A randomized controlled trial of neck dissections based on sentinel lymph node navigation versus standard selective neck dissections in N0 oral cancers

A randomized controlled trial of neck dissections based on sentinel lymph node navigation versus standard selective neck dissections in N0 oral cancers - RCT of sentinel lymph node navigation surgery in oral cancers

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006510

Enrollment

256

Registered

2011-10-17

Start date

2011-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer

Interventions

Selective neck dissections based on sentinel lymph node navigation Standard selective neck dissections

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Previously untreated and clinically negative neck oral squamous cell carcinoma patients (late T1 and T3) are the candidates for our study.

Exclusion criteria

Exclusion criteria: 1)Previously treated patients 2)A history of radiation therapy for the neck 3)Pregnancy or lactating women, or women with suspected pregnancy 4)Patients judged by the investigator to be unfit to be enrolled into the study

Design outcomes

Primary

Measure	Time frame
3 years overall survival	—

Secondary

Measure	Time frame
1)postoperative functional disability and complication of neck 2)3 years disease free survival 3)contralateral neck recurrence and false negative rate 4)accuracy of detecting of sentinel nodes and intraoperative diagnoses of their status	—

Countries

Japan

Contacts

Public ContactYasuhisa Hasegawa

Aichi Cancer Center Department of Head and Neck Surgery

hasegawa@aichi-cc.jp052-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026