Clinical trial: Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer (NCT03290209)

Eligibility criteria:
Inclusion Criteria:

          1. Age over or equal to 75 years

          2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
             poorly differentiated) confirmed pathologically by endoscopic biopsy, including
             gastric multiple primary carcinoma

          3. cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the
             American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition

          4. expected to perform distal, total or proximal gastrectomy to obtain R0 resection
             sugicall results.

          5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale

          6. ASA (American Society of Anesthesiology) class I to III

          7. Written informed consent

        Exclusion Criteria:

          1. Severe mental disorder

          2. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

          3. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal
             Dissection/Endoscopic Mucosal Resection )for gastric cancer)

          4. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
             imaging

          5. History of other malignant disease within the past 5 years

          6. History of previous neoadjuvant chemotherapy or radiotherapy

          7. History of unstable angina or myocardial infarction within the past 6 months

          8. History of cerebrovascular accident within the past 6 months

          9. History of continuous systematic administration of corticosteroids within 1 month

         10. Requirement of simultaneous surgery for other disease

         11. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
             gastric cancer

         12. FEV1<50% of the predicted values
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 75 Years old.


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? Contradiction