A phase II study of the safety of laparoscopic distal gastrectomy with D2 lymph node dissection for advanced gastric cancer
Not Applicable
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000032364
- Lead Sponsor
- Tochigi Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
(1) History of upper abdominal surgery. (2) Insufficient oral intake. (3) With active infectious disease requiring systemic treatment. (4) The body temperature of 38 degrees Celsius or higher. (5) Pregnant or possibly pregnant, or lactating female (6) Impossible to register for the study due to a psychological disorder by a physician in charge's decision (7) Under continuous steroids medication (8) With unstable angina pectoris within three weeks or history of myocardial infarction within six months (9) With uncontrollable blood hypertension (10) With uncontrollable diabetes mellitus or routine administration of insulin (11) With pulmonary disease and require continuous oxygen therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of intra-abdominal infectious complications (anastomotic leakage, pancreatic fistula, and intra-abdominal abscess)
- Secondary Outcome Measures
Name Time Method The proportion of conversion to open surgery, and the incidence of adverse events