Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection

• Status: Recruiting
• Trial end date: 2023-10-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphadenectomy for patients with gastric cancer was different. The patients with gastric adenocarcinoma (cT1-4a, N0/+, M0) were studied.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University

Criteria

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 T1-4a (cT1-4a), 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. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)

6. American Society of Anesthesiology score (ASA) class I, II, or 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 laparoscopic cholecystectomy)

4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection

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 past six months

11. History of cerebrovascular accident within past six months

12. History of continuous systematic administration of corticosteroids within one month

13. Requirement of simultaneous surgery for other disease

14. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

15. Forced expiratory volume in 1 second (FEV1)<50% of predicted values

16. Linitis plastica, Widespread