Using Indocyanine Green Tracer in Laparoscopic Surgery for Remnant Gastric Cancer

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

This study tests whether using a special dye during laparoscopic surgery can help doctors find cancerous lymph nodes better in patients with remnant gastric cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Medical University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05618821 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of using Indocyanine Green (ICG) Tracer during laparoscopic gastrectomy with lymph node dissection for patients with remnant gastric cancer. The study compares outcomes between patients who receive ICG injections and those who do not, aiming to improve the identification of positive lymph nodes. By analyzing over 300 cases, the trial seeks to establish ICG as a reliable, non-radiative method for guiding surgical procedures in this context.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with resectable remnant gastric cancer and no distant metastasis.

Not a fit: Patients with a history of severe mental disorders, previous upper abdominal surgeries, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance surgical precision and outcomes for patients with remnant gastric cancer.

How similar studies have performed: While the use of ICG in various surgical contexts has shown promise, this specific application in remnant gastric cancer is novel and untested.

Eligibility criteria

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

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Hualong Zheng

Conditions: Gastric Cancer, Indocyanine Green Tracer, Laparoscopic Gastrectomy, Remnant Gastric Cancer