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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 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

120

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Nada Refaat Mohamed, MD
Numero di telefono: +201019860918
Email: nadarefaat411@gmail.com

Backup dei contatti dello studio

Nome: Mohamed Abdelghany Abdelhamed
Numero di telefono: +201112828724
Email: Moh7111@aun.edu.eg

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
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.

Gruppo / Coorte

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm] Lasso di tempo: 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) [%] Lasso di tempo: 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] Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Correlation between diaphragmatic ultrasound parameters and skeletal muscle index (CT scans) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assiut University

Investigatori

Investigatore principale: Ahmed Helmy Salem, professor, Assiut University
Investigatore principale: Maiada Kamal Eldeen Hashem, Assiut University

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 agosto 2026

Completamento primario (Stimato)

10 agosto 2027

Completamento dello studio (Stimato)

10 dicembre 2027

Date di iscrizione allo studio

Primo inviato

16 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 giugno 2026

Primo Inserito (Effettivo)

25 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)