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Transbronchial SurgeryEBUSPicardieNCT03132883

Evolution of Indications for Transbronchial Ganglionic Ultrasound

An observational study of Transbronchial Surgery and Lymph Node Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transbronchial Surgery, Lymph Node Disease
How many people
1,036 participants
Where
1 siteFrance
Study dates
1 Feb 2017to 30 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Amiens Picardie

    Amiens, Picardie, 80054

Other trials in France

About this study

Official title: Evolution of Indications for Transbronchial Ganglionic Ultrasound in the Picardie Region Over the Period 2008 - 2013

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

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study start1 Feb 2017
  3. Primary completion30 Apr 2017
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,036 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03132883
Sponsor's protocol ID
RNI2016-41 Dr Basille-2
Acronym
EBUSPicardie
Status last verified
Jul 2018
First submitted
14 Apr 2017
Last updated
2 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Transbronchial Surgery and Lymph Node Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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