Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients

NCT01694615 | Completed DMC

• 1 other identifier: NA_00052081
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Keywords

Lung Transplantation; Acute Rejection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Cryoprobe biopsy

ACTIVE COMPARATOR

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

Procedure: Cryoprobe biopsy

Forceps Biopsy

ACTIVE COMPARATOR

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

Procedure: Forceps Biopsy

Interventions

Cryoprobe biopsy PROCEDURE

Cryoprobe biopsy

Forceps Biopsy PROCEDURE

Forceps Biopsy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Lonny Yarmus

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 27, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

US (1)