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

Phase 3Active Not RecruitingNCT04611997

Fujian Medical University240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Gastric Cancer Lymph Node Metastases

Interventions

Indocyanine GreenDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chang-ming Huang

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Secondary Outcomes

Total number of retrieved lymph nodes

Time frame: 30 days

Data from ClinicalTrials.gov

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