Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules

NCT05230992 | Completed

• 2 other identifiers: CRYOPROBE2021-A01209-32
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult. There are 2 techniques: transthoracic puncture-biopsy under CT scan, usually performed by radiologists, and distal sampling guided by radial ultrasound mini-probe. The limitations of the last technique could be overcome by the use of cryoprobes for sampling, as they would take more tissue by freezing.

Conditions

Nodule

Outcome Measures

Primary Outcomes (1)

• Validity of samples by cryoprobes

  Histological diagnosis from the material collected by cryoprobes and conventional forceps

  Within 24 hours after intervention

Secondary Outcomes (2)

• Specificity, sensitivity, and predictive values of each technique

  Within 24 hours after intervention

• Tolerance and safety of the samples taken

  15 Days after intervention

Study Arms (2)

Cryoprobes First

EXPERIMENTAL

Use of cryoprobes and then conventional forceps during the same operating time.

Device: Cryoprobes First

Cryoprobes Second

EXPERIMENTAL

Use of conventional forceps and then cryoprobes during the same operating time.

Device: Cryoprobes Second

Interventions

Cryoprobes First DEVICE

In this experimental group, the Cryoprobe is used in first and the classic biopsy forceps in a second time. This medical device under study is the flexible, single-use Cryoprobe, supplied in sterile condition, 1.1 mm in diameter, 1150 mm long, with extraction tube, 817 mm long (reference 20402-401), or 757 mm long (reference 20402-402) marketed. These cryoprobes are covered by a CE marking. Cryoprobes must be used in conjunction with the Erbecryo®2 device and its accessories.

Cryoprobes First

Cryoprobes Second DEVICE

In this second experimental group, the same medical devices are used but in the other order.

Cryoprobes Second

Eligibility Criteria

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

You may qualify if:

• Patient with a tumor of any location with a draining bronchus (primary lung cancer or lung metastases)
• Suspected lung nodule(s) with anatomical situation on mid 1/3 CT
• Presence of at least one lung nodule of sufficient size on CT to allow for at least 8 tissue samples
• Male or female aged ≥ 18 years
• Mandatory membership in a health insurance plan
• Patient who has been informed about the study and has signed the informed consent form

You may not qualify if:

• Proximal or distal pulmonary nodule(s)
• Pacemaker patient
• Pregnant or nursing women
• Patients under legal protection

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Pneumologie Elsan Santé Atlantique

Saint-Herblain, 44800, France

Location

Related Publications (6)

• Dhooria S, Sehgal IS, Aggarwal AN, Behera D, Agarwal R. Diagnostic Yield and Safety of Cryoprobe Transbronchial Lung Biopsy in Diffuse Parenchymal Lung Diseases: Systematic Review and Meta-Analysis. Respir Care. 2016 May;61(5):700-12. doi: 10.4187/respcare.04488. Epub 2016 Mar 1.

  PMID: 26932382 BACKGROUND

• Hagmeyer L, Theegarten D, Treml M, Priegnitz C, Randerath W. Validation of transbronchial cryobiopsy in interstitial lung disease - interim analysis of a prospective trial and critical review of the literature. Sarcoidosis Vasc Diffuse Lung Dis. 2016 Mar 29;33(1):2-9.

  PMID: 27055830 BACKGROUND

• Montufar F, Moral LD, Labarca G, Folch E, Majid A, Fernandez-Bussy S. [Transbronchial cryobiopsies and cryotherapy in lung diseases]. Rev Med Chil. 2018 Sep;146(9):1033-1040. doi: 10.4067/s0034-98872018000901033. Spanish.

  PMID: 30725025 BACKGROUND

• Gershman E, Fruchter O, Benjamin F, Nader AR, Rosengarten D, Rusanov V, Fridel L, Kramer MR. Safety of Cryo-Transbronchial Biopsy in Diffuse Lung Diseases: Analysis of Three Hundred Cases. Respiration. 2015;90(1):40-6. doi: 10.1159/000381921. Epub 2015 May 20.

  PMID: 25998966 BACKGROUND

• Schumann C, Hetzel J, Babiak AJ, Merk T, Wibmer T, Moller P, Lepper PM, Hetzel M. Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions. J Thorac Cardiovasc Surg. 2010 Aug;140(2):417-21. doi: 10.1016/j.jtcvs.2009.12.028. Epub 2010 Mar 11.

  PMID: 20226474 BACKGROUND

• Hetzel J, Eberhardt R, Herth FJ, Petermann C, Reichle G, Freitag L, Dobbertin I, Franke KJ, Stanzel F, Beyer T, Moller P, Fritz P, Ott G, Schnabel PA, Kastendieck H, Lang W, Morresi-Hauf AT, Szyrach MN, Muche R, Shah PL, Babiak A, Hetzel M. Cryobiopsy increases the diagnostic yield of endobronchial biopsy: a multicentre trial. Eur Respir J. 2012 Mar;39(3):685-90. doi: 10.1183/09031936.00033011. Epub 2011 Aug 18.

  PMID: 21852332 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a clinical investigation of a CE (Communauté Européenne)-marked medical device that is monocentric, interventional, prospective, comparative, randomized, open-label, with cross-over design.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: February 9, 2022
• Study Start: November 5, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)