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Interstitial Lung Disease (ILD). Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy in the Same Surgical Stage.

Primary Purpose

Lung Diseases, Interstitial

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Lung biopsy

About this trial

This is an interventional diagnostic trial for Lung Diseases, Interstitial focused on measuring Interstitial lung disease, cryobiopsy, surgical biopsy

Eligibility Criteria

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

Inclusion Criteria:

Patients for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach.
Subject provides informed consent.
A negative pregnancy test in women of child-bearing potential.
Subject is mentally capable of understanding study procedures.
18 years and older.

Exclusion Criteria:

Study subject has any disease or condition that interferes with safe completion of the study including:
Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease
Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements
Concurrent participation in another study involving investigational drugs or investigational medical devices
Inability to read and understand the necessary study documents

Sites / Locations

Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lung biopsy

Arm Description

Lung biopsy

Outcomes

Primary Outcome Measures

Quality of the tissue sample reported by the pathologist.

comparison of diagnostic yield of cryobiopsy versus surgical lung biopsy according to the quality of the tissue sample reported by the pathologist.

Secondary Outcome Measures

Full Information

NCT ID

NCT03596528

First Posted

July 12, 2018

Last Updated

July 24, 2018

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT03596528

Brief Title

Interstitial Lung Disease (ILD). Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy in the Same Surgical Stage.

Official Title

Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 23, 2018 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding 70 -80% . The aim of this study is to compare and analyze the diagnostic yield, for ILD, and complications following SLB and TC Methods. The investigators designed a descriptive, comparative and cross-sectional study in patients with ILD, in which SLB and CT will be performed in the same surgical stage, as diagnostic tests. This study will be conducted from January 2018 to January 2019. Surgical lung biopsy and TC will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. First TC will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a SLB. The samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features. Diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases, Interstitial

Keywords

Interstitial lung disease, cryobiopsy, surgical biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lung biopsy

Arm Type

Other

Arm Description

Lung biopsy

Intervention Type

Procedure

Intervention Name(s)

Lung biopsy

Other Intervention Name(s)

Cryobiopsy

Intervention Description

Each patient will be brought to the operating room and will undergo cryobiopsy and surgical biopsy of the lung sequentially in the same surgical stage.

Primary Outcome Measure Information:

Title

Quality of the tissue sample reported by the pathologist.

Description

comparison of diagnostic yield of cryobiopsy versus surgical lung biopsy according to the quality of the tissue sample reported by the pathologist.

Time Frame

for statistical analysis, 12 months after the first inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach. Subject provides informed consent. A negative pregnancy test in women of child-bearing potential. Subject is mentally capable of understanding study procedures. 18 years and older. Exclusion Criteria: Study subject has any disease or condition that interferes with safe completion of the study including: Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure. Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements Concurrent participation in another study involving investigational drugs or investigational medical devices Inability to read and understand the necessary study documents

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alejandra Libreros Niño, MD

Phone

+34628296229

LIBREROS@clinic.cat

Facility Information:

Facility Name

Hospital Clinic

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandra Libreros Niño, M.D.

Phone

+34628296229

LIBREROS@clinic.cat

First Name & Middle Initial & Last Name & Degree

Alejandra Libreros Niño

Phone

+34628296229

LIBREROS@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD

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Results Reference

result

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Interstitial Lung Disease (ILD). Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy in the Same Surgical Stage.

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