Status:
COMPLETED
Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy
Lead Sponsor:
Institut Bergonié
Conditions:
Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Impact of screening nodes mediastinal by PET, at different times of the management of cancer disease, remain unclear. Benefits of combined PET and puncture with echoendoscopy for the diagnosis subseq...
Detailed Description
Main objective : Assess the performance (in terms of sensitivity) of guided punction by echoendoscopy in the characterization of hypermetabolic mediastinal lymph nodes in PET, in a context of New can...
Eligibility Criteria
Inclusion
- Any patients who have had PET showing one or more hypermetabolic lymphadenopathy in middle mediastinum and/or lower and/or posterior, and requiring diagnostic certainty for support.
- PET scans performed in these particulars :
- Pre-treatment assessment of thoracic or extra-thoracic malignancies (patients without a history of cancer).
- Evaluation of response to treatment referred to oncological.
- Suspicion of relapse in patients with a personal history of thoracic or extra-thoracic malignancies.
- PET, the result is positive :
- For above-centimeter lymph node short axis: greater result than or equal to the background hepatic noise.
- For sub-centimeter lymph node small axis : greater result than the background hepatic noise
- Patient with indication of diagnostic procedure surgically (whether realized or not)
- Lymph node(s) available(s) puncture by EUS esophageal, so for a technically feasible for esophageal puncture (without vascular recusants structures)
- Age ≥ 18 years.
- PET scan performed within 6 weeks before EUS
- Platelets ≥ 70 000/mm3; TP ≥ 60%.
- Patient of childbearing age with negative pregnancy test and / or a contraception.
- Patient gave informed consent signed.
- Patient affiliated to a social security scheme.
Exclusion
- Contra-indication (s) Director (s) to achieve a EUS.
- Balance adverse anesthetic (not allowing a general anesthetic).
- Esophageal stenosis.
- Coagulation disorders.
- Pregnant or lactating women.
- Unable to undergo medical monitoring test for geographical, social or psychological reasons.
- Private patient freedom and major subject of a measure of legal protection or unable to consent.
Key Trial Info
Start Date :
January 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01892501
Start Date
January 8 2013
End Date
October 10 2019
Last Update
September 3 2025
Active Locations (1)
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1
Insitut Bergonie
Bordeaux, Grionde, France, 33076