Detection of sentinel lymph node using contrast-enhanced ultrasonography
- Conditions
- Oropharyngeal cancer
- Registration Number
- JPRN-jRCTs041180019
- Lead Sponsor
- WAKISAKA Naohiro
- Brief Summary
1) In the previous report, the sentinel lymph node metastasis-positive ratio were about 20%. However, in this study, the ratio was 0%. 2) We could not tconfirm that the resected lymph node was actual sentinel lymph node. Therefore, we judged that picking-up of sentinel lymph node was difficult in our method. Thus we stopped this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 4
1) Patients of oropharyngeal cancer with clinical cN0 disease using neck computed tomography 2) Patients without the histories of previous treatment for oropharyngeal cancer 3) Age, at the time of the consent, is 18 years or older 4) The patient with a documented informed consent for the participation to this study from their own free will
1) The patient who had recurrent disease of oral cancer 2) The case with a history of irradiation to the neck 3) The patient who had previous treatment such as chemotherapy and/or irradiation before surgery 4) Allergic history for Sonazoid or Indigo carmine 5) Allergic history for egg 6) A woman with possibility of the pregnancy or the intention, a pregnant woman or lactation 7) The patient in whom a principle investigator or members judged to be inappropriate as a subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event until the day of surgery<br>Detection rate of sentinel lymph node wit contrast-enhanced ultrasonography
- Secondary Outcome Measures
Name Time Method Sensitivity, specificity, negative-predictive ratio, positive-predictive ratio, accuracy, and false-negative ratio of of detected SN for metastases <br>Number of cetected vasculature, and its relation with metastases <br>Recurrence-free Survival