3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University
About this trial
Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 75 years
Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
Disqualifiers
Women during pregnancy or breast-feeding
Severe mental disorder
History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
History of previous gastric surgery (including ESD/EMR for gastric cancer)
Trial design
Design model
Parallel
Treatments tested in this trial
Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
Procedure/SurgeryIndocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer
Treatment groups
702 Participants
are divided into 3 treatment groupsGroup A: 3D-4K-ICGExperimental treatment 1 intervention
Group B: 4K-ICGExperimental treatment 1 intervention
Group C: 3DPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-year disease free survival rate
Disease-free survival is calculated from the day of surgery to the day of recurrence or death
Time frame
3 yearsSecondary outcomes
1
Operation time
Operation time
Time frame
1 day2
Total number of retrieved lymph nodes
Total number of retrieved lymph nodes
Time frame
1 day3
Noncompliance rate of lymph node dissection
Noncompliance rate of lymph node dissection
Time frame
1 day4
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Fujian Medical University
Lead sponsor
Fujian Medical University Union Hospital
Sponsor institution
Source ClinicalTrials.gov