Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation.

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplant Rejection
• Intervention / Treatment: Procedure: Biopsies CP; Procedure: Biopsies FC

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 Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Recruiting
      • Hospital Vall de Hebron.
      • Contact: Karina I Loor, MD; Phone Number: 932746138; Email: kloor@vhebron.net
      • Contact: Javier De Gracia, MD PhD; Phone Number: 932746138; Email: jgracia.jgracia@gmail.com
      • Sub-Investigator: Karina I 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 admitted to the intensive care unit who are assigned a transbronchial lung biopsy.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biopsies CP 1; Obtain transbronchial lung biopsies with cryoprobe (CP) 1	Procedure: Biopsies CP; Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.
Active Comparator: Biopsies CP 2; Obtain transbronchial lung biopsies with cryoprobe (CP) 2	Procedure: Biopsies CP; Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.
Active Comparator: Biopsies FC; Obtain transbronchial lung biopsies with forceps (FC).	Procedure: Biopsies FC; Transbronchial biopsies will be obtained with a flexible bronchoscope, using a forceps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 days after biopsies

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of alveoli, bronchioles, bronchi, blood vessels and pleura containing each biopsy.	A microscope will be used with Software Mese. ¨Leica Application Suite X¨.	5 days after biopsies
Number of complications related to the procedure.	Complications: bleeding, pneumothorax, infection or acute respiratory failure.	30 days after biopsies

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Javier De Gracia, Pneumologist, Respiratory Department; Study Chair: Karina I 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 15, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Lung Transplantation; Graft Rejection/diagnosis; Cryoprobe
• Other Study ID Numbers: CB JKMT-1

Plan for Individual participant data (IPD)

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