Clinical trial: Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer (NCT02289183)

Eligibility criteria:
Inclusion Criteria:

          -  Age from 18 to 75 years (including 18 and 75 years old)

          -  Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell,
             or poorly differentiated) confirmed pathologically by endoscopic biopsy

          -  cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee
             on Cancer (AJCC) Cancer Staging Manual Seventh Edition

          -  Expected curative resection through distal subtotal gastrectomy with D2
             lymphadenectomy

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

          -  American Society of Anesthesiology score (ASA) class I, II, or III

          -  Written informed consent

        Exclusion Criteria:

          -  Women during pregnancy or breast-feeding

          -  Severe mental disorder

          -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

          -  History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
             dissection

          -  Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

          -  History of other malignant disease within past five years

          -  History of previous neoadjuvant chemotherapy or radiotherapy

          -  History of unstable angina or myocardial infarction within past six months

          -  History of cerebrovascular accident within past six months

          -  History of continuous systematic administration of corticosteroids within one month

          -  Requirement of simultaneous surgery for other disease

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

          -  FEV1<50% of 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 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