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


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Transplantation

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Trial Information

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


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 < 50K, INR > 1.5

- FEV1 < 0.8

- Diffuse bullous disease

- Hemodynamic instability

- Severe hypoxemia

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

From date of study enrollment until the patient is 2 years post lung transplant

Safety Issue:

No

Principal Investigator

Lonny Yarmus

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

NA_00052081

NCT ID:

NCT01694615

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Lung Transplantation
  • Lung Transplantation
  • Acute Rejection

Name

Location

Johns Hopkins Hospital Baltimore, Maryland  21287