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

• Sponsor: Fujian Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04611997
• Collaborator: (none)
• Enrollment: 240
• Arms: 2
• Anticipated Duration (Months): 71

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer; Lymph Node Metastases	Procedure: Indocyanine Green Tracer Using in Laparoscopic Gastrectomy	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group A (Study Group): Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group) Group B (Control Group): Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)Group A (Study Group): Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group) Group B (Control Group): Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy
• Anticipated Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group)	Procedure: Indocyanine Green Tracer Using in Laparoscopic Gastrectomy; Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant
Placebo Comparator: Group B Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)	Procedure: Indocyanine Green Tracer Using in Laparoscopic Gastrectomy; Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant

Outcome Measures

Primary Outcome Measures

1. 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

1. Total number of retrieved lymph nodes [30 days]

   Total number of retrieved lymph nodes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang-Ming Huang, Prof., Professor, Fujian Medical University
• ClinicalTrials.gov Identifier: NCT04611997
• Other Study ID Numbers: FUGES-020
• First Posted: Nov 2, 2020
• Last Update Posted: Nov 2, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms; Lymphatic Metastasis

Study Results

No Results Posted as of Nov 2, 2020