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

NCT02075762 | Completed

• 1 other identifier: NA_00083791
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Comparison of biopsy technique

  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

  Data will be measured one week post procedure

Study Arms (3)

Transbronchial biopsy

ACTIVE COMPARATOR

S-TBBx will be performed using standard biopsy forceps (Boston Scientific, Natick, MA) - 2.0mm diameter.

Procedure: Transbronchial biopsy

Cryoprobe biopsy

ACTIVE COMPARATOR

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

VATS biopsy

ACTIVE COMPARATOR

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

Interventions

Transbronchial biopsy PROCEDURE

Transbronchial biopsy

Cryoprobe biopsy PROCEDURE

Cryoprobe biopsy

VATS biopsy PROCEDURE

VATS biopsy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Duke University: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lonny Yarmus

  Johns Hopkins SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: March 3, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

US (1)