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

Mayo Clinic

Status and phase

Withdrawn

Phase 4

Conditions

Gastric Cancer

Treatments

Drug: Indocyanine green

Study type

Interventional

Funder types

Other

Identifiers

20-002747

Details and patient eligibility

About

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.