Lung Transplant RejectionNCT03090581
Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation.
A study testing Biopsies CP and Biopsies FC in people with Lung Transplant Rejection, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The survival of lung transplant patients (PD) is limited mainly by Infections, graft dysfunction in the immediate postoperative period and chronic dysfunction. Up to 36% have an episode of acute rejection after transplantation. For the diagnosis of these pathologies, transbronchial lung biopsy (BPTB) is essential. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- Biopsies CP and Biopsies FC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2017to Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pulmonary transplant patients admitted to the intensive care unit who are assigned a transbronchial lung biopsy.
Who cannot join
- Respiratory insufficiency refractory to oxygen therapy.
- Acute or subacute ischemic heart disease.
- Severe arrhythmias.
- Coagulation disorders: platelets < 60,000-50,000 or Prothrombin time > 60%.
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall de Hebron.
Barcelona, Catalonia, 08035
Karina I Loor, MD, 932746138, kloor@vhebron.net
Javier De Gracia, MD PhD, 932746138, jgracia.jgracia@gmail.com
About this study
Official title: Prospective Study of Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation Admitted to an Intensive Care Unit.
The survival of lung transplant patients (PD) is limited mainly by Infections, graft dysfunction in the immediate postoperative period and chronic dysfunction. Up to 36% have an episode of acute rejection after transplantation. For the diagnosis of these pathologies, transbronchial lung biopsy (BPTB) is essential. The classical method is the realization of BPTB with conventional clamp, but the performance diagnosis is limited. However, the use of cryoprobes for sampling in other pulmonary pathologies have been shown to achieve a higher diagnostic yield. The BPTB performance is variable and depends on factors such as sample size and the presence of artifacts (crushing) produced by the forceps tweezers. The objective principal is to compare the diagnostic yield of samples obtained with cryoprobe compared to those obtained with conventional biopsy tweezers. A prospective, randomized, and comparative study is proposed for all patients in the intensive care unit after lung transplantation in a 24-month period, at Vall de Hebron Hospital. Patients will be divided into two groups: symptomatic and asymptomatic. The exclusion criteria are the contraindications of the procedure and the factors which increase the hemorrhagic risk. A flexible bronchoscope (BF-18BS) will be used and the procedure will be performed according to the technique conventional. The patient undergoing the procedure will be intubated, sedated and relaxed under supervision and continuous monitoring by an intensivist. A bronchoalveolar lavage and a maximum of 6 samples will be obtained. Morphological study (middle area, artifacts, components, diagnosis), microbiological, histological and anatomopathological according to the usual protocol. The duration of the procedure, the complications and the frequency with which the diagnosis obtained after the procedure modifies the therapeutic behavior will be monitored. These data will allow to evaluate the potential benefits of this procedure in the diagnosis of pulmonary pathology in lung transplantation.
Read the detailed description
Bronchoscopic examinations will be performed with intubated patients under continuous monitoring (pulse oximetry, blood pressure, heart and respiratory rate), Oxygen therapy with high flows and surveillance by anesthesiologist. The bronchopulmonary lobe where the biopsies will be performed is determined prior to the procedure based on an imaging study (chest x-ray or computed tomography). Transbronchial biopsies will be obtained using a flexible bronchoscope (Pentax, 3.2 mm working channel), which approaches the subsegment where the affected area is located. The 2.4 mm diameter cryoprobe is placed (Erbokryo®), and moves forward until it encounters a soft resistance. The cryoprobe is removed between 5-10 mm and the freezing is applied for 3 seconds. After 3 seconds, the probe is gently removed together with the bronchoscope and frozen tissue sample at the tip of the probe. In the case of strong resistance, the process is stopped and then repeated. In the case of the use of forceps, the conventional technique is used.
- Conditions
- Lung Transplant Rejection
- Being tested
- Biopsies CP, Biopsies FC
- Keywords
- Graft Rejection/diagnosis, Lung Transplantation, Cryoprobe
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies CPProcedure or surgery
Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.
Biopsies FCProcedure or surgery
Transbronchial biopsies will be obtained with a flexible bronchoscope, using a forceps.
| Study group | Role | What they receive |
|---|---|---|
| Biopsies CP 1 | Active comparator | Obtain transbronchial lung biopsies with cryoprobe (CP) 1 Receives: Procedure: Biopsies CP |
| Biopsies CP 2 | Active comparator | Obtain transbronchial lung biopsies with cryoprobe (CP) 2 Receives: Procedure: Biopsies CP |
| Biopsies FC | Active comparator | Obtain transbronchial lung biopsies with forceps (FC). Receives: Procedure: Biopsies FC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in whom a pathological diagnosis is obtained after obtaining transbronchial biopsies, performed with forceps or cryosondes.
Graft rejection is classified according to the criteria of the International Society for Heart and Lung Transplantation (ISHLT) in 2007.
Measured: 5 days after biopsies
Secondary outcomes (2)
Number of alveoli, bronchioles, bronchi, blood vessels and pleura containing each biopsy.
A microscope will be used with Software Mese. ¨Leica Application Suite X¨.
Measured: 5 days after biopsies
Number of complications related to the procedure.
Complications: bleeding, pneumothorax, infection or acute respiratory failure.
Measured: 30 days after biopsies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start15 Mar 2017
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier De Gracia, Pneumologist, Principal investigator, Respiratory departmentKarina I Loor, MD, Study chair, Respiratory departmentMario Culebras, MD, Study chair, Respiratory departmentAntonio Álvarez, MD, Study chair, Respiratory department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090581
- Sponsor's protocol ID
- CB JKMT-1
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no.
Publications
Loor K, Culebras M, Sansano I, Alvarez A, Sacanell J, Garcia-de-Acilu M, Berastegui C, Polverino E, Clofent D, de Gracia J. Lung allograft transbronchial cryobiopsy for critical ventilated patients: a randomised trial. Eur Respir J. 2023 Jan 6;61(1):2102354. doi: 10.1183/13993003.02354-2021. Print 2023 Jan.
PubMed 35896217
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation Admitted to an Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03090581
- Acronym / sponsor ID
- CB JKMT-1
- Conditions
- Lung Transplant Rejection
- Keywords
- Graft Rejection/diagnosis, Lung Transplantation, Cryoprobe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 27 Mar 2017 (actual)
- 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.
The survival of lung transplant patients (PD) is limited mainly by Infections, graft dysfunction in the immediate postoperative period and chronic dysfunction. Up to 36% have an episode of acute rejection after transplantation. For the diagnosis of these pathologies, transbronchial lung biopsy (BPTB) is essential. The classical method is the realization of BPTB with conventional clamp, but the performance diagnosis is limited. However, the use of cryoprobes for sampling in other pulmonary pathologies have been shown to achieve a higher diagnostic yield. The BPTB performance is variable and depends on factors such as sample size and the presence of artifacts (crushing) produced by the forceps tweezers. The objective principal is to compare the diagnostic yield of samples obtained with cryoprobe compared to those obtained with conventional biopsy tweezers. A prospective, randomized, and comparative study is proposed for all patients in the intensive care unit after lung transplantation in a 24-month period, at Vall de Hebron Hospital. Patients will be divided into two groups: symptomatic and asymptomatic. The exclusion criteria are the contraindications of the procedure and the factors which increase the hemorrhagic risk. A flexible bronchoscope (BF-18BS) will be used and the procedure will be performed according to the technique conventional. The patient undergoing the procedure will be intubated, sedated and relaxed under supervision and continuous monitoring by an intensivist. A bronchoalveolar lavage and a maximum of 6 samples will be obtained. Morphological study (middle area, artifacts, components, diagnosis), microbiological, histological and anatomopathological according to the usual protocol. The duration of the procedure, the complications and the frequency with which the diagnosis obtained after the procedure modifies the therapeutic behavior will be monitored. These data will allow to evaluate the potential benefits of this procedure in the diagnosis of pulmonary pathology in lung transplantation.
Detailed description
Bronchoscopic examinations will be performed with intubated patients under continuous monitoring (pulse oximetry, blood pressure, heart and respiratory rate), Oxygen therapy with high flows and surveillance by anesthesiologist. The bronchopulmonary lobe where the biopsies will be performed is determined prior to the procedure based on an imaging study (chest x-ray or computed tomography). Transbronchial biopsies will be obtained using a flexible bronchoscope (Pentax, 3.2 mm working channel), which approaches the subsegment where the affected area is located. The 2.4 mm diameter cryoprobe is placed (Erbokryo®), and moves forward until it encounters a soft resistance. The cryoprobe is removed between 5-10 mm and the freezing is applied for 3 seconds. After 3 seconds, the probe is gently removed together with the bronchoscope and frozen tissue sample at the tip of the probe. In the case of strong resistance, the process is stopped and then repeated. In the case of the use of forceps, the conventional technique is used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biopsies CP 1 | Active comparator | Procedure: Biopsies CPObtain transbronchial lung biopsies with cryoprobe (CP) 1 |
| Biopsies CP 2 | Active comparator | Procedure: Biopsies CPObtain transbronchial lung biopsies with cryoprobe (CP) 2 |
| Biopsies FC | Active comparator | Procedure: Biopsies FCObtain transbronchial lung biopsies with forceps (FC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pulmonary transplant patients admitted to the intensive care unit who are assigned a transbronchial lung biopsy.
Key exclusion criteria (5 listed)
- Respiratory insufficiency refractory to oxygen therapy.
- Acute or subacute ischemic heart disease.
- Severe arrhythmias.
- Coagulation disorders: platelets < 60,000-50,000 or Prothrombin time > 60%.
- Lack of informed consent.
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 |
|---|---|---|
| Biopsies CPTransbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe. | Procedure or surgery | Biopsies CP 1, Biopsies CP 2 |
| Biopsies FCTransbronchial biopsies will be obtained with a flexible bronchoscope, using a forceps. | Procedure or surgery | Biopsies FC |
Primary outcome
Number of patients in whom a pathological diagnosis is obtained after obtaining transbronchial biopsies, performed with forceps or cryosondes.
Time frame: 5 days after biopsies
Graft rejection is classified according to the criteria of the International Society for Heart and Lung Transplantation (ISHLT) in 2007.
2 secondary outcomes
Number of alveoli, bronchioles, bronchi, blood vessels and pleura containing each biopsy.
Time frame: 5 days after biopsies
Number of complications related to the procedure.
Time frame: 30 days after biopsies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 35896217Loor K, Culebras M, Sansano I, Alvarez A, Sacanell J, Garcia-de-Acilu M, Berastegui C, Polverino E, Clofent D, de Gracia J. Lung allograft transbronchial cryobiopsy for critical ventilated patients: a randomised trial. Eur Respir J. 2023 Jan 6;61(1):2102354. doi: 10.1183/13993003.02354-2021. Print 2023 Jan.
- Individual participant dataSharing planned: No. no.
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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.
Javier De Gracia, Pneumologist principal investigator
Respiratory department
Karina I Loor, MD study chair
Respiratory department
Mario Culebras, MD study chair
Respiratory department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies CP and Biopsies FC in people with Lung Transplant Rejection, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Mar 2017. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina I Loor, MD (93 274 6138 ext. 6496, kloor@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in whom a pathological diagnosis is obtained after obtaining transbronchial biopsies, performed with forceps or cryosondes. (time frame: 5 days after biopsies). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03090581, which also lists 1 linked publication.
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 29 Mar 2017.