Evaluation and comparison of sentinel node biopsy (SNB) and ultrasound guided fine needle aspiration cytology (USgFNAC) in the management of the clinically negative neck in patients planned for transoral excision of oral and oropharyngeal squamous…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of selection for treatment of the neck by strategies based
on USgFNAC and/or SNB.
Secondary outcome
Number of neck dissections, quality of life, patients* perspective and
cost-effectiveness of selection strategies based on USgFNAC and/or SNB or
elective treatment of the neck.
Background summary
The treatment of the clinically negative neck (N0) in small oral or
oropharyngeal carcinoma is controversial. When there is a low likelihood of
occult (clinically undetectable) lymph node metastases, is the choice between
elective neck dissection or a wait and see policy. Because of the risk of over-
and undertreatment there is need for a reliable diagnostic technique.
Ultrasound guided fine needle aspiration cytology (USgFNAC) is routinely used
in the detection of lymph node metastases. The sentinel node procedure is a
promising technique which is nowadays routinely used in other tumor types.
Study objective
Evaluation and comparison of sentinel node biopsy (SNB) and ultrasound guided
fine needle aspiration cytology (USgFNAC) in the management of the clinically
negative neck in patients planned for transoral excision of oral and
oropharyngeal squamous cell carcinoma.
Study design
Prospective, observational study of 60 patients to define accuracy of either
technique in a head-to-head comparison, and to model the cost effectiveness of
USgFNAC and/or SNB-based diagnosis-therapy combinations.
The volume and direct medical costs of treatment and follow-up will be
extracted from hospital databases and patient files. A model will evaluate the
costs and effects of possible diagnostic and treatment strategies in this
patient group.
Study burden and risks
Sentinel node procedure and ultrasound guided fine needle aspiration cytology
are used routinely in several tumor types. In the literature on head and neck
cancer no serious adverse events have been reported using these diagnostic
techniques. The diagnostic techniques will be performed by experienced head and
neck surgeons, nuclear physicians, radiologists and pathologists.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients with a primary biopsy proven oral/oropharyngeal squamous cell carcinoma which can be locally (transorally) resected and a clinically negative neck.
Exclusion criteria
Transoral excision not possible
Neck entered for reconstruction
Clinical lymph node metastasis
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 |
---|---|
CCMO | NL19558.029.07 |