IGG Using in Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Phase 3

Active, not recruiting

• Conditions: Gastric Cancer; Lymph Node Metastases
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT04611997
• Lead Sponsor: Fujian Medical University

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 guiding laparoscopic D2 lymph node dissection for gastric cancer after neoadjuvant chemotherapy by comparing injection ICG group and non-injection ICG group

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-02
• Study Start: 2020-11-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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 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) score 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. Preoperatively, tumors involving the squamocolumnar junction or duodenum were confirmed
16. A history of iodine allergy
17. Refuse laparoscopic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Indocyanine Green	Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group)
Group B	Indocyanine Green	Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)

Primary Outcome Measures

Name	Time	Method
3-year disease free survival rate	3 years	Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.

Secondary Outcome Measures

Name	Time	Method
Total number of retrieved lymph nodes	30 days	Total number of retrieved lymph nodes

Trial Locations

Locations (1)

Chang-ming Huang; 🇨🇳 Fuzhou, Fujian, China