Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use and Effectiveness of Balloon for Endobronchial Ultrasonography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04735094
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
Although balloons appear to improve ultrasound image quality, it's use can be technically difficult for segmental airways because of anatomical limitations to convex probe imaging. Furthermore, it is uncertain whether this leads to a better diagnostic yield. To our knowledge, there are currently no studies showing that the use of balloon improves diagnostic yield with EBUS. We hypothesize that the use of balloon may increase the diagnostic yield by improving ultrasound image quality and reduce the duration of the procedure.The aim of this study is to analyse whether the use of balloon during linear EBUS 1) improves diagnostic yield, 2) reduces the duration of the procedure, and 3) improves ultrasound image quality with increased operator satisfaction in terms of ease of procedure.

Condition or disease Intervention/treatment Phase
Lung Cancer Staging Diagnostic Test: Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Control Trial of the Use and Effectiveness of Balloon for Endobronchial Ultrasonography.
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : January 21, 2022
Estimated Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope Diagnostic Test: Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope
A small balloon made of latex can be attached to the tip of echo-bronchoscope which is then inflated with water or saline for better apposition of the echo-endoscope and the airway wall. This may improve ultrasound image quality and aid better visualization of the lymph nodes.

No Intervention: Endobronchial biopsy without the use of a balloon attached to the echo-bronchoscope



Primary Outcome Measures :
  1. Diagnostic yield [ Time Frame: 1 year ]
    Diagnostic yield will be calculated separately for each group with and without the use of balloon. Diagnostic yield will be defined as a satisfactory sample with presence of lymphocytes in the aspirate on the final pathology report. In order to minimise the confounding factor in diagnostic yield based on the dimensions of the LN, we chose a single LN station (4R) and patients were sub-dvided into 3 groups based on the size of the LN.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adults aged ≥18 years
  • Patient referred for EBUS guided TBNA of mediastinal LNs
  • The para-tracheal lymph node (LN) station 4R is planned to be biopsied.

Exclusion criteria

-Patient referred for EBUS and 4R is NOT planned to be biopsed


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735094


Contacts
Layout table for location contacts
Contact: Adeline Jouquan 5148908000 ext 26214 adeline.jouquan.chum@ssss.gouv.qc.ca

Locations
Layout table for location information
Canada, Quebec
CHUM Recruiting
Montréal, Quebec, Canada
Contact: Adeline Jouquan, MSc    514-890-8000 ext 26214    adeline.jouquan.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Layout table for additonal information
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04735094    
Other Study ID Numbers: CT0101
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No