Clinical trial NCT01892501: Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy
Official title: Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy in Evaluation of Hypermetabolic Lymphadenopathy Mediastinum Lower, Rear and Middle, Detected in PET-CT to 18 FDG (PET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)
Keywords: Mediastinal lymphadenopathy
PET CT to 18FDG
EUS
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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

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 cancer or cancer recurrence.

Conduct of the study :

When a patient has had a PET scan showing a hypermetabolic or mediastinal lymph nodes in the lower, middle or posterior, his case is presented in a multidisciplinary meeting (PCR # 1), with definition of diagnostic strategy:

Approved indication is achieve a biopsy surgically to have a histological documentation of mediastinal lymph nodes with obvious impact on treatment decisions.

We distinguish two groups of patients based on the feasibility of the surgical procedure:

1. Group A biopsy is surgically feasible
2. Group B: biopsy by surgery can not be performed (against medical contraindications or anesthetics) at that moment, definition of therapeutic strategy that was decided in the absence of histological documentation:

   * Surgery outset
   * Chemotherapy or other oncological treatment
   * Supports non-oncological if benign disease suspected
   * No treatment.

EUS is performed by oesophageal for two patient groups for the two groups of patients (within a maximum period of six weeks after the PET scan), under general anesthesia and endoscopic control.

According the pathological findings, the therapeutic strategy is defined in a second PCR (PCR # 2), to assess the impact of the puncture:

* Surgery outset
* Chemotherapy or other oncological treatment
* Supports non-oncological when benign pathology documented
* No treatment
* Selecting another surgical diagnostic procedure (non-contributory income).

A patient monitoring will be conducted for 12 months. The clinical and radiological data carried over the standard of care of the patient will be collected. Achieving a thoracoabdominopelvic scanner (TAP) at 1 year to characterize the evolution of the disease marks the end of the study for the patient.

For the patients who have had a negative biopsy, monitoring will involve a scanner TAP 6 month and 12 month then consultation with the oncologist.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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
4. Patient with indication of diagnostic procedure surgically (whether realized or not)
5. Lymph node(s) available(s) puncture by EUS esophageal, so for a technically feasible for esophageal puncture (without vascular recusants structures)
6. Age ≥ 18 years.
7. PET scan performed within 6 weeks before EUS
8. Platelets ≥ 70 000/mm3; TP ≥ 60%.
9. Patient of childbearing age with negative pregnancy test and / or a contraception.
10. Patient gave informed consent signed.
11. 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.

Primary outcomes:
measure: Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture
timeFrame: 12 months
Secondary outcomes:
measure: Negative Predictive Value
timeFrame: 12 months
measure: Matching Between Therapeutic Strategies RCP1/RCP2
timeFrame: 12 months
measure: Clinical Utility (Avoid More Invasive Procedure)
timeFrame: 12 months
Other outcomes:
measure: Side Effects - Number of Adverse Event Declared According to DINDO Classification
timeFrame: 12 months
Locations:
city: Bordeaux
country: France
facility: Insitut Bergonie
state: Grionde
Study officials:
References:
citation: Bechade D, Bellera C, Gauquelin L, Soubeyran I, McKelvie-Sebileau P, Debled M, Chomy F, Roubaud G, Fonck M, Pernot S, Roch A, Cazeau AL. Diagnostic accuracy and clinical impact of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in Positron Emission Tomography - Computed Tomography (PET-CT)-positive mediastinal lymphadenopathies in patients with thoracic or extra-thoracic malignancies. Clin Res Hepatol Gastroenterol. 2022 May;46(5):101912. doi: 10.1016/j.clinre.2022.101912. Epub 2022 Mar 25.