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Hypoalbuminemia

Heart Diseases

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Patients with pleural effusion with an underlying aetiology of heart failure

Patients with pleural effusion with an underlying aetiology of fluid overload excluding heart failure

Patients with pleural effusion due to exudative, or non-fluid overload causes

Christopher Chan, MBChB

Ken KP Chan, MBChB

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Objective: To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Hypothesis to be tested: The PF NTproBNP levels are superior to existing methods including Light's criteria, serum/pleural fluid (S/PF) protein gradient, and albumin gradient, in identifying transudates and distinguishing between HF- and non-HF-associated PE.

Design and subjects: A prospective case-control study involving patients with PE requiring thoracentesis, caused by hypervolaemia due to HF, diseases other than HF, and patients with pleural effusion without hypervolaemia. Patient characteristics, PF results and effusion aetiology will be analysed. Patient outcomes will be followed up to 3 months to confirm the aetiology of PE. Clinical management of patients will not be affected.

Study instruments: PF of recruited patients will be analysed for albumin, protein, lactate dehydrogenase (LDH) levels and NTproBNP. The diagnosis of HF will be based on clinical features, serum NTproBNP and echocardiogram.

Main outcome measures: The performance of PF NTproBNP level in identifying HF-associated PE.

Data analysis: The PF NTproBNP level will be compared between effusions of different aetiologies. The optimal pleural fluid NTproBNP level with largest area under the receiver operating characteristic curve in identifying HF-associated PE will be determined. Performance of PF NTproBNP level in identifying HF-associated PE, and other biochemical criteria in identifying transudates will be compared. Echocardiographic findings will be correlated with the PF NTproBNP levels.

Expected results: The diagnostic performance of PF NTproBNP will be significantly better in identifying HF-associated effusion than other biochemical criteria.

Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis

Comparing N-terminal-proB-type Natriuretic Peptide With Other Diagnostic Criteria in Discriminating Heart Failure-associated From Non-heart Failure-associated Pleural Effusions

Given patient data and privacy concerns, clinical data involving individual patients will not be shared. Data summary tables may later be published along with the research manuscript, and may be shared upon receipt of a reasonable request.

Pleural fluid NTproBNP will be measured in patients with pleural effusion of various aetiologies including malignancy, pleural infection, heart failure and other causes of volume overload. The sensitivity and specificity of an elevated pleural fluid NTproBNP level in successfully identifying a pleural effusion due to underlying heart failure will be measured and compared against existing classification criteria for pleural effusion such as Light's Criteria, pleural-serum protein gradient or albumin gradient.

Clinical data of patients admitted to the hospital with pleural effusion will be measured and recorded. Statistical analysis will then be performed to evaluate for degree of correlation between the presence or severity of a clinical parameter, echocardiogram results e.g. severe valvular stenosis, or, e.g. presence of medical comorbidities or presence of concomitant infection, and the levels of NTproBNP identified in the patient's pleural fluid detected within same admission.

Roche Diagnostics GmbH

Chinese University of Hong Kong

Honorary Clinical Tutor

Neoplasms

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.

Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \> 5mm.

Therasphere 90Y

Microwave Ablation

Ken Bode

Amy Riehm

Ari Cohen, MD

This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.

This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin \< 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.

The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.

90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Randomized Study of Therapshere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm

Duration of time following the first cycle treatment until the targeted tumor requires additional treatment

Duration of time after first cycle treatment the target tumor continues to respond to treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis	NCT05797649	Pleural Effusio... Heart Failure Malignant Neopl... Fluid Overload Hypoalbuminemia Renal Failure Cirrhosis Infections		18 Years -	Chinese University of Hong Kong
90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia	NCT05953961	Carcinoma, Hepa...	Therasphere 90Y Microwave Ablat...	18 Years -	Ochsner Health System
Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis	NCT05797649	Pleural Effusio... Heart Failure Malignant Neopl... Fluid Overload Hypoalbuminemia Renal Failure Cirrhosis Infections		18 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for hypoalbuminemia