Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation.

NCT03090581 | Unknown

• 1 other identifier: CB JKMT-1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Transplant Rejection

Keywords

Graft Rejection/diagnosis; Lung Transplantation; Cryoprobe

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of alveoli, bronchioles, bronchi, blood vessels and pleura containing each biopsy.

  5 days after biopsies

• Number of complications related to the procedure.

  30 days after biopsies

Study Arms (3)

Biopsies CP 1

ACTIVE COMPARATOR

Obtain transbronchial lung biopsies with cryoprobe (CP) 1

Procedure: Biopsies CP

Biopsies CP 2

ACTIVE COMPARATOR

Obtain transbronchial lung biopsies with cryoprobe (CP) 2

Procedure: Biopsies CP

Biopsies FC

ACTIVE COMPARATOR

Obtain transbronchial lung biopsies with forceps (FC).

Procedure: Biopsies FC

Interventions

Biopsies CP PROCEDURE

Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.

Biopsies CP 1; Biopsies CP 2

Biopsies FC PROCEDURE

Transbronchial biopsies will be obtained with a flexible bronchoscope, using a forceps.

Biopsies FC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pulmonary transplant patients admitted to the intensive care unit who are assigned a transbronchial lung biopsy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Vall de Hebron.

Barcelona, Catalonia, 08035, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 35896217 DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier De Gracia, Pneumologist

  Respiratory department

  PRINCIPAL INVESTIGATOR

• Karina I Loor, MD

  Respiratory department

  STUDY CHAIR

• Mario Culebras, MD

  Respiratory department

  STUDY CHAIR

• Antonio Álvarez, MD

  Respiratory department

  STUDY CHAIR

Central Study Contacts

Karina I Loor, MD

CONTACT

93 274 6138; kloor@vhebron.net

Javier De Gracia, MD PhD

CONTACT

93 274 6138; jgracia.jgracia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A prospective, randomized, comparative study in all patients.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 27, 2017
• Study Start: March 15, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)