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

Observational Participants Not Assigned to Intervention(s) Based on a Protocol; Typically in Context of Routine Care

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05164445

Acronym

RIPMIRLC

Enrollment

200

Registered

2021-12-20

Start date

2019-09-01

Completion date

2023-08-31

Last updated

2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

cryobiopsy, lung cancer, gut-lung microbiota, immune system

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.

Interventions

DIAGNOSTIC_TESTTransbronchial 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.

DIAGNOSTIC_TESTTransbronchial 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame
progression-free survival	one year after enrolment to the study

Secondary

Measure	Time frame
overall survival	3 years after enrolment to the study

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026