Study of selective neck dissection navigated by sentinel node biopsy

JRCT ID: jRCT1070240032

Registered date:14/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: T3-4N0,Oral Cancer
• Date of first enrollment: 14/07/2024
• Target sample size: 187
• Study type: Interventional

Intervention(s)

Control group: Selective Neck Dissection
Experimental group: SN-assisted selective neck dissection

Outcome(s)

• Primary Outcome: 3-year neck recurrence-free survival rate
• Secondary Outcome: 3-year crude survival rate, 3-year recurrence-free survival rate, postoperative dysfunction of neck dissection, SN false negative rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1) Patients with T3-4 oral squamous cell carcinoma without lymph node metastasis 2) Patients with no previous treatment for head and neck cancer 3) Patients who are at least 18 years old at the time of consent 4) Patients with written consent from the patient.
• Exclude criteria: 1) Cases with PORT indication (extracapsular invasion, multiple cervical metastases) 2) Cases previously treated with cervical radiation 3) Pregnant or suspected pregnant 4) Cases with serious complications that do not tolerate radical surgery in the judgment of the attending physician 5) Cases deemed inappropriate for this study by the treating physician for other reasons

Related Information

• Primary Sponsor: Hirakawa Hitoshi