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โ† Trials
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3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer

RecruitingPhase 3Ages 18 Years - 75 YearsAllFujian Medical University
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In plain words

What the trial is, and whether it could suit you

Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
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Where

1 site
Fujian Medical University Union Hospital
Fuzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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