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

NCT05164445 | Completed

• 1 other identifier: RIPMIRLC-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  one year after enrolment to the study

Secondary Outcomes (1)

• overall survival

  3 years after enrolment to the study

Study Arms (2)

Transbronchial forceps biopsy

ACTIVE COMPARATOR

Patients, whose transbronchial forceps biopsy was performed

Diagnostic Test: Transbronchial forceps biopsy

Transbronchial forceps biopsy+Transbronchial cryobiopsy

ACTIVE COMPARATOR

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

Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsy

Interventions

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 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)

Transbronchial forceps biopsy+Transbronchial cryobiopsy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT 44307, Lithuania

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 20, 2021
• Study Start: September 1, 2019
• Primary Completion: February 1, 2023
• Study Completion: August 31, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

LI (1)