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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT01892501
First received: June 26, 2013
Last updated: July 25, 2013
Last verified: July 2012
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Sensitivity of EUS-guided puncture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary endpoint is the performance of endoscopic ultrasound-guided puncture after detection of lymph nodes with PET. The performance of EUS guided biopsy will be evaluated in terms of sensitivity. In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury. 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.


Secondary Outcome Measures:
  • Negative predictive value [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    The negative predictive value of EUS guided biopsy will be evaluated. It is the rate of subjects with a diagnosis of benign pathology according the gold standard among all subjects for wich EUS reveal a benign pathology (excluding atypical/suspects findings or non contributory)

  • Impact of the management of patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    The impact will be assessed in two ways :

    • The clinical utility (avoid more invasive procedure)
    • Matching between therapeutic strategies RCP1/RCP2.


Other Outcome Measures:
  • Side effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In all cases the side effects associated with the implementation of the guided puncture EUS will be collected and classified according to the classification of surgical complications of Clavien-Dindo [P Clavien and al. Ann Surg 2009, 250: 187-96]


Enrollment: 24
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 thoracoabdominopelvien 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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-centimenter lymph node short axis: greater result than or equal to the background hepatic noise.
    • For sub-centimenter 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 structures recusantes)
  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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01892501

Locations
France
Insitut Bergonie
Bordeaux, Grionde, France, 33076
Sponsors and Collaborators
Institut Bergonié
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01892501     History of Changes
Other Study ID Numbers: IB 2012-01
Study First Received: June 26, 2013
Last Updated: July 25, 2013
Health Authority: France : French Office for the safety of health products

Keywords provided by Institut Bergonié:
Mediastinal lymphadenopathy
PET CT to 18FDG
EUS

Additional relevant MeSH terms:
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014