Evaluation of the Efficacy and Safety of Indocyanine Green Tracing in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new technique for performing surgery on patients with gastric cancer, specifically looking at the use of a special dye called indocyanine green (ICG). The study aims to find out if using ICG during laparoscopic surgery (a minimally invasive surgery using small cuts) helps doctors better locate lymph nodes affected by cancer compared to traditional methods that do not use this dye. The trial is designed to see if this new method is safer and more effective for patients diagnosed with gastric adenocarcinoma, a type of stomach cancer.

To participate in this trial, patients must be between 18 and 75 years old and have a confirmed diagnosis of gastric adenocarcinoma that has not spread to other parts of the body. They should not have any serious health issues that could complicate surgery, such as recent heart problems or previous stomach surgeries. Participants in the trial will be randomly assigned to either receive the ICG during their surgery or not, and they can expect close monitoring throughout the process. It's important to know that this trial is not yet recruiting participants, so those interested will need to wait until it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18-75 years old Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion (pap, tub, muc, sig, por) The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage.
• • Preoperative examination did not show distant metastasis, and the tumor did not directly invade the pancreas, spleen and other adjacent organs.
• • Preoperative ECOG physical status score 0/1 Preoperative ASA score I-III. Patient informed consent
• Exclusion Criteria:
• • Pregnant or nursing women Serious mental illness History of upper abdominal surgery (except history of laparoscopic cholecystectomy) History of gastric surgery (including ESD/EMR for gastric cancer) Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm) History of other malignant diseases within 5 years. Neoadjuvant therapy has been implemented History of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months History of continuous systemic corticosteroid therapy within 1 month Require concomitant surgical treatment for other diseases. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery.
• • Pulmonary function test FEV1 \<50% of the expected value Diffusely invasive gastric cancer Preoperatively confirmed tumor invading the dentate line or duodenum Previous history of iodine allergy Refusal of laparoscopic surgery