Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

Johns Hopkins University

Status: Completed

Conditions: Lung Transplantation

Treatments: Procedure: Cryoprobe biopsy; Procedure: Forceps Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01694615

NA_00052081

Details and patient eligibility

About

Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and for surveillance in the diagnosis of acute rejection using standard transbronchial forceps. It is recognized that standard forceps biopsies underestimate the presence or degree of airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been shown in the literature to provide larger samples without crush artifact in a safe fashion in lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is superior to standard transbronchial forceps biopsies in regards to sample size, architecture and the diagnosis of early rejection in lung transplant recipients which if discovered earlier may improve survival.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals referred for either clinically indicated or surveillance flexible bronchoscopy will be included in the study population
• Age greater than 18 years and having undergone bilateral orthotopic lung transplantation

Exclusion criteria

• Coagulopathy: plts < 50,000 international normalized ratio (INR) > 1.5
• Forced expiratory volume at one second (FEV1) < 0.8
• Diffuse bullous disease
• Hemodynamic instability
• Severe hypoxemia

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cryoprobe biopsy

Active Comparator group

Description:

All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared

Treatment:

Procedure: Cryoprobe biopsy

Forceps Biopsy

Active Comparator group

Description:

All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared

Treatment:

Procedure: Forceps Biopsy