Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

NCT ID: NCT01694615

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Lung Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cryoprobe biopsy

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

Group Type ACTIVE_COMPARATOR

Cryoprobe biopsy

Intervention Type PROCEDURE

Forceps Biopsy

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

Group Type ACTIVE_COMPARATOR

Forceps Biopsy

Intervention Type PROCEDURE

Interventions

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Cryoprobe biopsy

Intervention Type PROCEDURE

Forceps Biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lonny Yarmus

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00052081

Identifier Type: -

Identifier Source: org_study_id

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