Clinical trial NCT02464592: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases, Interstitial
Keywords: Cryoprobes
Transbronchial lung biopsy
Cryobiopsy
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
name: Germans Trias i Pujol Hospital
name: Hospital General Universitario Santa Lucía
name: Hospital Universitari de Bellvitge
name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Complejo Hospitalario Universitario de Vigo
name: University of Salamanca
name: Hospital Universitario de Valladolid
First posted: 2015-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Diagnostic yield of transbronchial lung biopsy (TBLB)
timeFrame: 24 months
Secondary outcomes:
measure: Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.
timeFrame: 24 months
measure: Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.
timeFrame: 24 months
measure: Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Virginia Pajares, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.