N/A
N=75
Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy
Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)
Bottom Line
View on ClinicalTrials.gov: NCT01892501 ↗Enrolled (actual)
75
Serious AEs
72.3%
Results posted
Apr 2021
Primary outcome: Primary: Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture — 93 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Guided punction of mediastinal lymphadenopathy by echoendoscopy (Procedure); PET scan (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture |
93 | — |
| SECONDARY Negative Predictive Value |
90 | — |
| SECONDARY Matching Between Therapeutic Strategies RCP1/RCP2 |
44.7 | — |
| SECONDARY Clinical Utility (Avoid More Invasive Procedure) |
95.7 | — |
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 subsequent therapeutic management should be evaluated in these different contexts.
We would like to demonstrate the clinical utility of this association to replace more invasive diagnostic procedures and to assess the impact of the puncture on a possible modification of the therapeutic management.
It is a single center prospective diagnostic assessment
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01892501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.