Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

Not Applicable

Completed

• Conditions: Lung Transplantation
• Interventions: Procedure: Cryoprobe biopsy; Procedure: Forceps Biopsy

• Registration Number: NCT01694615
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryoprobe biopsy	Cryoprobe biopsy	All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared
Forceps Biopsy	Forceps Biopsy	All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared

Primary Outcome Measures

Name	Time	Method
Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)	From date of study enrollment until the patient is 2 years post lung transplant	Direct measurements of pathologic specimens from the forceps and cryoprobe will be compared. In addition, amount of crush artifact will alse be directly measured and compared utilizing pathology software which measures area of viable tissue.

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection)	From date of study enrollment until the patient is 2 years post lung transplant	Each specimen will be independently reviewed by a lung transplant pathology physician to determine the presence or absence of rejection and results compared. All data will be available to the transplant team in the event any rejection is found, it will be acted upon immediately as per the transplant teams protocol.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States