Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evolution of Indications for Transbronchial Ganglionic Ultrasound (EBUSPicardie)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03132883
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
New indications for bronchial echo-endoscopies with transbronchial needle aspiration (EBUS-PTBA) have appeared since the first French centers with this technique were fitted. Evaluate the respective share of each indication of EBUS-AWPB over time over the period 2008 - 2013

Condition or disease
Transbronchial Surgery Lymph Node Disease

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 1036 participants
Observational Model: Cohort
Time Perspective: Retrospective
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inclusive patients will be made from the computer database of endoscopy services of each of the 2 centers listing endoscopic examinations carried out over the period of interest
Criteria

Inclusion Criteria:

  • Patients who underwent a first linear echo-endoscopy at the CHU of Amiens and the CH of Saint-Quentin between January 2008 and December 2013

Exclusion Criteria:

  • Patient sent by a center outside Picardie
  • Patient having expressed a refusal to participate in the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132883


Locations
Layout table for location information
France
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Principal Investigator: Damien BASILLE, Dr CHU AMIENS PICARDIE

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03132883     History of Changes
Other Study ID Numbers: RNI2016-41 Dr Basille-2
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No