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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

19 juin 2026 mis à jour par: Nada Refaat Mohamed Abdelshafy Samasiri, Assiut University

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

120

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Mohamed Abdelghany Abdelhamed
  • Numéro de téléphone: +201112828724
  • E-mail: Moh7111@aun.edu.eg

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.
  3. Ability to provide written informed consent in Arabic or English.
  4. For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.
  5. For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.
  6. 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:

  1. 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.
  2. Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.
  3. Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.
  4. Active mechanical ventilation at time of enrollment.
  5. Pregnancy.
  6. Inability to achieve adequate ultrasound acoustic windows (e.g., due to extreme obesity or surgical dressings).
  7. Contraindications to paracentesis in Subgroup A (e.g., disseminated intravascular coagulation, bowel obstruction).
  8. Prior or planned liver transplantation within the study period, which would confound longitudinal follow-up.
  9. Refusal or inability to provide informed consent.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Adults with Liver Cirrhosis
This cohort includes adults diagnosed with liver cirrhosis, with subgroups defined by complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup undergoing paracentesis will be assessed before and after fluid removal to evaluate acute changes in diaphragmatic function. In patients with hepatocellular carcinoma, CT scans will be analyzed to calculate skeletal muscle index for correlation with ultrasound findings. A small number of healthy volunteers will also undergo diaphragmatic ultrasound to establish normative reference values; however, they are not considered a separate cohort for analysis.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm]
Délai: Baseline (Day 1, at enrollment).
Diaphragmatic thickness at end-expiration (Tdi-exp) and end-inspiration (Tdi-insp) measured by B-mode ultrasound.
Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction (TF) [%]
Délai: Baseline (Day 1, at enrollment).
Thickening fraction calculated as [(Tdi-insp - Tdi-exp) / Tdi-exp] × 100, measured by B-mode ultrasound.
Baseline (Day 1, at enrollment).
Diaphragmatic Excursion (DE) [cm]
Délai: Baseline (Day 1, at enrollment).
Amplitude of diaphragmatic displacement measured by M-mode ultrasound during quiet breathing.
Baseline (Day 1, at enrollment).
Group Differences in Diaphragmatic Thickness Across Cirrhosis Stages
Délai: 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).
Baseline (Day 1, at enrollment)
Group Differences in Diaphragmatic Thickening Fraction Across Cirrhosis Stages
Délai: 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 (%).
Baseline (Day 1, at enrollment).
Group Differences in Diaphragmatic Excursion Across Cirrhosis Stages
Délai: 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).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickness with Disease Severity
Délai: 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).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickening Fraction (TF) with Disease Severity
Délai: 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).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Excursion (DE) with Disease Severity
Délai: 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).
Baseline (Day 1, at enrollment).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation between diaphragmatic ultrasound parameters and skeletal muscle index (CT scans)
Délai: 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.
At baseline (single measurement)
Change in Diaphragmatic Thickness After Paracentesis
Délai: 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).
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Thickening Fraction After Paracentesis
Délai: 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 (%).
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Excursion After Paracentesis
Délai: 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).
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Diaphragmatic Thickness in Patients With vs. Without Hepatic Hydrothorax
Délai: 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).
Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction in Patients With vs. Without Hepatic Hydrothorax
Délai: 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 (%).
Baseline (Day 1, at enrollment).
Diaphragmatic Excursion in Patients With vs. Without Hepatic Hydrothorax
Délai: 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).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Dyspnea Score
Délai: 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).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Respiratory Rate
Délai: Baseline (Day 1, at enrollment).

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

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Oxygen Saturation
Délai: Baseline (Day 1, at enrollment).

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

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Length of Hospital Stay
Délai: 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).
During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with ICU Admission
Délai: 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).
During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with In-Hospital Complications
Délai: 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).
During hospitalization (up to 30 days).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Assiut University

Les enquêteurs

  • Chercheur principal: Ahmed Helmy Salem, professor, Assiut University
  • Chercheur principal: Maiada Kamal Eldeen Hashem, Assiut University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 août 2026

Achèvement primaire (Estimé)

10 août 2027

Achèvement de l'étude (Estimé)

10 décembre 2027

Dates d'inscription aux études

Première soumission

16 juin 2026

Première soumission répondant aux critères de contrôle qualité

19 juin 2026

Première publication (Réel)

25 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DiaphragmCirrhosis_AU26

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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