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

Gastric Cancer Clinical Trial

Official title:

Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04611997
• Other study ID #: FUGES-020
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 16, 2020
• Est. completion date: October 1, 2026

Study information

• Verified date: September 2023
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Lymph Node Metastases
• Lymphatic Metastasis
• Stomach Neoplasms

Intervention

Drug:
• Indocyanine Green
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant

Locations

Country	Name	City	State
China	Chang-ming Huang	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	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.	3 years
Secondary	Total number of retrieved lymph nodes	Total number of retrieved lymph nodes	30 days