Comparison of Transbronchial, Cryoprobe, and VATS Biopsy for the Diagnosis of Interstitial Lung Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Johns Hopkins University
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Lonny Yarmus, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02075762
First received: September 3, 2013
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

The objective of this study is to compare the sample size, architectural preservation and diagnostic yield of bronchoscopic cryo-probe transbronchial lung biopsy (C-TBBx) in comparison to bronchoscopic standard transbronchial lung biopsy (S-TBBx) and Video-Assisted Thoracoscopic Surgery (VATS) lung biopsy for the diagnosis of interstitial lung disease (ILD).


Condition Intervention
Interstitial Lung Disease
Procedure: Transbronchial biopsy
Procedure: Cryoprobe biopsy
Procedure: VATS biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Transbronchial, Cryoprobe, and VATS Biopsy for the Diagnosis of Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Comparison of biopsy technique [ Time Frame: Data will be measured one week post procedure ] [ Designated as safety issue: No ]
    The number and size of all biopsies, architectural preservation of the airways/alveoli, and pathological diagnosis will be reported by the pathologist. Diagnostic yield will be calculated for each biopsy technique and compared


Estimated Enrollment: 16
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transbronchial biopsy
S-TBBx will be performed using standard biopsy forceps (Boston Scientific, Natick, MA) - 2.0mm diameter.
Procedure: Transbronchial biopsy
Active Comparator: Cryoprobe biopsy
C-TBBx will be performed using the cryoprobe (ERBE, Tubingen, Germany) -1.9 mm diameter, 78cm in length. This cryoprobe is routinely used in the bronchoscopy suite for carcinoma-TBBX; therefore it is a technique already employed by the interventional pulmonologists who are familiar with its use.
Procedure: Cryoprobe biopsy
Active Comparator: VATS biopsy
Once the biopsies are obtained by the interventional pulmonologist, the thoracic surgeon will perform VATS biopsy. Following their procedure, subjects will be monitored in the post-anesthesia care unit as per standard of care. As part of their ongoing follow-up care, all subjects will be monitored for any adverse events that may have resulted from either the surgical or bronchoscopic procedure, specifically bleeding or pneumothorax.
Procedure: VATS biopsy

Detailed Description:

This is a prospective cohort study in which 20 subjects that have suspected ILD who are undergoing non-emergent surgical biopsy will be enrolled.

Patients who have been referred to the thoracic surgery service for VATS biopsy to diagnose suspected ILD and meet basic inclusion/exclusion criteria will be approached by the study investigators and informed of the study. An informed consent will be obtained during the clinic visit with the thoracic surgeon.

At the beginning of the surgical procedure, under general anesthesia in the operating room, patients will undergo flexible bronchoscopy through the endotracheal tube and obtain 10 standard transbronchial biopsies (S-TBBx) and 5 Cryoprobe biopsies (C-TBBx) with fluoroscopic guidance. S-TBBx will be performed using standard biopsy forceps (Boston Scientific, Natick, MA) - 2.0mm diameter. C-TBBx will be performed using the cryoprobe (ERBE, Tubingen, Germany) -1.9 mm diameter, 78cm in length. This cryoprobe is routinely used in the bronchoscopy suite for other applications such as foreign body removal and local treatment of carcinoma; therefore it is a technique already employed by the interventional pulmonologists who are familiar with its use. Once the biopsies are obtained by the interventional pulmonologist, the thoracic surgeon will perform video-assisted thoracoscopic biopsy (VATS) biopsy. Following their procedure, subjects will be monitored in the post-anesthesia care unit as per standard of care. As part of their ongoing follow-up care, all subjects will be monitored for any adverse events that may have resulted from either the surgical or bronchoscopic procedure, specifically bleeding or pneumothorax.

All biopsy samples will be analyzed by a specialist in pulmonary pathology.

The number and size of all biopsies, architectural preservation of the airways/alveoli, and pathological diagnosis will be reported by the pathologist. Diagnostic yield will be calculated for each biopsy technique and compared

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years of age
  • Scheduled VATS biopsy for suspected ILD as part of standard medical care
  • Negative pregnancy test
  • Mentally capable of understanding study procedures

Exclusion Criteria:

  • A disease or condition that interferes with safe completion of the study including:

    • Platelet count < 50,000 Coagulopathy defined as an International
    • Normalized Ratio (INR) > 1.5, or discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
    • Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
    • Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements
  • Concurrent participation in another study involving investigational drugs or investigational medical devices
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02075762

Contacts
Contact: Karen Oakjones-Burgess 4109555288 kfriel2@jhmi.edu
Contact: Ricardo Ortiz rortiz7@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Karen Oakjones-Burgess    410-955-5288    kfriel2@jhmi.edu   
Principal Investigator: Lonny Yarmus         
Sponsors and Collaborators
Johns Hopkins University
Duke University
Investigators
Principal Investigator: Lonny Yarmus Johns Hopkins SOM
  More Information

No publications provided

Responsible Party: Lonny Yarmus, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02075762     History of Changes
Other Study ID Numbers: NA_00083791
Study First Received: September 3, 2013
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014