MED-HEM: Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05694806
Collaborator
(none)
125
1
12
10.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: analysis of thoracic scans

Study Design

Study Type:
Observational
Anticipated Enrollment :
125 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients With Mediastinal Mass Syndrome Admitted to the Intensive Care Unit
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
patients with symptomatic Mediastinal mass syndrome

patients with symptomatic Mediastinal mass syndrome at diagnosis or at relapse of a patient with haematological malignancy admitted to the Intensive Care unit

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

Outcome Measures

Primary Outcome Measures

  1. To identify prognostic thoracic scan factors of severe mediastinal mass syndrome [1 week]

    To identify prognostic thoracic scan factors of severe mediastinal mass syndrome defined by the occurrence of severe respiratory, hemodynamics and/or neurological failures.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Muriel Picard Toulouse France

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Muriel Picard, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05694806
Other Study ID Numbers:
  • RC31/22/0237
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023