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

Lithuanian University of Health Sciences

Status: Completed

Conditions: Lung Cancer

Treatments: Diagnostic Test: Transbronchial forceps biopsy; Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05164445

RIPMIRLC-001

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Transbronchial forceps biopsy

Active Comparator group

Description:

Patients, whose transbronchial forceps biopsy was performed

Treatment:

Diagnostic Test: Transbronchial forceps biopsy

Transbronchial forceps biopsy+Transbronchial cryobiopsy

Active Comparator group

Description:

Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well

Treatment:

Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsy