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

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine250 enrolled

Overview

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

一) Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria: 1. lung infiltration detection at computed tomography (CT) scan. 2. 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 1. classic microbiological cultures designed for bacteria, fungi, and mycobacteria. 2. Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit. 3. Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method. 4. Cytological and pathogenic microscopic evaluation in BALF 5. Flow cytological analysis of T lymphocyte subsets in BALF and serum 6. Cytokine detection in BALF and serum 7. Microbiology detection in BALF by mNGS 三) Pathogenic spectrum analysis and Targeted etiological therapy

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Bronchoalveolar Lavage Fluid Lung Infection

Interventions

Bronchoscopic Alveolar LavageDIAGNOSTIC_TEST

The diagnostic yield of different diagnostic methods for lung infection and non-infectious diseases under allo-HSCT patients. 1. Classic microbiological cultures designed for bacteria, fungi, and mycobacteria. 2. Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit. 3. Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method. 4. Cytological and pathogenic microscopic evaluation in BALF 5. Flow cytological analysis of T lymphocyte subsets in BALF and serum 6. Cytokine detection in BALF and serum 7. Microbiology detection in BALF by mNGS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with hematological diseases. 2. Recipients of allogeneic peripheral blood stem cell transplantation. 3. Lung infiltration detection at computed tomography (CT) scan. 4. Patients with fever, cough, respiratory symptoms. 5. Consent to BAL and follow-up observation after BAL Exclusion Criteria: 1. Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction; 2. Multiple bullae are at risk of rupture; 3. Untreated patients with active pulmonary tuberculosis; 4. Patients with severe consumptive diseases or conditions and various causes can not cooperate well 5. Cardiac insufficiency, severe pulmonary ventilation dysfunction 6. Recent massive hemoptysis 7. Aortic aneurysm and esophageal varices are at risk of rupture

Outcomes

Primary Outcomes

overall response rate

Efficiency of treatment for pulmonary complications after allo-HSCT

Time frame: 100 days after BAL

Secondary Outcomes

microbiology diagnostic yields

Comparing the pathogenic detection rate by BALF with non-invasive detection method

Time frame: 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

Time frame: 30-day and 100-day after BAL

Central Contacts

xianmin song, M.D.

CONTACT

86-21-37798987 shongxm@139.com

su li

CONTACT

86-21-37798987 lisuabcd@126.com

Data from ClinicalTrials.gov

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