3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Research purpose: 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. Research design: Prospective, single-center, randomized controlled, open-control, parallel assignment, superiority test. 2.1 Case group Group A (Study Group 1, 234 cases): ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group B (Study Group 2, 234 cases): ICG near-infrared imaging tracing in ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group C (Control Group 2, 234 cases) 3D laparoscopic gastrectomy with lymph node dissection 2.2 Estimate Sample Size The three-year disease-free survival (DFS) was the main effectiveness evaluation index in this study. The study implemented a superiority test (unilateral), assuming that both the study group's three-year DFS would be better than that of control group, according to previous research results of laparoscopic surgery for locally advanced GC in which the three-year DFS was 65.2%; therefore, the 3-year DFS of the control group would be 65.2%, assuming that the 3-year DFS of the experimental group could be increased by 12% to 77.2%. With an inspection level 0.0125 (unilateral) and an inspection efficiency of 0.8 and using PASS 11 log-rank tests (Lakatos) [Proportion surviving] the calculated sample size was N=211; namely, each group needed 211 people, considering cases of possible exclusion and loss to follow-up (10% drop out rate). The final sample size for each group was 234 cases, for a total of 702 cases. 2.3 randomization After laparoscopic exploration and confirmation that the cases complied with the standards, they were included in the randomized groups in this study. SAS 9.2 was used to produce a serial number ranging from 0001 - 702 corresponding to the treatment allocation, which was reserved in the data center and research center. 2.4 Blinding Method: This research adopts an open design. 2.5 Research cycle: Estimated enrollment cycle: complete enrollment within 2 years. Follow-up period: the enrollment of the first case was the starting point for follow-up. And the enrollment of last case to the postoperative pathology report (generally 2 weeks after surgery) was the endpoint of follow-up for secondary outcomes. Three years after the last case was enrolled was the follow-up endpoint for the main outcomes. Estimated time: 2023.12-2025.12 (complete enrollment) to 2028.12 (complete follow-up) Study Objects All patients who meet the inclusion criteria and do not conform to the exclusion criteria are qualified for this study.

Official Title
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Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer

Conditions
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Gastric Cancer, Surgery

Intervention / Treatment
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* Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent Exclusion Criteria: 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) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging Other malignant disease within the past 5 years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement for simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)<50% of predicted values Diffuse invasive gastric cancer History of an iodine allergy Patients who declined laparoscopic surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-4K-ICG<br>Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection | Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection<br>* Indocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer<br>|
| Experimental: 4K-ICG<br>Indocyanine Green Tracer Using in Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection | Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection<br>* Indocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer<br>|
| Placebo Comparator: 3D<br>3D Laparoscopic Gastrectomy with Lymph Node Dissection | Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection<br>* Indocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | Disease-free survival is calculated from the day of surgery to the day of recurrence or death | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Operation time | 1 day | 
| Total number of retrieved lymph nodes | Total number of retrieved lymph nodes | 1 day | 
| Noncompliance rate of lymph node dissection | Noncompliance rate of lymph node dissection | 1 day | 
| 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 | 1 day | 
| Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate) | Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate) | 1 day | 
| Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate) | Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate) | 1 day | 
| Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate) | Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate) | 1 day | 
| Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate) | Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate) | 1 day | 
| Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B | Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B | 1 day | 
| Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate) | Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate) | 1 day | 
| Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate) | Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate) | 1 day | 
| Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate) | Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate) | 1 day | 
| Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate) | Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate) | 1 day | 
| Number of metastatic lymph nodes | Number of metastatic lymph nodes | 1 day | 
| Metastasis rate of lymph nodes | Metastasis rate of lymph nodes | 1 day | 
| Morbidity and mortality rates | Morbidity and mortality rates | 30 day | 
| 3-year overall survival rate | 3-year overall survival rate | 3 years | 
| 3-year recurrence pattern | 3-year recurrence pattern | 3 years | 
| Postoperative recovery course | Postoperative recovery course | 30 days | 
| Intraoperative situation | Intraoperative situation | 30 days | 
| Postoperative nutritional status | Postoperative nutritional status | 3 years | 
| Inflammatory and immune response | Inflammatory and immune response | 30 days | 
| Postoperative quality of life (measured by EQ-5D) | Postoperative quality of life (measured by EQ-5D) | preoperative, postoperative 1 month and postoperative 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine Green Tracer, Laparoscopic Gastrectomy, Gastric Cancer, Ultra High Resolution, 3D