Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules (CRYOPROBE)
Primary Purpose
Nodule
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cryoprobes First
Cryoprobes Second
Sponsored by
About this trial
This is an interventional diagnostic trial for Nodule
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Proximal or distal pulmonary nodule(s)
- Pacemaker patient
- Pregnant or nursing women
- Patients under legal protection
Sites / Locations
- Pneumologie Elsan Santé AtlantiqueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cryoprobes First
Cryoprobes Second
Arm Description
Use of cryoprobes and then conventional forceps during the same operating time.
Use of conventional forceps and then cryoprobes during the same operating time.
Outcomes
Primary Outcome Measures
Validity of samples by cryoprobes
Histological diagnosis from the material collected by cryoprobes and conventional forceps
Secondary Outcome Measures
Specificity, sensitivity, and predictive values of each technique
specificity, sensitivity, predictive values
Tolerance and safety of the samples taken
Collection of adverse events for the duration of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05230992
Brief Title
Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules
Acronym
CRYOPROBE
Official Title
Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules Using Cryoprobes Versus Standard Biopsy Forceps During Distal Sampling Guided by Mini Radial Ultrasound Probes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Concerning the interventional pneumology technique, it is performed in two steps: identification of the mass with the mini ultrasound probe and then distal sampling with a small biopsy forceps. Experience shows that there is a significant difference between the identification of the mass, which is fairly conclusive, and the samples, which are much less productive (60% at best), because it is necessary that :
that the tumor is endo-bronchial,
that the forceps open sufficiently to take samples by back and forth movements
but, on the other hand, that the bronchus is not too wide.
The use of cryoprobes would allow to take more tissue by freezing. The target tissue freezes at the tip of the cryoprobe and can be detached by traction. The longer the freezing time, the more tissue is removed.
Various studies of endo-bronchial visible tumor diagnosis have compared these 2 sampling techniques (cryoprobe and conventional biopsy forceps). The cryoextraction technique performed by cryoprobes has a superior diagnostic yield (compared to flexible forceps biopsy) due to large biopsies and superior quality of the biopsied tissue (very few crush artifacts or hematomas; the morphological structure remains intact).
In this context, it seems interesting to compare these 2 techniques but in distal situation, under ultrasound detection with the mini-probes, for tumors not visible in endo-bronchial. The first samples taken in the investigating center by this technique are convincing.
In the framework of this study, in the same operating time and after ultrasound identification of the tumor, biopsies will be performed by conventional forceps (5 samples) and by cryoprobes (3 samples) on the same site. The sequence of use of one or the other technique will be randomly selected. Thus, each patient is his own control.
This first pilot study will explore the feasibility, effectiveness and safety of this procedure. Depending on the results of this comparative study, a second study including more patients will validate this procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nodule
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryoprobes First
Arm Type
Experimental
Arm Description
Use of cryoprobes and then conventional forceps during the same operating time.
Arm Title
Cryoprobes Second
Arm Type
Experimental
Arm Description
Use of conventional forceps and then cryoprobes during the same operating time.
Intervention Type
Device
Intervention Name(s)
Cryoprobes First
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cryoprobes Second
Intervention Description
In this second experimental group, the same medical devices are used but in the other order.
Primary Outcome Measure Information:
Title
Validity of samples by cryoprobes
Description
Histological diagnosis from the material collected by cryoprobes and conventional forceps
Time Frame
Within 24 hours after intervention
Secondary Outcome Measure Information:
Title
Specificity, sensitivity, and predictive values of each technique
Description
specificity, sensitivity, predictive values
Time Frame
Within 24 hours after intervention
Title
Tolerance and safety of the samples taken
Description
Collection of adverse events for the duration of the study.
Time Frame
15 Days after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Proximal or distal pulmonary nodule(s)
Pacemaker patient
Pregnant or nursing women
Patients under legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Yves JASNOT, MD
Phone
(0)607610175
Ext
+33
Email
jy.jasnot@gmail.com
Facility Information:
Facility Name
Pneumologie Elsan Santé Atlantique
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Yves JASNOT, MD
Phone
(0)607610175
Ext
+33
Email
jy.jasnot@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26932382
Citation
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.
Results Reference
background
PubMed Identifier
27055830
Citation
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.
Results Reference
background
PubMed Identifier
30725025
Citation
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.
Results Reference
background
PubMed Identifier
25998966
Citation
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.
Results Reference
background
PubMed Identifier
20226474
Citation
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.
Results Reference
background
PubMed Identifier
21852332
Citation
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.
Results Reference
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Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules
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