NCT02464592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

May 6, 2015

Last Update Submit

September 27, 2017

Conditions

Lung Diseases, Interstitial

Keywords

CryoprobesTransbronchial lung biopsyCryobiopsy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield of transbronchial lung biopsy (TBLB)

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

    24 months

Secondary Outcomes (3)

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

    24 months

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

    24 months

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

    24 months

Study Arms (2)

Biopsy with Cryoprobes

ACTIVE COMPARATOR

Transbronchial lung biopsy with a cryoprobe.

Procedure: Transbronchial lung biopsy.

Biopsy with Conventional Forceps

ACTIVE COMPARATOR

Transbronchial lung biopsy with conventional forceps.

Procedure: Transbronchial lung biopsy.

Interventions

Transbronchial lung biopsy.PROCEDURE

Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Biopsy with Conventional ForcepsBiopsy with Cryoprobes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (2)

  • 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.

    PMID: 24890124BACKGROUND

  • 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.

    PMID: 32956379DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Virginia Pajares, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

June 8, 2015

Study Start

April 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

ES(1)