Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients

Mediastinal Diseases Clinical Trial

— MED-HEM  

Official title:

Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients With Mediastinal Mass Syndrome Admitted to the Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694806
• Other study ID #: RC31/22/0237
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Toulouse
• Contact: Muriel Picard, MD
• Phone: 0561756105
• Email: picard.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Mediastinal Diseases

Intervention

Other:
• analysis of thoracic scans
analysis of thoracic scans realised in standard care

Locations

Country	Name	City	State
France	Muriel Picard	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify prognostic thoracic scan factors of severe mediastinal mass syndrome	To identify prognostic thoracic scan factors of severe mediastinal mass syndrome defined by the occurrence of severe respiratory, hemodynamics and/or neurological failures.	1 week