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Transbronchial Cryobiopsy in Lung Transplant Patients

Diagnostic Performance and Complications of Transbronchial Cryobiopsy in Lung Transplant Patients According to the Number of Samples Obtained

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03090594
Enrollment
50
Registered
2017-03-27
Start date
2017-03-14
Completion date
2018-03-31
Last updated
2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplantation

Keywords

Cryoprobe, Bronchoscopy, Acute cellular rejection

Brief summary

Cryobiopsy has displaced the transbronchial biopsy (BTB) with forceps because it allows to obtain samples of more representative pulmonary parenchyma with more alveoli, less artifacts and a greater diagnostic yield. However, some authors report an increase in adverse effects such as hemorrhage and pneumothorax. The latest ISHLT (International Society for Heart and Lung Transplantation) consensus of 2007 recommends that with BTB with forceps a minimum of five tissue samples should be obtained that should contain more than 100 wells or the presence of two bronchioles to Which may be necessary between 3 and 17 samples. The optimal number of transbronchial cryobiopsies is unknown in order to obtain maximum performance with the lowest possible morbidity. It is proposed to analyze the morphological and histopathological characteristics of each cryobiopsies individually and in order of extraction, to determine the sensitivity in the diagnosis of acute rejection as a function of the number of samples. Lung transplant patients, not admitted to critical units, with BTB indication will be included. A maximum of 6 samples will be obtained by flexible bronchoscope and under general anesthesia. These data will allow to know the minimum number of specimens that guarantee a histological and / or bacteriological diagnosis of certainty with maximum effectiveness.

Detailed description

Transbronchial biopsies (BPTB) will be performed using a flexible bronchoscope and the biopsy will be performed with cryoprobe (Erbokryo®). The patient undergoing the procedure will be intubated, sedated and relaxed under continuous monitoring (pulse oximetry, blood pressure, heart and respiratory rate), oxygen therapy with high flows and surveillance by anesthesiologist. The site where the biopsies will be performed will be determined based on an imaging study (chest x-ray and / or CT scan). The procedure will be performed according to the conventional technique, keeping the patient in apnea during the time that the cryobiopsies are taken to reduce the risk of pneumothorax. At most 6 samples will be obtained, and each one will be placed in an individual container listed in order of extraction. Bronchoalveolar lavage (3 aliquots of 30 mL sterile saline solution) will be performed in the same hemithorax. The samples obtained will be evaluated morphologically and sent to a microbiological and histopathological study, which will include a cell count. The data obtained will be coded.

Interventions

PROCEDUREBiopsy

Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pulmonary transplant patients with suspected rejection or infection requiring transbronchial biopsy

Exclusion criteria

* Respiratory failure refractory to oxygen therapy. * Acute or subacute ischemic heart disease (last 4-6 weeks). * Severe arrhythmias. * Coagulation disorders: platelets \<60,000-50,000 or Prothrombin time \<60%. * Lack of consent informed.

Design outcomes

Primary

MeasureTime frameDescription
Number of transbronchial biopsies with which a pathological diagnosis is obtained. The rejection graduation according to the criteria of the International Society for Heart Lung Transplantation (ISHLT).5-7 days.A maximum of 6 samples will be obtained.

Secondary

MeasureTime frameDescription
Number of alveoli, bronchi, bronchioles, blood vessels and pleura containing each biopsy.30 days.The Mese Software will be used. ¨Leica Application Suite X¨.
Number of complications related to the procedure.30 days.Complications related to the procedure: bleeding, pneumothorax, pneumonia, acute respiratory failure or need for hospitalization.

Countries

Spain

Contacts

Primary ContactKarina Loor, MD
kloor@vhebron.net93 274 6138
Backup ContactJavier De Gracia, MD PhD
jgracia.jgracia@gmail.com93 274 6138

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026