Lung TransplantationNCT01694615
Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients
A study testing Cryoprobe biopsy and Forceps Biopsy in people with Lung Transplantation, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Cryoprobe biopsy and Forceps Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation
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
- Being tested
- Cryoprobe biopsy, Forceps Biopsy
- Keywords
- Lung Transplantation, Acute Rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoprobe biopsyProcedure or surgery
Forceps BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cryoprobe biopsy | Active comparator | All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared Receives: Procedure: Cryoprobe biopsy |
| Forceps Biopsy | Active comparator | All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared Receives: Procedure: Forceps Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: From date of study enrollment until the patient is 2 years post lung transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lonny Yarmus, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694615
- Sponsor's protocol ID
- NA_00052081
- Status last verified
- Oct 2016
- First submitted
- 17 Sep 2012
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation
- ClinicalTrials.gov ID
- NCT01694615
- Acronym / sponsor ID
- NA_00052081
- Conditions
- Lung Transplantation
- Keywords
- Lung Transplantation, Acute Rejection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoprobe biopsy | Active comparator | Procedure: Cryoprobe biopsyAll patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared |
| Forceps Biopsy | Active comparator | Procedure: Forceps BiopsyAll patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoprobe biopsy | Procedure or surgery | Cryoprobe biopsy |
| Forceps Biopsy | Procedure or surgery | Forceps Biopsy |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lonny Yarmus principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoprobe biopsy and Forceps Biopsy in people with Lung Transplantation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.