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

Gastric Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms
• Surgery

• NCT number: NCT06161207
• Study type: Interventional
• Source: Fujian Medical University
• Contact: Mi Lin
• Phone: 13459152658
• Email: silihuala@qq.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2024
• Completion date: January 1, 2029