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Trial Title:
Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients
NCT ID:
NCT05694806
Condition:
Mediastinal Diseases
Conditions: Official terms:
Hematologic Neoplasms
Mediastinal Diseases
Conditions: Keywords:
Mediastinal mass syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
analysis of thoracic scans
Description:
analysis of thoracic scans realised in standard care
Arm group label:
patients with symptomatic Mediastinal mass syndrome
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).
Criteria for eligibility:
Study pop:
All patients with eligibility criteria hospitalised during the study period 01/01/2014 -
31/12/2021
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Muriel Picard
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Muriel Picard, MD
Start date:
June 1, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
University Hospital, Toulouse
Agency class:
Other
Source:
University Hospital, Toulouse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05694806
