To evaluate the feasibility and prove the concept of sentinel node biopsy in patients with carcinoma of the parotid gland and scheduled for parotidectomy and elective neck dissection.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the feasibility and validation of the sentinel node biopsy
procedure in patients with carcinoma of the parotid gland with N0 neck
scheduled for parotidectomy with elective neck dissection.
Secondary outcome
NA
Background summary
In patients with carcinoma of the parotid gland the management of the
clinically negative neck is a controversial issue. In most patients a selective
(L I-III) neck dissection is performed but a substantial number of them are
futile. The current diagnostic techniques are not accurate enough to detect
occult lymph node metastases. The sentinel node procedure may be useful to
select patients for neck dissection and reduce the number of futile neck
dissections.
Study objective
To evaluate the feasibility and prove the concept of sentinel node biopsy in
patients with carcinoma of the parotid gland and scheduled for parotidectomy
and elective neck dissection.
Study design
This is an observational non-randomized validation study. Patients will undergo
peritumoral injection of radiolabelled-colloid, lymphoscintigraphy, surgical
excision of the sentinel lymph node(s) in the neck and detailed
histopathological examination.
Study burden and risks
Sentinel node biopsy is a procedure which is used routinely in other tumor
types. In the literature on head and neck cancer no serious adverse events have
been reported using these techniques. Sentinel node biopsy will be performed by
experienced head and neck surgeons during surgery of the primary tumor. Neck
dissection in combination with sentinel node biopsy stages the neck more
accurately (by detecting micrometastases and single tumor cells which may be
missed during routine examination of lymph nodes) than neck dissection alone.
Findings from this validation study may have implications for future treatment
planning.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients with carcinoma of the parotid gland
No lymph node metastases on CT, MRI or USgFNAC
Scheduled for parotidectomy and elective (selective or modified radical) neck dissection
Exclusion criteria
Clinical lymph node metastases
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 | NL24715.029.08 |