The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer

Lithuanian University of Health Sciences200 enrolled

Overview

This study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

200

Conditions

Lung Cancer

Interventions

Transbronchial forceps biopsyDIAGNOSTIC_TEST

All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and mini probe endobronchial ultrasound (RP-EBUS) scans were enrolled. Transbronchial forceps biopsy (TBFB) was performed for all these patients.

Transbronchial forceps biopsy+Transbronchial cryobiopsyDIAGNOSTIC_TEST

All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans were enrolled. TBFB was performed for all these patients. In addition, all of these patients, with no contraindications, underwent transbronchial cryobiopsy (TBCB)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans * Control group - patients without non-small cell lung cancer * Written (signed) Informed Consent to participate in the study Exclusion Criteria: * severe hypoxemia (partial pressure of oxygen (pO2)\< 60 mmHg) or hypercapnia (carbon dioxide partial pressure (pCO2)\> 50 mmHg), * bleeding disorders * The diffusing capacity for carbon monoxide (DLCOc)\< 35 %, * forced expiratory volume in one second (FEV1) \< 800 ml or FEV 1 \< 30 %, * peripheral lung tumor was not visualised by RP-EBUS longer than 30 minutes * large vessels (more than 3 mm) near the tumor on the CT scan, * technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment, * excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.

Locations (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Outcomes

Primary Outcomes

progression-free survival

Time frame: one year after enrolment to the study

Secondary Outcomes

overall survival

Time frame: 3 years after enrolment to the study

Data from ClinicalTrials.gov

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