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

NCT ID: NCT02075762

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-12-31

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).

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

Conditions

Interstitial Lung Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transbronchial biopsy

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

Group Type: ACTIVE_COMPARATOR

Transbronchial biopsy

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Cryoprobe biopsy

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

VATS biopsy

Intervention Type: PROCEDURE

Interventions

Transbronchial biopsy

Intervention Type: PROCEDURE

Cryoprobe biopsy

Intervention Type: PROCEDURE

VATS biopsy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lonny Yarmus

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins SOM

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00083791

Identifier Type: -

Identifier Source: org_study_id