Evolution of Indications for Transbronchial Ganglionic Ultrasound (EBUSPicardie)
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|ClinicalTrials.gov Identifier: NCT03132883|
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : August 2, 2018
|Condition or disease|
|Transbronchial Surgery Lymph Node Disease|
Transbronchial puncture is a technique known for many years with the first description found in 1949 by Shieppati. Subsequently, this technique allowing an exploration of the mediastinal lymph nodes became widespread with the work of Wang in 1983. However, the need to have exact knowledge of the different puncture sites in order to obtain maximum profitability with this examination in particular In staging and diagnosis in bronchopulmonary cancers (CBP) explains a significant difference in profitability between operators based on their experience. It was not until 1990 that Germans coupled the technique of radial ultrasound with that of bronchoscopy by introducing a balloon catheter inflated with a liquid allowing the best transmission of ultrasound. It is the German team of Herth who developed this technique in 1999 under the name of bronchial echo-endoscopy (EBUS). The association of echo-endoscopy before transbronchial punctures significantly improves the performance of the examination. In 2004, Yasufusu shows the interest of the real-time visualization of the lymph nodes for the marking as well as the punctures. Therefore, the indications for bronchial echoendoscopies with transbronchial needle puncture (EBUS-PTBA) are precisely defined in the nodal staging of CBP with good profitability and a reduction in surgical mediastinoscopy. Then, over time, there is an extension of indications with the diagnosis of Non-Small Cell Lung Broncho-Pulmonary Cancers (NSCLC) or Small Cell Broncho-Pulmonary Cancers (CBPC), the diagnosis of ganglion metastases of extra-thoracic primary tumors , Diagnosis of sarcoidosis or other more anecdotal uses (tuberculosis, lymphoma).
Two Picard centers were among the first in France to be equipped with echoendoscopes (2007 for the CH of Saint Quentin and 2008 for the CHU of Amiens). This allows our two centers to have a fairly consistent retreat on the technique since its implantation in France. While many studies are concerned with one or other indication in isolation, there is no study to the best of our knowledge relating the evolution over time of the respective share of each of these indications in daily practice . Given the current multiplication of potential indications for EBUS-PTBA, it seems interesting to analyze the place of these new indications in the daily activity of endoscopic centers equipped with an echo-endoscope. The main objective is to evaluate the respective share of each indication over time over the study period. Secondary objectives are the evaluation of the diagnostic performance of EBUS-PTBA, the evaluation of the abusively carried-out EBUS-PTBA (examination carried out for purely diagnostic purposes, whereas conventional bronchial fibroscopy Diagnosis of certainty) and evaluation of concordance between EBUS-PTBA and surgery in CBP staging indications.
|Study Type :||Observational|
|Actual Enrollment :||1036 participants|
|Official Title:||Evolution of Indications for Transbronchial Ganglionic Ultrasound in the Picardie Region Over the Period 2008 - 2013|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||April 30, 2017|
- Analysis of endoscopic examination (EBUS-PTBA): analysis of diagnosis and / or staging of bronchial carcinoma, diagnosis of sarcoidosis, tuberculosis, lymphoma, staging of extra-thoracic tumors [ Time Frame: 5 years ]Analysis of endoscopic examination (EBUS-PTBA): analysis of diagnosis and / or staging of bronchial carcinoma, diagnosis of sarcoidosis, tuberculosis, lymphoma, staging of extra-thoracic tumors
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132883
|CHU Amiens Picardie|
|Amiens, Picardie, France, 80054|
|Principal Investigator:||Damien BASILLE, Dr||CHU AMIENS PICARDIE|