A phase II study of laparoscopy assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0703)

UMIN ID: UMIN000000874

Registered date:01/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: clinical stage I gastric cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 170
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Laparoscopy assisted distal gastrectomy

Outcome(s)

• Primary Outcome: Incidence of anastomotic leakage or pancreatic fistula
• Secondary Outcome: overall survival, recurrence-free survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Women during pregnancy or breast-feeding. 3) Severe mental disease. 4) Continuous systemic steroid therapy. 5) History of myocardial infarction or unstable angina pectoris within six months. 6) Uncontrollable hypertension. 7) Uncontrollable diabetes millutus or administration of insulin. 8) Severe respiratory disease requiring continuous oxygen therapy.

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare