Single Scope Staging of Lung Cancer With Endosonography

NCT02014324 | Completed DMC

• 1 other identifier: NL42787.018.13
• Study Type: observational
• Target: 215
• Locations: 2 countries
• Sites: 9

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity for locoregional disease (N2, N3, T4 disease).

  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).

  from inclusion untill either pathological proof of mediastinal metastases by endospnography or 1 week after surgical verification

Secondary Outcomes (1)

• 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

Study Arms (1)

(suspected) NSCLC, mediastinal staging, endosonography

Patients with potentially medically operable and resectable NSCLC are eligible if there is an indication for pathological evaluation of mediastinal lymph nodes.

Procedure: Endosonography

Interventions

Endosonography PROCEDURE

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

Also known as: EBUS, EUS-B

(suspected) NSCLC, mediastinal staging, endosonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (9)

Onze-Lieve-Vrouwen-Ziekenhuis

Aalst, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Belgium

Location

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Location

Antoni van Leeuwenhoek ziekenhuis

Amsterdam, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, Netherlands

Location

Universitair Medisch Centrum st Radboud

Nijmegen, Netherlands

Location

Isala klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jouke T Annema, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: December 18, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 20, 2014

Record last verified: 2014-10

Locations

NL (7); BE (2)