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Needle based CLE in thoracic lymph nodes, a comparison with pathology.

Needle based CLE in thoracic lymph nodes, a comparison with pathology. - Needle based CLE in thoracic lymhp nodes.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43854
Enrollment
20
Registered
2015-08-26
Start date
2016-01-13
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Intrathoracic lymphadenopathy

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - suspected or proved NSCLC, with an indication for EUS-FNA for tissue verification of suspected mediastinal lymph nodes. - Suspected sarcoidosis stage I-II, with an indication of tissue verification of enlarged mediastinal lymph node(s) by EUS-FNA.

Exclusion criteria

Exclusion criteria: - Allergy for fluorescein - Use of Beta blocker on the day of the procedure - (Possible) pregnancy or lactation - Inability to provide informed consent - Inability to comply with study protocol

Design outcomes

Primary

MeasureTime frame
1 To describe characteristics and define interpretation criteria for nCLE imaging of: - normal/reactive lymph nodes - lymph nodes involved in lungcancer - lymph nodes involved in sarcoidosis

Secondary

MeasureTime frame
1. To develop an CLE image atlas for lymph nodes involved in different pulmonal diseases 2.To assess procedure-related events of needle based CLE 3. To assess technical feasibility of needle based CLE

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)