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Comparing Diagnostic Yield Between R-EBUS Guided Cryo Biopsy Vs. CT Guided Biopsy for PPL (CT-CROP)

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ClinicalTrials.gov Identifier: NCT02395939
Recruitment Status : Unknown
Verified October 2015 by Samantha Herath, Middlemore Hospital, New Zealand.
Recruitment status was:  Recruiting
First Posted : March 24, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Samantha Herath, Middlemore Hospital, New Zealand

Brief Summary:

Obtaining a tissue sample to diagnose a PPL suspected of cancerous origin is of utmost importance. The current gold standard; Transthoracic CT guided needle biopsy approach with a success rate of >90% comes at the expense of an increased side effect profile.

Given that most lung cancers originate in the bronchus, hence named "bronchogenic carcinoma", it would be rational to think that endobronchial route should provide the best route of sampling with the least amount of side effects. Radial EBUS has become popular during the last decade as an endobronchial modality in diagnosing PPL with minimal side effects. However, the yield is still not satisfactory in comparison to CT guided biopsy with only 73% success rate in a meta-analysis. There is also with wide variation in different centres.

Use of a new biopsy method called cryo-biopsy using the R-EBUS guide sheath may bridge the gap and increase the diagnostic yield of PPL.

Cryo biopsy had been proven to give larger sample sizes and reduced crush artefact compared to the conventional radial EBUS biopsies.

However, there have been no head to head trials comparing Cryo-probe biopsy vs. the gold standard: CT guided biopsy.

Cryo-biopsy has very favourable side effect profile without any pneumothorax occurrence. If the yield were to be non-inferior to CT guided biopsy this would certainly be the preferred choice of biopsy for PPL in the future.

Methodology All patients with a PPL requiring a diagnostic biopsy will be eligible for recruitment to the trial. The recruited patients will be randomly allocated to either CT guided core biopsy or radial EBUS guided cryobiopsy.

Study design Multi centre intervetional,randomised control trial.

Study population:

Patients diagnosed with a PPL that requires a biopsy.

If the patient is randomised to the cryo biopsy arm:

The procedure will be done under the usual guidelines and practice of the centre as for a flexible bronchoscopy procedure.

Once flexible bronchoscopy is introduced the pre-determined desired segment, the R-EBUS is inserted covered by the GS.

Once the R EBUS locates the lesion, the GS is left in situ and the USS probe is retracted.

The cryoprobe is then inserted through the GS to the desired location. Flexible Cryoprobe (outer diameter 1.9mm) will be applied for 4 seconds for each biopsy. The cryogen gas used will be Co2.

The probe will be retracted together with the GS and the bronchoscope en masse after each biopsy. A minimum of 1 and maximum of 3 samples will be taken.

A CXR is taken within 1 hour post procedure to access for pneumothorax. Adverse events during the procedure will be recorded. If a chest tube placement, other investigations due to side effects or overnight hospital stay were to be required; all costs will be calculated retrospectively. Minor bleeding will not be considered an additional cost as this occurs with routine bronchoscopy.

If the patient is randomised to the CT biopsy arm:

A CT guided core biopsy will be performed as per usual practice of that centre. 2-6 passes will be performed for each PPL.

A CXR 1hour post procedure will be performed to assess for pneumothorax or procedure related bleeding.

If a chest tube placement, other investigations due to side effects or overnight hospital stay were to be required all costs will be calculated retrospectively.

At the pathology:

All samples will be assessed for the size of the sample and the suitability for molecular testing. An independent pathologist will assess samples.

Economic analysis:

For both procedures: Both direct and indirect costs will be calculated. The main aim of cost analysis is to calculate the cost of side effect management in each arm to determine the most cost-effective method of sampling a PPL.


Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: CT guided core biopsy Procedure: Cryo-biopsy via Radial EBUS navigation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomised Controlled Trial Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound (R-EBUS) Guided Cryo-biopsy Vs. CT-guided Transthoracic Biopsy in Patients With Parenchymal Lung Lesion, Suspected of Lung Cancer (CT-CROP)
Study Start Date : July 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: CT guided core biopsy
In patients allocated to this arm a CT guided core biopsy will be performed
Procedure: CT guided core biopsy
CT guided biopsy will be performed by a trained interventional radiologist using core biopsy.

Active Comparator: Cryo-biopsy via Radial EBUS navigation

If the patient is randomised to this arm, the lesion will be located via R-EBUS.

Each patient will have 3 cryo biopsies and 3 forceps biopsies. The order of the cryo biopsy and forcep biopsy will be randomly allocated at the time of initial randomisation.

Procedure: Cryo-biopsy via Radial EBUS navigation
Cryo-biopsy will be performed via R-EBUS guidance. Cryo biopsy probe will be applied for 4 seconds for each biopsy and a minimum of 3 biopsies will be performed . Each patient will also have 3 forceps biopsies. The order of forceps biopsy or cryo biopsy will be randomly allocated.




Primary Outcome Measures :
  1. Diagnostic yield of cryo biopsy Vs. CT guided biopsy as measured by final histological diagnosis [ Time Frame: 2 years ]
    This outcome measures the efficacy of CT guided biopsy (The current Gold standard) against the new biopsy method called cryo-biopsy which has better safety profile from previous pilot studies.


Secondary Outcome Measures :
  1. Safety profile as measured by the rate of pneumothorax and bleeding [ Time Frame: 2 years ]
    The CT guided biopsy has good efficacy rates but a high risk of pneumothorax (up to 30%) and pulmonary haemorrhage (4-27%), which requires further management adding to the cost of the intervention. The cryobiopsy method had been proven in pilot studies to have a better safety profile with <1% pneumothorax risk. Hence comparing the side effect profile and if cryo biopsy is far safer alternative would make this the first option for the patient.

  2. Ability to sub type and molecular type the biopsy sample over and above the conventional radial EBUS samples [ Time Frame: 2 years ]
    Cryo biopsy gives a larger sample size and hypothesized to give a better molecular analysis for EGFR mutation and ALK mutation analysis


Other Outcome Measures:
  1. Cost analysis between cryo biopsy and CT guided biopsy for PPL [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients aged >18 years with a peripheral pulmonary lesion, suspected of lung cancer, requiring a biopsy
  • The lesion will be included irrespective of the relationship to the bronchus or ground glass appearance.

Exclusion Criteria:

  1. Patients with mediastinal adenopathy amenable to liner EBUS should have this procedure first and enrolled only if it fails to derive a diagnosis.
  2. Endobronchial tumour on flexible bronchoscopy
  3. Platelet count>150
  4. International Normalised Ratio >=1.5
  5. Haemoglobin>100
  6. Neutrophils >1.0
  7. Glomerular Filtration Rate>30
  8. Liver Function Test< 2 times upper limit of normal
  9. Unable to give consent/intellectually impaired

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395939


Contacts
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Contact: Samantha Herath, MBBS, MPhil, FRACP 0064-211298979 samantha.herath@middlmeore.co.nz

Locations
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New Zealand
Middlemore Hospital, Recruiting
Auckland,, New Zealand, 2025
Contact: Samantha Herath, MBBS, MPhil, FRACP    0064-211298979    samantha.herath@middlemore.co.nz   
Contact: Andrew Veale, FRACP    0061-9-2760000    Andrew.Veale@middlemore.co.nz   
Sponsors and Collaborators
Middlemore Hospital, New Zealand
Investigators
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Principal Investigator: Samantha Herath, MBBS, FRACP Middlemore Hospital, New Zealand
Publications of Results:
S H. CT guided lung biospy-FNA or core biospy? Royal Australian New Zealand College of Radiology 2013;2013 Abstract

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Responsible Party: Samantha Herath, Respiratory Physician, Intervetional bronchoscopist, Middlemore Hospital, New Zealand
ClinicalTrials.gov Identifier: NCT02395939    
Other Study ID Numbers: CT-CROP
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by Samantha Herath, Middlemore Hospital, New Zealand:
Cryobiopsy
Radial EBUS
Guide Sheath
Peripheral pulmonary lesions
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases