Clinical trial: Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection (NCT04219332)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment