Ultrasound guided fine needle aspiration cytology and sentinel node biopsy in the detection of occult lymph node metastases of early oral and oropharyngeal cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26273

Enrollment

Registered

2007-09-24

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

1. Head and neck cancer

Interventions

Each patient will ondergo ultrasound guided fine needle aspiration cytology (standard procedure) and sentinel node biopsy procedure.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with a primary biopsy proven oral/oropharyngeal squamous cell carcinoma; 2. Planned for transoral excision; 3. Without clinically suspected cervical lymph nodes.

Exclusion criteria

Exclusion criteria: 1. Transoral excision not possible; 2. Neck entered for reconstruction; 3. Clinical lymph node metastasis; 4. Age 80 year.

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of selection for treatment of the neck by strategies based on ultrasound guided fine needle aspiration cytology and/or sentinel node biopsy.	—

Secondary

Measure	Time frame
number of neck dissections, quality of life, patient's perspective, cost-effectiveness of selection strategies based on ultrasound fine needle aspiration cytology and/or sentinel node biopsy or elective treatment of the neck.	—

Contacts

Public ContactR. Bree, de

VU University Medical Center, Department of Otolaryngology /Head and Neck Surgery, Boelelaan 1117

r.bree@vumc.nl+31 (0)20 4443690

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)