Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

May 25, 2022 updated by: Stefano Gasparini

Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial

This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

142 patients with at least one peripheral pulmonary nodule will be enrolled. They will underwent randomization in 2 arms: patients in the first arm will undergo transbronchial needle aspiration with a conventional bronchoscope patients in the second arm will undergo transbronchial needle aspiration with a ultra-thin bronchoscope. Every bronchoscopy will be performed by the same operator and will contemplate 3 passes for each nodule, followed by Rapid On-Site Evaluation (ROSE) assessed by a dedicated cytologist. If the cytological on-site evaluation is negative in patients in the first arm, they will be shifted to the second arm. Histological and molecular diagnosis will be assessed by a dedicated pathologist. Data will be collected and analyzed.

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 18years;
  • presence of at least one peripheral pulmonary lesion ≤ 3 cm on CT scan;
  • ability to give an informed consent.

Exclusion Criteria:

  • coagulopathy or bleeding diathesis that cannot be corrected;
  • severe refractory hypoxemia;
  • unstable hemodynamic status;
  • inability to give an informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TBNA with Conventional bronchoscope
patients in this arm will undergo bronchoscopy by a conventional probe
Device: Lung biopsy
Transbronchial Needle Aspiration performed via a ultra thin bronchoscope
Experimental: TBNA with a Ultrathin bronchoscope
Patients in this arm will undergo bronchoscopy by a ultra thin probe
Device: Lung biopsy
Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm
Time Frame: through study completion, an average of 6 months
percentage
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess if diagnostic yield is higher in the "ultrathin" arm than in the "conventional" arm
Time Frame: through study completion, an average of 6 months
percentage
through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess if sensitivity is similar in both arms
Time Frame: through study completion, an average of 6 months
percentage
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefano Gasparini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

July 18, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UTB2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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