Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy

NCT ID: NCT01892501

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-08
• Study Completion Date: 2019-10-10

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.

Conditions

Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

hypermetabolic mediastinal lymph nodes in PET,

hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.

Group Type: OTHER

Guided punction of mediastinal lymphadenopathy by echoendoscopy

Intervention Type: PROCEDURE

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.

PET scan

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: PROCEDURE

PET scan

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Insitut Bergonie

Bordeaux, Grionde, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 35341993 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IB 2012-01

Identifier Type: -

Identifier Source: org_study_id