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

Phase 4

Withdrawn

• Conditions: Gastric Cancer
• Interventions: Drug: Indocyanine green

• Registration Number: NCT04591028
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Study Start: 2022-01
• Primary Completion: 2022-01
• Study Completion: 2022-08-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Indocyanine green	Injection of Indocyamine Green.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States