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NCT Number: NCT07667608

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

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

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Key information

Conditions

Cirrhosis of the Liver Adenocarcinoma Ascites Atrophy Carcinoma Carcinoma, Hepatocellular Diaphragm Movement Digestive System Diseases Digestive System Neoplasms Fibrosis Hepatocellular Carcinoma (HCC) Liver Diseases Liver Neoplasms Muscular Atrophy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pleural Diseases Pleural Effusion Pleural Effusion Disorder Respiratory Tract Diseases Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study is a prospective observational cohort designed to evaluate diaphragmatic structure and function in adults with liver cirrhosis. Using bedside ultrasound, the study will measure diaphragmatic thickness, thickening fraction, and excursion, and compare these values across different stages of liver disease severity and complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup of patients undergoing large-volume paracentesis will have ultrasound assessments before and after fluid removal to determine the acute impact of ascites drainage on diaphragmatic mechanics. In patients with hepatocellular carcinoma, existing CT scans will be analyzed to calculate skeletal muscle index, allowing correlation between ultrasound parameters and sarcopenia. Healthy volunteers will serve as a reference group for establishing normative values. Clinical and laboratory data, respiratory outcomes, and hospitalization details will also be collected to explore associations between diaphragmatic dysfunction and patient prognosis. The study aims to validate diaphragmatic ultrasound as a simple, non-invasive tool for respiratory monitoring and sarcopenia assessment in cirrhosis, particularly in resource-limited settings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.
  • For Subgroup C: radiologically confirmed HCC by triphasic CT or MRI according to EASL/AASLD diagnostic criteria, with available CT imaging for L3 SMI analysis.

Exclusion criteria

  • 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.
  • Pregnancy.
  • Inability to achieve adequate ultrasound acoustic windows (e.g., due to extreme obesity or surgical dressings).
  • Contraindications to paracentesis in Subgroup A (e.g., disseminated intravascular coagulation, bowel obstruction).
  • Prior or planned liver transplantation within the study period, which would confound longitudinal follow-up.
  • Refusal or inability to provide informed consent.

Treatment and study plan

Primary outcomes

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

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

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

  2. Diaphragmatic Thickening Fraction (TF) [%]

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

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

  3. Diaphragmatic Excursion (DE) [cm]

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

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

  4. Group Differences in Diaphragmatic Thickness Across Cirrhosis Stages

    Time frame: Baseline (Day 1, at enrollment)

    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).

  5. Group Differences in Diaphragmatic Thickening Fraction Across Cirrhosis Stages

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

    Mean differences in diaphragmatic thickening fraction (%) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.

    Unit of Measure: Mean difference (%).

  6. Group Differences in Diaphragmatic Excursion Across Cirrhosis Stages

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

    Mean differences in diaphragmatic excursion (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.

    Unit of Measure: Mean difference (cm).

  7. Correlation of Diaphragmatic Thickness with Disease Severity

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

    Correlation between diaphragmatic thickness (cm) and liver disease severity scores (Child-Pugh class, MELD score).

    Unit of Measure: Correlation coefficient (r).

  8. Correlation of Diaphragmatic Thickening Fraction (TF) with Disease Severity

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

    Correlation between diaphragmatic thickening fraction (%) and liver disease severity scores (Child-Pugh class, MELD score).

    Unit of Measure: Correlation coefficient (r).

  9. Correlation of Diaphragmatic Excursion (DE) with Disease Severity

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

    Correlation between diaphragmatic excursion (cm) and liver disease severity scores (Child-Pugh class, MELD score).

    Unit of Measure: Correlation coefficient (r).

Secondary outcomes

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

    Time frame: At baseline (single measurement)

    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.

  2. Change in Diaphragmatic Thickness After Paracentesis

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

  3. Change in Diaphragmatic Thickening Fraction After Paracentesis

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

  4. Change in Diaphragmatic Excursion After Paracentesis

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

  5. Diaphragmatic Thickness in Patients With vs. Without Hepatic Hydrothorax

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

    Comparison of mean diaphragmatic thickness (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.

    Unit of Measure: Mean difference (cm).

  6. Diaphragmatic Thickening Fraction in Patients With vs. Without Hepatic Hydrothorax

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

    Comparison of mean diaphragmatic thickening fraction (%) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.

    Unit of Measure: Mean difference (%).

  7. Diaphragmatic Excursion in Patients With vs. Without Hepatic Hydrothorax

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

    Comparison of mean diaphragmatic excursion (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.

    Unit of Measure: Mean difference (cm).

  8. Correlation of Diaphragmatic Dysfunction with Dyspnea Score

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

    Correlation between diaphragmatic dysfunction (defined by ultrasound parameters) and dyspnea severity measured by the mMRC scale (0-4).

    Unit of Measure: Correlation coefficient (r).

  9. Correlation of Diaphragmatic Dysfunction with Respiratory Rate

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

    Correlation between diaphragmatic dysfunction and respiratory rate (breaths/min).

    Unit of Measure: Correlation coefficient (r).

  10. Correlation of Diaphragmatic Dysfunction with Oxygen Saturation

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

    Correlation between diaphragmatic dysfunction and peripheral oxygen saturation (SpO₂, %).

    Unit of Measure: Correlation coefficient (r).

  11. Correlation of Diaphragmatic Dysfunction with Length of Hospital Stay

    Time frame: During hospitalization (up to 30 days).

    Correlation between diaphragmatic dysfunction (defined by ultrasound parameters: thickness, thickening fraction, excursion) and length of hospital stay (days). Unit of Measure: Correlation coefficient (r).

  12. Correlation of Diaphragmatic Dysfunction with ICU Admission

    Time frame: During hospitalization (up to 30 days).

    Correlation between diaphragmatic dysfunction and need for ICU admission. Unit of Measure: Odds ratio (% of patients requiring ICU admission).

  13. Correlation of Diaphragmatic Dysfunction with In-Hospital Complications

    Time frame: During hospitalization (up to 30 days).

    Correlation between diaphragmatic dysfunction and occurrence of complications (e.g., respiratory failure, infection). Unit of Measure: Incidence (% of patients with complications).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Abdelghany Abdelhamed

CONTACT

[email protected]

+201112828724

Nada Refaat Mohamed, MD

CONTACT

[email protected]

+201019860918

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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