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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Surgery
• Intervention / Treatment: Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection

Detailed Description

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Estimated): 702
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mi Lin; Phone Number: 13459152658; Email: silihuala@qq.com
• Study Contact Backup: Name: Hua-Long Zheng; Phone Number: 18359190587; Email: 291167038@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
4. No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging
6. Other malignant disease within the past 5 years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within past six months
9. History of cerebrovascular accident within past six months
10. History of continuous systematic administration of corticosteroids within one month
11. Requirement for simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. FEV1 (forced expiratory volume in one second)<50% of predicted values
14. Diffuse invasive gastric cancer
15. History of an iodine allergy
16. Patients who declined laparoscopic surgery

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
3-year overall survival rate	3-year overall survival rate	3 years
3-year recurrence pattern	3-year recurrence pattern	3 years
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
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

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Chang-Ming Huang, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Gastric Cancer; Indocyanine Green Tracer; Laparoscopic Gastrectomy; 3D; Ultra High Resolution
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUGES-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No