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

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ClinicalTrials.gov Identifier: NCT01892501
Recruitment Status : Unknown
Verified November 2016 by Institut Bergonié.
Recruitment status was:  Recruiting
First Posted : July 4, 2013
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

Tracking Information
First Submitted Date  ICMJE June 26, 2013
First Posted Date  ICMJE July 4, 2013
Last Update Posted Date October 2, 2017
Actual Study Start Date  ICMJE March 8, 2013
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
Sensitivity of EUS-guided puncture [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01892501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • Negative predictive value [ Time Frame: 12 month ]
    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 ]
    The impact will be assessed in two ways :
    • The clinical utility (avoid more invasive procedure)
    • Matching between therapeutic strategies RCP1/RCP2.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2013)
Side effects [ Time Frame: 12 months ]
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]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Feasability Study on the Contribution of Guided Puncture With Echoendoscopy
Official Title  ICMJE 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)
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)
Intervention  ICMJE
  • 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
Study Arms  ICMJE hypermetabolic mediastinal lymph nodes in PET,
hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Interventions:
  • Procedure: Guided punction of mediastinal lymphadenopathy by echoendoscopy
  • Device: PET scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01892501
Other Study ID Numbers  ICMJE IB 2012-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Bergonié
Study Sponsor  ICMJE Institut Bergonié
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Bergonié
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP