Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

Fujian Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Early Gastric Cancer; Indocyanine Green; Lymph Node Dissection

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT04973475

FUGES-023

Details and patient eligibility

About

This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.

Full description

After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
5. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
7. American Society of Anesthesiology score (ASA) class I, II, or III
8. Written informed consent

Exclusion criteria

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
6. History of other malignant disease within past five 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 of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. Forced expiratory volume in 1 second (FEV1)<50% of predicted values
14. Rejection of laparoscopic resection
15. Preoperatively confirmed tumors invading the dentate line or duodenum
16. History of allergy to iodine agents
17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

180 participants in 1 patient group

Experimental: Indocyanine Green Tracer

Experimental group

Description:

Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma.

Treatment:

Drug: Indocyanine Green