Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy volunteers. The main questions it aims to answer are:

Do patients with cirrhosis show reduced diaphragmatic function compared to healthy adults?

Does removal of ascitic fluid by paracentesis improve diaphragmatic mechanics?

Can ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans?

Participants will:

Undergo diaphragmatic ultrasound during quiet and deep breathing

Provide clinical and laboratory data related to liver disease severity

In some cases, have ultrasound repeated before and after paracentesis

For patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years.

Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.

Ability to provide written informed consent in Arabic or English.

For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.

Disqualifiers

Significant pre-existing primary pulmonary disease (e.g., moderate-to-severe COPD defined as FEV1/FVC <70% with FEV1 <60% predicted, interstitial lung disease, pulmonary fibrosis) that independently affects diaphragmatic mechanics.

Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.

Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.

Active mechanical ventilation at time of enrollment.

Trial population

Adults (≥18 years of age) with confirmed diagnosis of liver cirrhosis attending the hepatology outpatient clinic or admitted to the hepatology inpatient unit of the study institution. Study Subgroups The total study sample will consist of 120 participants, including 95 patients with liver cirrhosis and 25 healthy controls. The cirrhotic cohort will include patients across different Child-Pugh classes and MELD scores and will encompass clinically relevant subgroups such as patients with ascites undergoing paracentesis, hepatic hydrothorax, and hepatocellular carcinoma (HCC). * Subgroup A: Ascites/Paracentesis (n=30): Patients with tense or refractory ascites for whom large-volume paracentesis is clinically indicated. This subgroup will contribute both cross-sectional and longitudinal (pre/post paracentesis) data. * Subgroup B: Hepatic Hydrothorax (n=40): Twenty patients with confirmed hepatic hydrothorax (HH; defined as pleural effusion \>500 mL in the absence of primary cardiopulm

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Adults with Liver Cirrhosis

Trial outcomes

Primary outcomes

1

Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm]

Diaphragmatic thickness at end-expiration (Tdi-exp) and end-inspiration (Tdi-insp) measured by B-mode ultrasound.

Time frame
Baseline (Day 1, at enrollment).
2

Diaphragmatic Thickening Fraction (TF) [%]

Thickening fraction calculated as \[(Tdi-insp - Tdi-exp) / Tdi-exp\] × 100, measured by B-mode ultrasound.

Time frame
Baseline (Day 1, at enrollment).
3

Diaphragmatic Excursion (DE) [cm]

Amplitude of diaphragmatic displacement measured by M-mode ultrasound during quiet breathing.

Time frame
Baseline (Day 1, at enrollment).
4

Group Differences in Diaphragmatic Thickness Across Cirrhosis Stages

Mean differences in diaphragmatic thickness (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata. Unit of Measure: Mean difference (cm).

Time frame
Baseline (Day 1, at enrollment)

Secondary outcomes

1

Correlation between diaphragmatic ultrasound parameters and skeletal muscle index (CT scans)

In patients with hepatocellular carcinoma, triphasic CT scans will be analyzed to calculate skeletal muscle index. These values will be correlated with diaphragmatic ultrasound parameters to assess the utility of ultrasound as a surrogate marker of sarcopenia.

Time frame
At baseline (single measurement)
2

Change in Diaphragmatic Thickness After Paracentesis

Change in diaphragmatic thickness (cm) measured by B-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis. Unit of Measure: Mean difference (cm).

Time frame
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
3

Change in Diaphragmatic Thickening Fraction After Paracentesis

Change in diaphragmatic thickening fraction (%) measured by B-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis. Unit of Measure: Mean difference (%).

Time frame
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
4

Change in Diaphragmatic Excursion After Paracentesis

Change in diaphragmatic excursion (cm) measured by M-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis. Unit of Measure: Mean difference (cm).

Time frame
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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