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Patent blue in laryngeal cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27148
Enrollment
10
Registered
2020-09-16
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

laryngeal cancer, sentinel lymph node

Interventions

By using a standard injection needle via the working channel of a CE-marked routinely used flexible laryngoscope, 0.5-1 ml PB will be injected around laryngeal tumor tissue at the beginning of a routi

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

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 - hypersensitivity for patent blue

Design outcomes

Primary

MeasureTime frame
After ex vivo confirmation that PB injected around LC in a laryngeal surgical specimen is not spreading into tissues beyond the tumor, the detection of SLN by a technique of injecting PB via a flexible laryngoscope using a working channel has to be tested.

Secondary

MeasureTime frame
We want to analyze the difference in PB spreading for detection of SLN in primary TL and salvage TL.

Contacts

Public ContactConstanze Scholman

Universitair Medisch Centrum Groningen

c.scholman@umcg.nl(050) 361 61 61

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)