NCT01892501

Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-01-08
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2013-07-04
• Last updated: 2025-09-03
• Results posted: 2021-04-27

Locations

1 site across 1 country: France