Standardization of neck dissection procedures for hypopharyngeal and supraglottic carcinomas

UMIN ID: UMIN000002004

Registered date:28/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hypopharyngeal carcinoma, supraglottic carcinoma
• Date of first enrollment: 2009/06/01
• Target sample size: 198
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Neck dissection. This protocol proposes "Recommendations for the extent of neck lymph node resection" for each N-stage and side of operation (ipsilateral or contralateral) and "Recommendations for the surgical maneuvers" for 4 key details of neck dissection.

Outcome(s)

• Primary Outcome: 2-year neck control rate
• Secondary Outcome: 1. Percentage of patients in whom the surgeon accepted "Recommendations for the extent of neck lymph node resection" 2. Percentage of patients where the surgeon accepted "Recommendations for surgical maneuvers for 4 key details of neck dissection" 3. 2-year overall survival rate, 2-year cause-specific survival rate

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with distant metastasis 2) Patients who underwent neck dissection in the past 3) Patients with a simultaneous secondary carcinoma which requires neck dissection 4) Patients with recurrent cancer

Related Information

• Primary Sponsor: The Japan Neck Dissection Study Group (JNDSG)
• Secondary Sponsor: none
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare, JAPAN,none