Clinical trial NCT06161207: 3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Surgery
Keywords: Indocyanine Green Tracer
Laparoscopic Gastrectomy
Gastric Cancer
Ultra High Resolution
3D
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Operation time
timeFrame: 1 day
measure: Total number of retrieved lymph nodes
timeFrame: 1 day
measure: Noncompliance rate of lymph node dissection
timeFrame: 1 day
measure: Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
timeFrame: 1 day
measure: Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
timeFrame: 1 day
measure: Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
timeFrame: 1 day
measure: Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)
timeFrame: 1 day
measure: Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)
timeFrame: 1 day
measure: Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B
timeFrame: 1 day
measure: Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)
timeFrame: 1 day
measure: Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)
timeFrame: 1 day
measure: Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)
timeFrame: 1 day
measure: Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)
timeFrame: 1 day
measure: Number of metastatic lymph nodes
timeFrame: 1 day
measure: Metastasis rate of lymph nodes
timeFrame: 1 day
measure: Morbidity and mortality rates
timeFrame: 30 day
measure: 3-year overall survival rate
timeFrame: 3 years
measure: 3-year recurrence pattern
timeFrame: 3 years
measure: Postoperative recovery course
timeFrame: 30 days
measure: Intraoperative situation
timeFrame: 30 days
measure: Postoperative nutritional status
timeFrame: 3 years
measure: Inflammatory and immune response
timeFrame: 30 days
measure: Postoperative quality of life (measured by EQ-5D)
timeFrame: preoperative, postoperative 1 month and postoperative 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-ming Huang
role: PRINCIPAL_INVESTIGATOR
References: