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

Lung Diseases, Interstitial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464592
• Other study ID #: IIBSP-CRI-2014-05
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: September 27, 2017
• Start date: April 2014
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• Transbronchial lung biopsy.
Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (9)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Complejo Asistencial Universitario de Salamanca, Complexo Hospitalario Universitario de Vigo, Germans Trias i Pujol Hospital, Hospital General Universitario Santa Lucía, Hospital Universitari de Bellvitge, Hospital Universitario de Valladolid, Hospital Universitario La Fe, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbón D, Amor-Carro O, Gil de Bernabé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 months
Secondary	Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.	Chest radiography after TBLB.	24 months
Secondary	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.	24 months