Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS (endobronchial) staging alone.
ID
Source
Brief title
Sinlge scope complete staging of lung cancer with endosonography.
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the sensitivity for loco regional disease ( N2, N3,
T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in
comparison to EBUS staging alone.
Secondary outcome
1. Sensitivity for locally advanced disease (N2-3 metastases, T4) of systematic
assessment and sampling of mediastinal lymph nodes in comparison to PET-CT
directed assessment of the mediastinum (ie targeted approach).
2. The assessment of the left adrenal gland by EUS-B is feasible.
Background summary
Lung cancer is the most commonly diagnosed cancer worldwide and is the most
frequent cause of cancer death. Accurate staging is important because it
directs treatment and prognosis. Mediastinal staging can be done by both
EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic
range and the combined procedure is suited for assessment of almost the entire
mediastinum. In practice endoscopists often perform only an EBUS or EUS when
mediastinal staging is indicated instead of the combination. It is feasible to
perform transoesophageal needle aspiration using an EBUS scope (EUS-B-FNA) and
complete endosonographic staging of the mediastinum can also be performed using
one scope. When mediastinal staging is indicated, mostly only one or two, by
imaging suspected lymph node stations, are sampled (ie. targeted approach).
This approach can underestimate the N-stage because the accuracy of PET-CT for
diagnosing mediastinal disease is not optimal.
Study objective
Complete endosonographic (combined endobronchial and esophageal) staging using
a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS
(endobronchial) staging alone.
Study design
Prospective, non-randomised diagnostic study. Setting: international,
multicenter (university and general hospitals).
Study burden and risks
The burden and risks associated with participation are considered low. Patients
that will be approached for study participation have an indication for an
endosonographic investigation. When they take part in this study the
mediastinal staging procedure will be performed more extensively by combining
an EBUS and EUS-B with routine sampling of at least three nodal stations.
meibergdreef 9
amsterdam 1105 AZ
NL
meibergdreef 9
amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
lung cancer
indication for mediastinal staging
resectable lung tumor
patient is operable
Exclusion criteria
distant metastases of lung cancer
mediastinal lymph nodes not within reach of EBUS
former lung cancer treatment
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 | NL42787.018.13 |