Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison of Transbronchial, Cryoprobe and VATS Biopsy For the Diagnosis of Interstitial Lung Disease (ILD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01972685
First received: June 27, 2013
Last updated: August 4, 2014
Last verified: July 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) 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: Cryobiopsy biopsy
Procedure: Transbronchial Biopsy
Procedure: VATS biopsy

Study Type: Interventional
Study Design: 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 (ILD)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Comparison of biopsy technique [ Time Frame: Day of procedure, approximately 3 hours ] [ 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: 20
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cryo vs Transbronchial vs VATS biopsy
Each patient will be brought to the operating room and will undergo transbronchial, cryoprobe and VATS biopsy of the lung.
Procedure: Cryobiopsy biopsy
Cryobiopsy vs. Transbronchail vs. VATS biopsy
Procedure: Transbronchial Biopsy 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:

  • Subject provides informed consent
  • Subject is >18 years of age
  • Subject is scheduled to undergo VATS biopsy for suspected ILD as part of their standard medical care
  • A negative pregnancy test in women of child-bearing potential
  • Subject is mentally capable of understanding study procedures

Exclusion Criteria:

  • Study subject has any disease or condition that interferes with safe completion of the study including:

    • Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
    • Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease
    • 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
  • Inability to read and understand the necessary study documents
  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: NCT01972685

Contacts
Contact: Momen M Wahidi, MD, MBA 919-668-2402 momen.wahidi@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Emily Smathers, MPH    919-668-3812    emily.smathers@duke.edu   
Contact: Momen M Wahidi, MD, MBA    919-668-2402    momen.wahidi@duke.edu   
Principal Investigator: Momen M Wahidi, MD, MBA         
Sub-Investigator: Christine Argento, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Momen M Wahidi, MD, MBA Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01972685     History of Changes
Other Study ID Numbers: Pro00044455
Study First Received: June 27, 2013
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
ILD, transbronchial, cryoprobe, VATS

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

ClinicalTrials.gov processed this record on November 20, 2014