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

Primary Purpose

Lung Diseases, Interstitial

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transbronchial lung biopsy.
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases, Interstitial focused on measuring Cryoprobes, Transbronchial lung biopsy, Cryobiopsy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Biopsy with Cryoprobes

Biopsy with Conventional Forceps

Arm Description

Transbronchial lung biopsy with a cryoprobe.

Transbronchial lung biopsy with conventional forceps.

Outcomes

Primary Outcome Measures

Diagnostic yield of transbronchial lung biopsy (TBLB)
Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).

Secondary Outcome Measures

Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.
The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.
Chest radiography after TBLB.
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.
Control of bleeding during procedure.

Full Information

First Posted
May 6, 2015
Last Updated
September 27, 2017
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Hospital Universitario La Fe, Germans Trias i Pujol Hospital, Hospital General Universitario Santa Lucía, Hospital Universitari de Bellvitge, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Complejo Hospitalario Universitario de Vigo, University of Salamanca, Hospital Universitario de Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT02464592
Brief Title
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
Official Title
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Hospital Universitario La Fe, Germans Trias i Pujol Hospital, Hospital General Universitario Santa Lucía, Hospital Universitari de Bellvitge, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Complejo Hospitalario Universitario de Vigo, University of Salamanca, Hospital Universitario de Valladolid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial
Keywords
Cryoprobes, Transbronchial lung biopsy, Cryobiopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biopsy with Cryoprobes
Arm Type
Active Comparator
Arm Description
Transbronchial lung biopsy with a cryoprobe.
Arm Title
Biopsy with Conventional Forceps
Arm Type
Active Comparator
Arm Description
Transbronchial lung biopsy with conventional forceps.
Intervention Type
Procedure
Intervention Name(s)
Transbronchial lung biopsy.
Intervention Description
Transbronchial lung biopsy with cryoprobe and with conventional forceps.
Primary Outcome Measure Information:
Title
Diagnostic yield of transbronchial lung biopsy (TBLB)
Description
Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.
Description
The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.
Time Frame
24 months
Title
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.
Description
Chest radiography after TBLB.
Time Frame
24 months
Title
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.
Description
Control of bleeding during procedure.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Pajares, PhD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24890124
Citation
Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbon D, Amor-Carro O, Gil de Bernabe A, Franquet T, Plaza V, Hetzel J, Sanchis J, Torrego A. Diagnostic yield of transbronchial cryobiopsy in interstitial lung disease: a randomized trial. Respirology. 2014 Aug;19(6):900-6. doi: 10.1111/resp.12322. Epub 2014 Jun 1.
Results Reference
background
PubMed Identifier
32956379
Citation
Pajares V, Nunez-Delgado M, Bonet G, Perez-Pallares J, Martinez R, Cubero N, Zabala T, Cordovilla R, Flandes J, Disdier C, Torrego A; MULTICRIO Group researchers. Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study. PLoS One. 2020 Sep 21;15(9):e0239114. doi: 10.1371/journal.pone.0239114. eCollection 2020.
Results Reference
derived

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

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