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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
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.
In this second experimental group, the same medical devices are used but in the other order.
Pneumologie Elsan Santé Atlantique
Saint-Herblain, France
Validity of samples by cryoprobes
Histological diagnosis from the material collected by cryoprobes and conventional forceps
Time frame: Within 24 hours after intervention
Specificity, sensitivity, and predictive values of each technique
specificity, sensitivity, predictive values
Time frame: Within 24 hours after intervention
Tolerance and safety of the samples taken
Collection of adverse events for the duration of the study.
Time frame: 15 Days after intervention
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