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

Lung Cancer Clinical Trial

— RIPMIRLC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164445
• Other study ID #: RIPMIRLC-001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 31, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• 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.
• 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)

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		one year after enrolment to the study
Secondary	overall survival		3 years after enrolment to the study