Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Phase 2

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: Indocyanine Green Tracer

• Registration Number: NCT05618821
• Lead Sponsor: Fujian Medical University

Brief Summary

Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.

Detailed Description

Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

Study Timeline

• Study Start: 2022-06-03
• Study First Submitted: 2022-06-03
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-16
• Last Update Posted: 2022-11-16
• Primary Completion: 2025-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Age from 18 to 75 years
2. Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)

(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby 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) class 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 and gastrectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Rejection of laparoscopic resection
6. History of allergy to iodine agents
7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
8. History of other malignant disease within past five years
9. History of previous neoadjuvant chemotherapy or radiotherapy
10. History of unstable angina or myocardial infarction within the past six months
11. History of unstable angina or myocardial infarction within past six months
12. History of continuous systematic administration of corticosteroids within one month
13. Requirement of simultaneous surgery for another disease
14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
15. FEV1<50% of the predicted values
16. Linitis plastica, Widespread

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total Number of Retrieved Lymph Nodes	30 days	Total Number of Retrieved Lymph Nodes

Secondary Outcome Measures

Name	Time	Method
Postoperative recovery course	30 days	Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
Lymph node noncompliance rate	30 days	Lymph node noncompliance rate
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group	30 days	Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)	30 days	Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)	30 days	Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Number of Metastasis Lymph Nodes	30 days	Number of Metastasis Lymph Nodes
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)	30 days	Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Metastasis rate of lymph node	30 days	Metastasis rate of lymph node
3-year disease-free survival rate	3 years	3-year disease-free survival rate
Postoperative morbidity rate	30 days	Postoperative morbidity rate
Postoperative mortality rate	30 days	Postoperative mortality rate
3-year overall survival rate	3 years	3-year overall survival rate
3-year recurrence pattern	3 years	3-year recurrence pattern
Intraoperative situation	30 days	Operation time, intraoperative blood loss, and intraoperative morbidity rate

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China