A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)
- Conditions
- Curative distal gastrectomy for gastric cancers
- Registration Number
- JPRN-UMIN000000878
- Lead Sponsor
- Clinical surgery research group/The supporting center for clinilcal and education
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 320
Not provided
1) History of laparotomy excluding laparoscopic cholecyctectomy and addendectomy (skin incision less than 5cm) 2) Non-curative factors proven by pre-operative examinations 3) Pre-operatiev chemotherapy 4) Synchronous malignancies other than carcinoma in situ of cervical cancer or focal cancer in adenoma of colorectal cancers 5) Metachronous malignancies within 5 years or with tumor recurrence 6) Severe respiratory dysfunction 7) History of myocardial infarction of two-step Master positive by ECG 8) Liver cirrhosis or chronic active hepatitis 9) Chronic renal failure with hemodialysis 10) Uncontrolled diabetes (HbA1C 9.0 or more) 11) Reflux esophagitis (LA grade A or more) 12) Other unfeasible factors to perform study safely, approved by attending surgeon
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method body weight loss rate at one year afer surgery
- Secondary Outcome Measures
Name Time Method incidence of delayed gastric empty, reflux esphagitis and surgical complication