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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsy; Diagnostic Test: Transbronchial forceps biopsy

• Registration Number: NCT05164445
• Lead Sponsor: Lithuanian University of Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-20
• Primary Completion: 2023-02-01
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transbronchial forceps biopsy+Transbronchial cryobiopsy	Transbronchial forceps biopsy+Transbronchial cryobiopsy	Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well
Transbronchial forceps biopsy	Transbronchial forceps biopsy	Patients, whose transbronchial forceps biopsy was performed

Primary Outcome Measures

Name	Time	Method
progression-free survival	one year after enrolment to the study

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years after enrolment to the study

Trial Locations

Locations (1)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania