Diagnosis of Lung Complication After Allo-HSCT by Multiple Parameter System Through BAL

Study Overview
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Brief Summary
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The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.

Detailed Description
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一) Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria: lung infiltration detection at computed tomography (CT) scan. Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible 二) The BALF samples were tested using such methods classic microbiological cultures designed for bacteria, fungi, and mycobacteria. Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit. Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method. Cytological and pathogenic microscopic evaluation in BALF Flow cytological analysis of T lymphocyte subsets in BALF and serum Cytokine detection in BALF and serum Microbiology detection in BALF by mNGS 三) Pathogenic spectrum analysis and Targeted etiological therapy

Official Title
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Diagnosis of Lung Complication After Allogeneic Hematopoietic Stem Cell Transplantation by Multiple Parameter System Through Bronchoscopic Alveolar Lavage

Conditions
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Bronchoalveolar Lavage Fluid, Lung Infection

Intervention / Treatment
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* Diagnostic Test: Bronchoscopic Alveolar Lavage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with hematological diseases. Recipients of allogeneic peripheral blood stem cell transplantation. Lung infiltration detection at computed tomography (CT) scan. Patients with fever, cough, respiratory symptoms. Consent to BAL and follow-up observation after BAL Exclusion Criteria: Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction; Multiple bullae are at risk of rupture; Untreated patients with active pulmonary tuberculosis; Patients with severe consumptive diseases or conditions and various causes can not cooperate well Cardiac insufficiency, severe pulmonary ventilation dysfunction Recent massive hemoptysis Aortic aneurysm and esophageal varices are at risk of rupture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAL group<br>Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria: lung infiltration detection at computed tomography (CT) scan. Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible | Diagnostic Test: Bronchoscopic Alveolar Lavage<br>* The diagnostic yield of different diagnostic methods for lung infection and non-infectious diseases under allo-HSCT patients. Classic microbiological cultures designed for bacteria, fungi, and mycobacteria. Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit. Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method. Cytological and pathogenic microscopic evaluation in BALF Flow cytological analysis of T lymphocyte subsets in BALF and serum Cytokine detection in BALF and serum Microbiology detection in BALF by mNGS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | Efficiency of treatment for pulmonary complications after allo-HSCT | 100 days after BAL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiology diagnostic yields | Comparing the pathogenic detection rate by BALF with non-invasive detection method | 100 days after BAL | 
| all-cause mortality and attributable mortality of pulmonary complications | 30-day and 100-day mortality (including all-cause mortality and attributable mortality of pulmonary complications) in patients undergoing BAL | 30-day and 100-day after BAL | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Pneumonia Syndrome, CMV Pneumonia, Pneumocystis Jiroveci Pneumonia, Invasive Pulmonary Aspergillosis