Clinical trial: Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer (NCT03007550)

Eligibility criteria:
Inclusion Criteria:

          1. Aged 18-75 years；

          2. Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as
             papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly
             cohesive carcinoma (including signet ring cell carcinoma and other variants), and
             mixed adenocarcinoma;

          3. Clinical stage IA (T1N0M0) or IB (T1N1M0, T2N0M0) (According to AJCC-7th TNM staging
             system);

          4. Tumor located in the upper or middle third of the stomach, and curative resection is
             expected to be achievable by total gastrectomy with D1+/D2-10 lymphadenectomy (also
             apply to multiple primary cancers);

          5. No invasion to Z-line;

          6. BMI (Body Mass Index) < 30 kg/m2;

          7. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);

          8. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy,
             etc.;

          9. No enlargement of splenic hilar lymph nodes;

         10. Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1;

         11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III;

         12. Sufficient organ functions;

         13. Written informed consent.

        Exclusion Criteria:

          1. Preoperative examinations indicate that the stage of the disease is stage II/III/IV;

          2. Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph
             nodes (min diameter≥1.0cm);

          3. Women during pregnancy or breast-feeding;

          4. Synchronous or metachronous (within 5 years) malignancies;

          5. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy
             indicated;

          6. Severe mental disease;

          7. Severe respiratory disease;

          8. Severe hepatic and renal dysfunction;

          9. Unstable angina pectoris or history of myocardial infarction within 6 months;

         10. History of cerebral infarction or cerebral hemorrhage within 6 months;

         11. Continuous systemic steroid therapy within 1 month (except for topical use);

         12. Gastric cancer complications (bleeding, perforation, obstruction) that requiring
             emergency surgery;

         13. Patients are participating or have participated in another clinical trial (within 6
             months).
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? 1