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Completed

NCT Number: NCT05164445

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences

Kaunas, LT 44307, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transbronchial forceps biopsy

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

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)

Primary outcomes

  1. progression-free survival

    Time frame: one year after enrolment to the study

Secondary outcomes

  1. overall survival

    Time frame: 3 years after enrolment to the study

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Acronym: RIPMIRLC

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2021
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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