To determine if EBUS / EUS-B guided nodal/lung tumor sampling with 22 Gauge (G) TBNB (Acquire**) needles results in improved tissue core sample acquisition in comparison to standard 22 G TBNA needles for the diagnosis and staging of lung cancer.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
1. The suitability rate for the assessment of PD-L1 expression on the cell
block preparation with the EBUS/EUS-B 22 G TBNB Boston Acquire** needle vs 22 G
TBNA Boston Scientific standard needle of mediastinal/hilar nodal or tumor
aspirates in patients with a final diagnosis of lung cancer. Cell block
specimens will be considered suitable if more than 100 tumor cells are present
in the specimen.
Secondary outcome
1. Cumulative length tissue core
2. Suitability for molecular analysis/next generation sequencing of 22 G TBNB
vs 22 G TBNA needles
3. Sample adequacy(defined as the presence of lymphocytes or atypical cells or
other pathognomic characteristics (e.g. granulomas))
4. Sample quality using Mair*s objective scoring system
5. Sample bloodiness
6. Diagnostic sensitivity for mediastinal/hilar nodal staging (defined as the
proportion of patients that have N2/N3 disease diagnosed by EBUS-EUS-B,
relative to the total number of patients with a final diagnosis of N2/N3
disease as determined by the reference standard)
7. Diagnostic sensitivity for malignancy (defined as the proportion of patients
that have malignancy diagnosed by EBUS/EUS-B, relative to the total number of
patients with a final diagnosis of malignancy as determined by the reference
standard)
8. Yield for diagnosing malignancy in the subgroup of patients with a centrally
located lung tumor (defined as the proportion of patients that have malignancy
diagnosed by EBUS/EUS-B, relative to the total number of patients with a final
diagnosis of malignancy)
9. Complication rate
10. Procedure duration
11. Endoscopist satisfaction of needle use
Background summary
Lung cancer is the most commonly diagnosed cancer with the highest mortality
worldwide. Accurate diagnosis and staging are important because it directs
treatment and
prognosis. Staging the mediastinal and hilar lymph nodes is key in this process
and can be done with relatively high accuracy by EBUS-TBNA and EUS-(B)-FNA. The
need for high quality cytology samples for molecular analysis is growing as
endosonography is often the single test to confirm malignancy. However, current
available standard 22 G needles have limitations in obtaining tissue
core/histology samples needed for optimal molecular subtyping of lung cancer.
Recently, a dedicated fine biopsy needle (FNB) with a three-pronged cutting
edge has been developed to procure histology (22 G Franseen biopsy (Acquire**
needle, Boston Scientific)).
Study objective
To determine if EBUS / EUS-B guided nodal/lung tumor sampling with 22 Gauge (G)
TBNB (Acquire**) needles results in improved tissue core sample acquisition in
comparison to standard 22 G TBNA needles for the diagnosis and staging of lung
cancer.
Study design
Investigator-initiated, international randomized controlled multicentre
clinical trial including university and general hospitals.
Intervention
Endosonography will be performed under sedation following the institutional
practices; commonly either propofol or low dose midazolam/fentanyl sedation
will be used. All patients will undergo a systematic endosonographic evaluation
of all accessible mediastinal/hilar nodes. Following the endosonographic
inspection, nodes will be sampled from N3 to N2 to N1 to the tumor itself. The
aspirates will be processed for both tissue core analysis, cytology smears and
cell block analysis. Cytology staining and cell block preparation will be
performed following the local practice. The local pathologist will analyze
aspirates, including molecular analysis when indicated. For study purposes,
pathology samples will be digitalized, and will be reviewed by blinded
reference pathologists.
Study burden and risks
no other complication than the normal procedure with the 22 G needle
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
Patients with (suspected) NSCLC/SCLC
- Indication for mediastinal/hilar nodal or lung tumor tissue sampling
- Suspected mediastinal/hilar lymph nodes or lung tumor within reach of EBUS/
EUS-B
- 18 years or older
- Provision of a written consent
Exclusion criteria
- Mediastinal re-staging after neo-adjuvant treatment
- Contra-indication for EBUS or EUS/B
- Not correctable coagulation disorder
- Pregnancy
- Inability to consent
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 |
|---|---|
| Other | nl 7701 |
| CCMO | NL68824.018.19 |