Single Scope Staging of Lung Cancer With Endosonography

Completed

• Conditions: Non Small Cell Lung Cancer (NSCLC); Indication Mediastinal Staging; Complete Endosonography
• Interventions: Procedure: Endosonography

• Registration Number: NCT02014324
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
(suspected) NSCLC, mediastinal staging, endosonography	Endosonography	Patients with potentially medically operable and resectable NSCLC are eligible if there is an indication for pathological evaluation of mediastinal lymph nodes.

Primary Outcome Measures

Name	Time	Method
Sensitivity for locoregional disease (N2, N3, T4 disease).	from inclusion untill either pathological proof of mediastinal metastases by endospnography or 1 week after surgical verification	Sensitivity is defined as number of true positives (pathologic proof of a nodal metastases) divided by the number of true positives and false negatives (thoracotomy with nodal dissection is the reference standard to detect false negatives).; 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.; In the event of pathological proof of mediastinal metastases (N2/N3) by endosonography patients are classified as having locally advanced disease (stage III) and the study stops. When no mediastinal metastases are found by endosonography, surgical verification will take place (reference standard).

Secondary Outcome Measures

Name	Time	Method
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.	from inclusion untill either pathological proof of mediastinal metastases by endosonography or 1 week after surgical verification	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).

Trial Locations

Locations (9)

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Netherlands

Antoni van Leeuwenhoek ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Onze-Lieve-Vrouwen-Ziekenhuis; 🇧🇪 Aalst, Belgium

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Universitair Medisch Centrum st Radboud; 🇳🇱 Nijmegen, Netherlands

Isala klinieken; 🇳🇱 Zwolle, Netherlands