Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.

NCT05257382 | Completed

• 1 other identifier: P2019/617
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

A monocentric prospective and randomized trial aiming to compare the diagnostic yield and safety of electromagnetical-guided bronchoscopy (ENB) procedures coupled to trans-bronchial lung cryobiopsies for the diagnosis of pulmonary nodule when performed either in a "standard" bronchoscopy suite or in a hybrid room with CBCT guidance and the use of the CrossCountry technique as required.

Conditions

Lung Cancer; Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  The primary outcome will be the comparison of the diagnostic yield obtained when ENB procedures will be performed on either the "classical " endoscopic suite or in the CBCT suite

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Rate of pneumothorax

  up to 1 month after the procedure

• Rate of bleeding

  up to 1 month after the procedure

• Duration of the interventions

  Up to one day after the procedure

Study Arms (2)

Endoscopy suite

ACTIVE COMPARATOR

In this arm, ENB procedure will be performed in a classical endoscopy suite equipped by a fluoroscopy.

Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy

CBCT suite

EXPERIMENTAL

In this arm, ENB procedure will be performed in a n hybrid room equipped by a cone beam CT (CBCT). This will allow to perform a real time visualisation of the lesion, enhanced fluoroscopy and to use the CrossCountry technique if required.

Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy

Interventions

ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy PROCEDURE

After having performed the ENB procedure to reach the identified lung lesion, biopsies will be performed (six forceps trans-bronchial biopsies and one trans-bronchial lung cryobiopsy)

CBCT suite; Endoscopy suite

Eligibility Criteria

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

You may qualify if:

• Pulmonary nodule of maximum 30mm of largest diameter
• Nodules can be either solid or subsolid (including GGO) without evidence of loco-regional or distant metastasis that could be biopsied, and no evidence for an infectious underlying disease.

You may not qualify if:

• Patient eligible for a direct surgical resection of the nodule

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Hopital Erasme

Brussels, 1070, Belgium

Location

Related Publications (1)

• Bondue B, Taton O, Tannouri F, Van de Velde N, Remmelink M, Leduc D. High diagnostic yield of electromagnetic navigation bronchoscopy performed under cone beam CT guidance: results of a randomized Belgian monocentric study. BMC Pulm Med. 2023 May 27;23(1):185. doi: 10.1186/s12890-023-02492-7.

  PMID: 37245012 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Benjamin Bondue, PhD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chest physician - MD PhD

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 25, 2022
• Study Start: February 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the publication of the results
• Access Criteria: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

Locations

BE (1)