This trial is active, not recruiting.

Condition bronchogenic carcinoma
Treatments endobronchial or endoscopic ultrasound, bronchoscopy, ct-guided biopsy, pet scan, mediastinoscopy
Phase phase 3
Sponsor University College London Hospitals
Collaborator North Middlesex University Hospital
Start date March 2008
End date September 2011
Trial size 168 participants
Trial identifier NCT00652769, 07/0156


In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
(Active Comparator)
Control arm: Current practice for diagnosing and staging lung cancer. Most patients with intra-thoracic disease suspected of lung cancer will undergo bronchoscopy (or CT guided biopsy), PET scan and possibly mediastinoscopy.
bronchoscopy, ct-guided biopsy, pet scan, mediastinoscopy
Investigations will be determined by the multi-disciplinary team responsible for the patient
Active arm: A new pathway for the diagnosis and staging of lung cancer with endobronchial (EBUS) or endoscopic ultrasound (EUS) as a first test. If EBUS or EUS is negative the patient will have PET scan +/- mediastinoscopy.
endobronchial or endoscopic ultrasound EBUS: Olympus Keymed BF-UC260F-OL8
Patients with anterior mediastinal or subcarinal disease will undergo EBUS. Patients with posterior, subcarinal or AP window disease will undergo EUS. Patients with no mediastinal disease on CT scan will undergo EBUS.

Primary Outcomes

Time from first outpatient appointment to decision to treat
time frame: 1 - 3 months

Secondary Outcomes

The healthcare costs for diagnosing and staging lung cancer
time frame: End of study
The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer
time frame: 1 - 3 months
The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan
time frame: 1 - 3 months
The time from first outpatient appointment to treatment
time frame: 1 - 3 months
The number of futile thoracotomies
time frame: 1 - 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Consecutive patients suspected of lung cancer on CT scan - Written informed consent - Able to tolerate bronchoscopy and thoracic surgery Exclusion Criteria: - Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial - Any disorder making reliable informed consent impossible - Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion

Additional Information

Official title A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer
Principal investigator Stephen Spiro, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by University College London Hospitals.