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

Gastric Cancer Clinical Trial

Official title:

Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04591028
• Other study ID #: 20-002747
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2022
• Est. completion date: August 10, 2022

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 10, 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive ICG fluorescence lymph nodes	Total number of lymph nodes removed after surgery that are positive for ICG fluorescence	Approximately 30-90 days after surgery
Primary	Disease positive lymph nodes	Number of ICG positive lymph nodes that are also positive for disease	Approximately 30-90 days after surgery
Primary	Number of lymph nodes removed for each lymphatic station of gastrectomy	Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG	Approximately 30-90 days after surgery

External Links

•   Mayo Clinic Clinical Trials