

Overview

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

Full Title of Study: “Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2022

Interventions

  • Drug: Indocyanine green
    • A one time injection of IDC prior to the day of scheduled surgery.

Arms, Groups and Cohorts

  • Other: Intervention
    • Injection of Indocyamine Green.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Enrique F. Elli, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Enrique F Elli, MD, Principal Investigator, Mayo Clinic

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