Single centre study comparing results of pathologic analysis of EUS-FNA with EUS-TCB in patients with enlarged mediastinal lymph nodes.

Single centre study comparing results of pathologic analysis of EUS-FNA with EUS-TCB in patients with enlarged mediastinal lymph nodes. - EUS-FNA vs EUS-FNA and EUS-TCB

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35501

Enrollment

100

Registered

2011-12-13

Start date

2011-10-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

lymph node enlargement

Interventions

The intervention of this study is to perform trucut biopsy (TCB). There will be performed 4 passes for histologic material. This will be done by using the Quick core endoscopic ultrasound biopsy nee

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with large mediastinal lymph nodes (>2cm) at location Naruke 7 or Naruke 4 Left on CT or PET-CT. Enlarged lymph nodes on EUS more than 2cm. Age 18 and older. ASA classification 1 - 3 Informed consent

Exclusion criteria

Exclusion criteria: ASA classification > 3 Obstructing oral or laryngeal disease. Severe maxillofacial deformity

Design outcomes

Primary

Measure	Time frame
The main study endpoint will be the difference between EUS-FNA alone and EUS-FNA and EUS-TCB.	—

Secondary

Measure	Time frame
The secondary endpoint will be the amount of adverse events seen with the procedure like bleeding and mediastinitis.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)