Primary Objective: The primary objective is to investigate whether EUS-TCB had an added value on EUS-FNA alone. Secondary Objective(s): The secondary objective is to study whether EUS-TCB does not have a higher complication rate than EUS-FNA alone…
ID
Source
Brief title
Condition
- Lymphomas NEC
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be the difference between EUS-FNA alone and
EUS-FNA and EUS-TCB.
Secondary outcome
The secondary endpoint will be the amount of adverse events seen with the
procedure like bleeding and mediastinitis.
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. Lymph nodes are easily accessed with this method at
locations near the oesophagus. Locations high paraoesophageal (Naruke 2),
aorto-pulmonary window (Naruke N4L), subcarinal (N7) and low paraoesophageal
(Naruke 8 and 9) can be reached.
EUS-FNA has a sensitivity of 88-96% and a specificity of almost 100% and an
accuracy of 95%.
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.
In mediastinal lesions too EUS-TCB is an accurate method. There is a diagnostic
accuracy of 90% and in combination with EUS-FNA 98%. EUS-TCB is as safe as
EUS-FNA when used in the stomach, with a complication rate of 2%.
However limitations of these studies are that they were retrospective studies.
Therefore a prospective study has to be performed to see if EUS-TCB has an
added value to EUS-FNA alone.
Study objective
Primary Objective: The primary objective is to investigate whether EUS-TCB had
an added value on EUS-FNA alone.
Secondary Objective(s): The secondary objective is to study whether EUS-TCB
does not have a higher complication rate than EUS-FNA alone.
Study design
A single centre prospective accuracy study will be performed.
The study will be carried out between October 2011 and May 2012.
All patients who have to undergo an EUS-FNA and have lymph nodes larger than
20mm on CT will be asked to undergo EUS-TCB also. When lymph nodes are also
larger than 20mm at ultrasound too, EUS-TCB can be performed.
During EUS the complications will be scored.
The pathologist will try to give a diagnosis on the EUS-FNA alone and on
EUS-TCB alone.
Intervention
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 needle of 19 GA (Cook Ireland Ltd).
Study burden and risks
There seems to be no increased risk compared to standard procedure in previous
investigation. The increase in time for the patient in the study, takes about 5
minutes.
There propably can be given a better diagnose on the lymph node enlargement due
to histologic biopsies.
Groot Wezenland 20
8011 JWM Zwolle
NL
Groot Wezenland 20
8011 JWM Zwolle
NL
Listed location countries
Age
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
ASA classification > 3
Obstructing oral or laryngeal disease.
Severe maxillofacial deformity
Design
Recruitment
Medical products/devices used
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 | NL38098.075.11 |