3D laparoscopic surgery using a special imaging technique for gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety, efficacy, and feasibility of using Indocyanine Green (ICG) near-infrared imaging during 3D ultra high resolution laparoscopic gastrectomy with lymph node dissection for patients with locally advanced gastric adenocarcinoma. The study involves a prospective, single-center, randomized controlled design with three groups: one receiving the ICG imaging with 3D laparoscopic surgery, another receiving ICG imaging without 3D, and a control group undergoing standard 3D laparoscopic surgery. The primary outcome measure is the three-year disease-free survival rate, aiming to determine if the experimental groups show improved outcomes compared to the control group.

Why it matters

Who can join: the full rules

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. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
4. No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs 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)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging
6. Other malignant disease within the past 5 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 for simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. FEV1 (forced expiratory volume in one second)\<50% of predicted values
14. Diffuse invasive gastric cancer
15. History of an iodine allergy
16. Patients who declined laparoscopic surgery

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Chang-ming Huang — Fujian Medical University Union Hospital
• Study coordinator: Mi Lin
• Email: silihuala@qq.com
• Phone: 13459152658

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.