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Completed

NCT Number: NCT02464592

Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.

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Key information

Conditions

Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years old
  • Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).
  • Inform consent signed.

Exclusion criteria

  • FEV1 <40% of reference value.
  • Respiratory insufficiency (pO2 <60 mmHg or pCO2 >45 mmHg).
  • Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio > 1.5).
  • Bullous emphysema.
  • Pulmonary arterial hypertension.
  • Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl).
  • Psychiatric illness.
  • Comorbidities that could increase the risk of the TBLB.
  • Pregnancy.

Treatment and study plan

Transbronchial lung biopsy.

Procedure

Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Primary outcomes

  1. Diagnostic yield of transbronchial lung biopsy (TBLB)

    Time frame: 24 months

    Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).

Secondary outcomes

  1. Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.

    Time frame: 24 months

    The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.

  2. Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.

    Time frame: 24 months

    Chest radiography after TBLB.

  3. Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.

    Time frame: 24 months

    Control of bleeding during procedure.

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Complejo Hospitalario Universitario de Vigo
  • Germans Trias i Pujol Hospital
  • Hospital General Universitario Santa Lucía
  • Hospital Universitari de Bellvitge
  • Hospital Universitario La Fe
  • Hospital Universitario de Valladolid
  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
  • University of Salamanca

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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