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

NCT ID: NCT05164445

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-08-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Transbronchial forceps biopsy

Patients, whose transbronchial forceps biopsy was performed

Group Type: ACTIVE_COMPARATOR

Transbronchial forceps biopsy

Intervention Type: DIAGNOSTIC_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 cryobiopsy

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

Group Type: ACTIVE_COMPARATOR

Transbronchial forceps biopsy+Transbronchial cryobiopsy

Intervention Type: DIAGNOSTIC_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)

Interventions

Transbronchial forceps biopsy

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.

Intervention Type: DIAGNOSTIC_TEST

Transbronchial forceps biopsy+Transbronchial cryobiopsy

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Marius Zemaitis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lithuanian University of Health Sciences

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

RIPMIRLC-001

Identifier Type: -

Identifier Source: org_study_id