Transbronchial Cryobiopsy in Lung Transplant Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplantation
• Intervention / Treatment: Procedure: Biopsy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Vall de Hebron
    • Contact: Karina Loor, MD; Phone Number: 93 274 6138; Email: kloor@vhebron.net
    • Contact: Javier De Gracia, MD; Phone Number: 93 274 6138; Email: jgracia.jgracia@gmail.com
    • Sub-Investigator: Karina Loor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Biopsy; Transbronchial biopsies with cryoprobe.	Procedure: Biopsy; Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Javier De Gracia, MD PhD, Respiratory department.; Study Chair: Karina Loor, MD, Respiratory department.; Study Chair: Mario Culebras, MD, Respiratory department.; Study Chair: Antonio Álvarez, MD, Respiratory department.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2017
• Primary Completion (ANTICIPATED): September 17, 2017
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (ACTUAL): March 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Bronchoscopy; Acute cellular rejection; Cryoprobe
• Other Study ID Numbers: CB JKMT-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No