To compare the feasibility of mutation analysis in samples obtained with EUS-FNA and EUS-TCB in patients with mediastinal lymph node metastasis in NSCLC. To compare EUS-TCB with EUS-FNA in diagnosing benign and malignant mediastinal disease.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pathologic diagnosis; mutation analysis in NSCLC
Secondary outcome
Complications
Background summary
Endoscopic ultrasound guided fine-needle aspiration is a widely used diagnostic
tool in the analysis and staging of lung cancer and mediastinal lymphadenopathy
in other diseases.
EUS-FNA has a sensitivity of 88-96% and a specificity of almost 100% and
accuracy of 95%1, 2 .
In the gastroenterology trucut biopsy (EUS-TCB) is a proven diagnostic tool in
the evaluation of benign and malignant disease, as well as in staging malignant
tumours of the gastrointestinal tract 3.
In mediastinal lesions too EUS-TCB is an accurate method. There is a diagnostic
accuracy of 98% in combination with EUS-FNA 4.
Molecular analysis for EGFR and KRAS mutations evolved to increasing relevance
and is rapidly developing to standard practice in stage IV NSCLC5. Most
mutation analysis has been done on histologic samples, however more and more
studies report on molecular diagnostics on cytological material too (using High
resolution melting6), it is not clear if this method has a better specificity
and sensitivity than mutation analysis on histological material.
In this study the pathologic results of histologic and cytologic samples of
mediastinal lymph nodes obtained with EUS-TCB respectively EUS-FNA are compared
in order to evaluate the added value of histology in the diagnosis of malignant
and benign mediastinal disease.
Moreover the feasibility of molecular analysis in EUS-TCB and EUS-FNA derived
samples is compared for patients with a diagnosis of NSCLC.
We also want to score the complication rate. In the gastroenterology a
complication rate of 2% is described in EUS-FNA as in EUS-TCB (infection and
bleeding)7.
Study objective
To compare the feasibility of mutation analysis in samples obtained with
EUS-FNA and EUS-TCB in patients with mediastinal lymph node metastasis in
NSCLC.
To compare EUS-TCB with EUS-FNA in diagnosing benign and malignant mediastinal
disease.
Study design
Prospective, open, single-arm, single-centre trial
Study burden and risks
Little additional load (the test takes around 5minuten longer) plus additional
punctures, which are generally not felt.
Groot Wezenland 20
8000 GM Zwolle
Nederland
Groot Wezenland 20
8000 GM Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
1. Patients with large mediastinal lymph nodes (>2cm) at location N7, N4L on CT or PET-CT.
2. Age of 18-85 years.
3. ASA classification 1 - 3
Exclusion criteria
1. ASA classification > 3 (see appendix A)
2. Obstructing oral or laryngeal disease.
3. Severe maxillofacial deformity.
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 | NL36627.075.11 |