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Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy (APOGEE)

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ClinicalTrials.gov Identifier: NCT01892501
Recruitment Status : Completed
First Posted : July 4, 2013
Results First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

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


Condition or disease Intervention/treatment Phase
Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET) Procedure: Guided punction of mediastinal lymphadenopathy by echoendoscopy Device: PET scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : January 8, 2013
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019

Arm Intervention/treatment
hypermetabolic mediastinal lymph nodes in PET,
hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Procedure: Guided punction of mediastinal lymphadenopathy by echoendoscopy

EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.

Pathological samples are taken :

3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.


Device: PET scan
The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts




Primary Outcome Measures :
  1. Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture [ Time Frame: 12 months ]

    The performance of EUS-guided biopsy has been evaluated in terms of sensitivity. EUS-guided was performed after detection of lymph nodes with positron emission tomography (PET). In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury.

    PET, the reference technique (gold standard), is followed for 12 months. Sensitivity is the rate of subjects with a diagnosis of malignancy (excluding the results atypical / suspicious or non-contributory) according the results of EUS among all subjects with a neoplastic disease by the gold reference.

    To sum up , the sensitivity corresponds to the rate of patients detected as "malignant" with the new technique (EUS-guided), among the patients detected as "malignant" at the reference PET examination (12 months assessment).



Secondary Outcome Measures :
  1. Negative Predictive Value [ Time Frame: 12 months ]
    The negative predictive value of EUS-guided biopsy has been evaluated by the rate of subjects with a diagnosis of benign pathology according the gold standard (PET) among all subjects for wich EUS reveal a benign pathology (excluding atypical/suspects findings or non contributory)

  2. Matching Between Therapeutic Strategies RCP1/RCP2 [ Time Frame: 12 months ]

    Impact of the management of patient :

    Concordance between therapeutic strategies before the results of the endoscopy (Multidisciplinary consultation meeting 1 (RCP1) in absence of documentation) and after the results of endoscopy (Multidisciplinary consultation meeting 2 (RCP2) post-documentation) for the eligible and evaluable population


  3. Clinical Utility (Avoid More Invasive Procedure) [ Time Frame: 12 months ]

    The clinical utility of puncture under echo-endoscopy puncture has been considered to have a clinical utility, if it allows the patient to avoid more invasive diagnostic procedures (mediastinoscopy or thoracoscopy) or if it allows the patient to benefit from appropriate treatment (result of the malignant biopsy) or to avoid receiving unjustified treatment (result of the benign biopsy): case of patients well classified as malignant/benign by puncture under echo-endoscopy.

    The puncture will be considered to have no clinical utility if the result of the puncture under echo-endoscopy is invalidated by the reference examination, or if the result of the puncture does not allow a diagnosis to be made.



Other Outcome Measures:
  1. Side Effects - Number of Adverse Event Declared According to DINDO Classification [ Time Frame: 12 months ]

    In all cases the side effects associated with the implementation of the guided puncture EUS has been collected and classified according to the classification of surgical complications of Clavien-Dindo [P Clavien and al. Ann Surg 2009, 250: 187-96].

    Classification of surgical complications of Clavien-Dindo ranges from grade 1 (any deviation from the normal postoperative course) to grade 5 (death of patient)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT01892501


Locations
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France
Insitut Bergonie
Bordeaux, Grionde, France, 33076
Sponsors and Collaborators
Institut Bergonié
  Study Documents (Full-Text)

Documents provided by Institut Bergonié:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01892501    
Other Study ID Numbers: IB 2012-01
First Posted: July 4, 2013    Key Record Dates
Results First Posted: April 27, 2021
Last Update Posted: April 27, 2021
Last Verified: April 2021
Keywords provided by Institut Bergonié:
Mediastinal lymphadenopathy
PET CT to 18FDG
EUS
Additional relevant MeSH terms:
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Lymphadenopathy
Lymphatic Diseases