Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

Lung Transplantation Clinical Trial

Official title:

Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694615
• Other study ID #: NA_00052081
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: October 3, 2016
• Start date: November 2011
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Procedure:
• Cryoprobe biopsy

• Forceps Biopsy

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)	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.	From date of study enrollment until the patient is 2 years post lung transplant	No
Secondary	Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection)	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.	From date of study enrollment until the patient is 2 years post lung transplant	No

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