A randomized phase II study for reconstruction after distal gastrctomy (Billroth I versus Roux-en-Y method)

UMIN ID: UMIN000000878

Registered date:05/11/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Curative distal gastrectomy for gastric cancers
• Date of first enrollment: 2005/08/01
• Target sample size: 320
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Billroth-I method
Roux-en-Y method

Outcome(s)

• Primary Outcome: body weight loss rate at one year afer surgery
• Secondary Outcome: incidence of delayed gastric empty, reflux esphagitis and surgical complication

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: Clinical surgery research group/The supporting center for clinilcal and education
• Source(s) of Monetary Support: none(self funding)