Detection of sentinel lymph nodes in laryngeal cancer by injection of patent blue dye via flexible laryngoscopy as a new technique

Recruiting

• Conditions: Laryngeal cancer; Laryngeal carcinoma; 10027655

• Registration Number: NL-OMON49436
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- proven carcinoma of the larynx
- > 18 yrs of age
- undergo a total laryngectomy with planned neck dissection.
- informed consent

Exclusion Criteria

- partial laryngectomy
- no planned neck dissection
- pregnancy
- earlier hypersensitivity reaction to BD or to trifenylmethan pigment (which
is used in cosmetics or food)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Applicability of the used technique and diagnostic accuracy (sensitivity,<br /><br>specificity, positive and negative predictive value and diagnostic accuracy)<br /><br>for detection of SLN will be calculated by using histopathological results as<br /><br>gold standard.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We want to analyse the difference in BD spreading in primary TL and salvage TL<br /><br>for detection of SLN by using histopathological results as gold standard. </p><br>