To evaluate the feasibility and potential of sentinel node biopsy in patients with (recurrences of) laryngeal carcinomas and clinically negative neck undergoing total laryngectomy and neck dissection.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint the feasibility and validation of sentinel node biopsy
procedure in patients with (recurrences of) laryngeal carcinomas scheduled for
total laryngectomy.
Secondary outcome
NA
Background summary
In patients with laryngeal carcinoma and a clinically negative neck treated by
laryngectomy a substantial number of futile neck dissections is performed in
clinical practice. Intraoperative identification and histopathological
examination of the sentinel node may be used to select patients for neck
dissection and reduce the number of futile neck dissections.
Study objective
To evaluate the feasibility and potential of sentinel node biopsy in patients
with (recurrences of) laryngeal carcinomas and clinically negative neck
undergoing total laryngectomy and neck dissection.
Study design
This is an observational non-randomized pilot study.
During general anesthesia for laryngectomy and neck dissection peritumoral
injections of radiolabeled-colloid, intraoperative identification of the
sentinel node(s) using a hand held gamma probe and surgical excision of the
sentinel lymph node(s) 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 exploration of the neck for
laryngectomy and neck dissection.
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
Patients scheduled for laryngectomy and (selective) neck dissection for (advanced or recurrent) laryngeal carcinoma
Primary tumor accessible for peritumoral injection of radiolabeled colloid on direct laryngoscopy
No lymph node metastases on CT, MRI or ultrasound guided fine needle aspiration cytology
Exclusion criteria
Clinical lymph node metastases
Tumor not accessible for endoscopic injection
age > 80 jaar
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 | NL22938.029.08 |