Clinical trial NCT05694806: Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients
Official title: Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients with Mediastinal Mass Syndrome Admitted to the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mediastinal Diseases
Keywords: Mediastinal mass syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 125
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with eligibility criteria hospitalised during the study period 01/01/2014 - 31/12/2021

Brief summary: The mediastinum can be the site of benign or malignant tumors, including 10 to 20% of hematological malignancies.

Mediastinal mass syndrome (MMS) includes symptoms due to irritation, invasion or compression of the organs of the mediastinum. This syndrome includes respiratory manifestations that may be secondary to compression of the tracheobronchial tree, venous vascular manifestations with the superior vena cava syndrome or arterial manifestations, cardiac manifestations, digestive or nervous manifestations.

The management of a mediastinal syndrome is a diagnostic and therapeutic emergency requiring the collaboration of several disciplines in order to achieve the most effective but least deleterious way possible to diagnostic imaging, etiological biopsy, and the possible implementation of life-saving symptomatic measures before the initiation of etiological treatment.

Diagnostic thoracic imaging relies primarily on thoracic computed tomography (CT) to determine the size and nature of the mediastinal mass, the presence and extent of tracheobronchial or great vessel compression, the presence of pleural and/or pericardial effusion, pulmonary embolism, parenchymal lesions, and possibly subdiaphragmatic lesions.

However, the potential severity of MMS is often under-diagnosed in adult patients, particularly in the context of hematologic malignancy. Indeed, we have very little literature on the initial management of these patients at risk.

The present study propose to conduct the first multicenter study to analyze the characteristics (clinical, scanographic, echocardiographic, hematological and resuscitation) of the initial management of patients with symptomatic MMS at diagnosis or at relapse of a patient with MH admitted to the Intensive Care Unit (ICU).


Eligibility criteria: Inclusion Criteria:

* Hematologic malignancy at diagnosis or relapse
* Symptomatic mediastinal mass syndrome
* Admission to the ICU, Continuous Medical Surveillance (CMS) or Intensive Care (IC) for symptomatology related to MMS
* Chest CT (after maximum 48 hours of corticosteroid therapy (1mg/kg/ Prednisone equivalent), maximum 15 days before and 5 days after admission to ICU)
* Maximum administration of corticosteroid therapy 48 hours before admission to the ICU (maximum 1mg/kg/ Prednisone equivalent)
* No prior pleural or pericardial drainage
* Study period: 01/01/2014 - 31/12/2021 (8 years)

Exclusion Criteria:

* No diagnosis of hematologic malignancy
* Diagnosis of solid benign or malignant tumor
* No mediastinal mass syndrome
* No admission to ICU/CMS
* No chest CT scan meeting inclusion criteria
* Administration of corticosteroids for more than 48 hours prior to admission to the ICU and/or prior to chest CT
* Lack of social security affiliation.

Primary outcomes:
measure: To identify prognostic thoracic scan factors of severe mediastinal mass syndrome
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Muriel Picard
Study officials:
affiliation: University Hospital, Toulouse
name: Muriel Picard, MD
role: PRINCIPAL_INVESTIGATOR
References: