No registrations found.
ID
Source
Brief title
Health condition
1. Head and neck cancer;
2. Lymph node metastases;
3. Sentinel node biopsy;
4. Ultrasound guided fine needle aspiration cytology;
5. Neck dissection;
6. Costs;
7. Quality of life.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Evaluation and comparison of sentinel node biopsy and ultrasound guided fine needle aspiration cytology in the management of the clinically negative neck in patients planned for transoral excision of oral and oropharyngeal squamous cell carcinoma.
Study objective
Application of sentinel node biopsy (in comparison to or combined with ultrasound guided fine needle aspiration cytology) improves the detection of occult lymph node metastases to a clinically relevant extent.
Intervention
Each patient will ondergo ultrasound guided fine needle aspiration cytology (standard procedure) and sentinel node biopsy procedure.
Boelelaan 1117
R. Bree, de
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443690
r.bree@vumc.nl
Boelelaan 1117
R. Bree, de
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443690
r.bree@vumc.nl
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
1. Transoral excision not possible;
2. Neck entered for reconstruction;
3. Clinical lymph node metastasis;
4. Age < 18 or > 80 year.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1025 |
| NTR-old | NTR1057 |
| Other | VUmc : 2007/190 (projectnumber VUmc) |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |