Clinical trial NCT02014324: Single Scope Staging of Lung Cancer With Endosonography
Official title: Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer (NSCLC)
Indication Mediastinal Staging
Complete Endosonography
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2013-12-18
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.

Brief summary: Rationale: 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, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach).

Objectives: main and secondary:

1. Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.
2. Systematic mediastinal staging results in improved locoregional staging compared to PET-CT directed assessment of the mediastinum (ie targeted approach).

Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.

Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled.

Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.


Eligibility criteria: Inclusion Criteria:

* (Suspected) NSCLC;
* Indication for mediastinal nodal assessment;
* Suspected mediastinal lymph nodes within reach of EBUS;
* Age 18 years or older;
* Clinically fit to undergo surgical resection of the lung tumor;
* Provision of a written informed consent;

Exclusion Criteria:

* Mediastinal re-staging after neo-adjuvant treatment;
* Indication for EUS other than mediastinal staging, eg a for malignancy
* suspected left adrenal;
* Active malignancy with a life expectancy of less than two years;
* Former therapy for lung cancer (chemotherapy, radiotherapy or surgery);
* Technical contraindication for EBUS or EUS (eg, esophagus stenosis);
* Pregnancy;
* Inability to consent;

Primary outcomes:
measure: Sensitivity for locoregional disease (N2, N3, T4 disease).
timeFrame: from inclusion untill either pathological proof of mediastinal metastases by endospnography or 1 week after surgical verification
Secondary outcomes:
measure: Sensitivity for locally advanced disease (N2-3 metastases, T4). Systematic assessment and sampling of mediastinal lymph nodes versus PET-CT directed assessment of the mediastinum.
timeFrame: from inclusion untill either pathological proof of mediastinal metastases by endosonography or 1 week after surgical verification
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwen-Ziekenhuis
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek ziekenhuis
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum st Radboud
city: Zwolle
country: Netherlands
facility: Isala klinieken
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jouke T Annema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: