Transbronchial Cryobiopsy in Lung Transplant Patients

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090594
• Other study ID #: CB JKMT-2
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 20, 2017
• Start date: March 14, 2017
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Karina Loor, MD
• Phone: 93 274 6138
• Email: kloor[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2018
• Est. primary completion date: September 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Procedure:
• Biopsy
Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.

Locations

Country	Name	City	State
Spain	Hospital Vall de Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	A maximum of 6 samples will be obtained.	5-7 days.
Secondary	Number of alveoli, bronchi, bronchioles, blood vessels and pleura containing each biopsy.	The Mese Software will be used. ¨Leica Application Suite X¨.	30 days.
Secondary	Number of complications related to the procedure.	Complications related to the procedure: bleeding, pneumothorax, pneumonia, acute respiratory failure or need for hospitalization.	30 days.