Evaluation of the Efficacy and Safety of Indocyanine Green Tracing in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer - Trial NCT06421220

Timeline & Enrollment

Primary Outcome

2-year disease free survival rate

Summary

Purpose of the study To evaluate whether the clinical efficacy of submucosal injection of
 indocyanine green tracer laparoscopic gastric cancer lymph node dissection is superior to
 that of laparoscopic gastric cancer lymph node dissection without indocyanine green tracer in
 3D fluorescence laparoscopic mode in patients with gastric adenocarcinoma (cT1-4a, N-/+, M0).
 To observe the role of submucosal injection of ICG for tumor localization in fluorescence 3D
 fluorescence laparoscopic surgery and the application of lymph node dissection in
 laparoscopic radical surgery for gastric cancer.
 
 Study design. Multicenter, randomized, open, parallel-controlled, superiority design.
 Subgroups Group A (experimental group): indocyanine green tracer 3D laparoscopic gastric
 cancer lymph node dissection group Group B (control group): no indocyanine green tracer 3D
 laparoscopic gastric cancer lymph node dissection group.
 
 Study population Patients who met all the inclusion criteria and did not fall into any of the
 exclusion criteria were eligible to enter this study.
 
 Randomization Patients were first evaluated preoperatively to determine that they could
 receive laparoscopic radical gastric cancer treatment and receive endoscopic indocyanine
 green labeling. Once the enrolled cases were determined to meet the admission criteria after
 laparoscopic exploration, they could be enrolled in this study for randomization. The central
 dynamic, stratified zone randomization method was used in this study, and the control factors
 considered were age, tumor site, and preoperative stage. Given the number of seeds and the
 length of the zones, SAS 9.2 programming was applied to generate the treatment allocation
 corresponding to the running number 484, which was deposited in the data center. A person at
 the participating research center was responsible for sending the enrolled case information
 (age, tumor site, and preoperative stage) to the randomization implementation department at
 the data center by email, phone, or SMS, and the contact person at each respective research
 center confirmed that the patient met the enrollment criteria, contacted the contact person
 for the assigned case in this study, and determined the enrollment of the case by further
 analyzing the case information, and at the same time, notified the contact person at the
 research center where the case was located The contact person of the research center where
 the case is located will be notified at the same time. Competitive enrollment was used in
 this study.
 
 Blinding.

ICD-10 Classifications