FindTrial
Sign In

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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49436
Enrollment
10
Registered
2021-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal cancer Laryngeal carcinoma

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Applicability of the used technique and diagnostic accuracy (sensitivity, specificity, positive and negative predictive value and diagnostic accuracy) for detection of SLN will be calculated by using histopathological results as gold standard.—

Secondary

MeasureTime frame
We want to analyse the difference in BD spreading in primary TL and salvage TL for detection of SLN by using histopathological results as gold standard.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)