Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Nodule

Intervention / Treatment
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* Device: Cryoprobes First
* Device: Cryoprobes Second


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoprobes First<br>Use of cryoprobes and then conventional forceps during the same operating time. | Device: Cryoprobes First<br>* 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.<br>|
| Experimental: Cryoprobes Second<br>Use of conventional forceps and then cryoprobes during the same operating time. | Device: Cryoprobes Second<br>* In this second experimental group, the same medical devices are used but in the other order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of samples by cryoprobes | Histological diagnosis from the material collected by cryoprobes and conventional forceps | Within 24 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity, sensitivity, and predictive values of each technique | specificity, sensitivity, predictive values | Within 24 hours after intervention | 
| Tolerance and safety of the samples taken | Collection of adverse events for the duration of the study. | 15 Days after intervention |