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Completed

NCT Number: NCT01694615

Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

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.

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Key information

Conditions

Lung Transplantation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoprobe biopsy

Procedure

Forceps biopsy

Procedure

Primary outcomes

  1. Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)

    Time frame: 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 outcomes

  1. Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 27, 2012
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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