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

Fujian Medical University

Status and phase: Enrolling; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Indocyanine Green Tracer

Study type: Interventional

Funder types: Other

Identifiers

NCT05618821

FUGES-027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

ICG

Experimental group

Description:

Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)

Treatment:

Drug: Indocyanine Green Tracer

Non-ICG

Active Comparator group

Description:

Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)

Treatment:

Drug: Indocyanine Green Tracer