Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer
Not Applicable
Completed
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000018377
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of severe drug hypersensitivity 2) history of another malignancy within 5 years 3) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure. 4) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy 5) Physician concludes that the patient's participation in this trial is inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of sentinel node metastases
- Secondary Outcome Measures
Name Time Method 1)Sensitivity 2)Specificity 3)Positive Predictive Value(PPV) 4)Negative Predictive Value(NPV) 5)Detection rate 6)Adverse event rate