NCT02014324

Single Scope Staging of Lung Cancer With Endosonography

Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 215 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer (NSCLC)
• Indication Mediastinal Staging
• Complete Endosonography

Interventions

Type	Name	Description
PROCEDURE	Endosonography	Complete endosonographic mediastinal staging is performed in 2 steps: 1. Systematic EBUS (airways) 2. Systematic EUS-B (esophagus)

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-12-18
• Last updated: 2014-10-20

Locations

9 sites across 2 countries: Belgium, Netherlands