An observational study in Cirrhosis of the Liver, Ascites and Pleural Effusion Disorder, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Assiut University · Observational
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
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.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 54 observational studies indexed under Ascites.
Browse Ascites studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Ascites, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
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).
Diaphragmatic Excursion (DE) [cm]
Amplitude of diaphragmatic displacement measured by M-mode ultrasound during quiet breathing.
Time frame: Baseline (Day 1, at enrollment).
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)
Group Differences in Diaphragmatic Thickening Fraction Across Cirrhosis Stages
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 (%).
Time frame: Baseline (Day 1, at enrollment).
Group Differences in Diaphragmatic Excursion Across Cirrhosis Stages
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).
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickness with Disease Severity
Correlation between diaphragmatic thickness (cm) and liver disease severity scores (Child-Pugh class, MELD score). Unit of Measure: Correlation coefficient (r).
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickening Fraction (TF) with Disease Severity
Correlation between diaphragmatic thickening fraction (%) and liver disease severity scores (Child-Pugh class, MELD score). Unit of Measure: Correlation coefficient (r).
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Excursion (DE) with Disease Severity
Correlation between diaphragmatic excursion (cm) and liver disease severity scores (Child-Pugh class, MELD score). Unit of Measure: Correlation coefficient (r).
Time frame: Baseline (Day 1, at enrollment).
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)
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.
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.
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.
Diaphragmatic Thickness in Patients With vs. Without Hepatic Hydrothorax
Comparison of mean diaphragmatic thickness (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax. Unit of Measure: Mean difference (cm).
Time frame: Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction in Patients With vs. Without Hepatic Hydrothorax
Comparison of mean diaphragmatic thickening fraction (%) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax. Unit of Measure: Mean difference (%).
Time frame: Baseline (Day 1, at enrollment).
Diaphragmatic Excursion in Patients With vs. Without Hepatic Hydrothorax
Comparison of mean diaphragmatic excursion (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax. Unit of Measure: Mean difference (cm).
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Dyspnea Score
Correlation between diaphragmatic dysfunction (defined by ultrasound parameters) and dyspnea severity measured by the mMRC scale (0-4). Unit of Measure: Correlation coefficient (r).
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Respiratory Rate
Correlation between diaphragmatic dysfunction and respiratory rate (breaths/min). Unit of Measure: Correlation coefficient (r).
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Oxygen Saturation
Correlation between diaphragmatic dysfunction and peripheral oxygen saturation (SpO₂, %). Unit of Measure: Correlation coefficient (r).
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Length of Hospital Stay
Correlation between diaphragmatic dysfunction (defined by ultrasound parameters: thickness, thickening fraction, excursion) and length of hospital stay (days). Unit of Measure: Correlation coefficient (r).
Time frame: During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with ICU Admission
Correlation between diaphragmatic dysfunction and need for ICU admission. Unit of Measure: Odds ratio (% of patients requiring ICU admission).
Time frame: During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with In-Hospital Complications
Correlation between diaphragmatic dysfunction and occurrence of complications (e.g., respiratory failure, infection). Unit of Measure: Incidence (% of patients with complications).
Time frame: During hospitalization (up to 30 days).
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 28 observational studies under Ascites, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 20. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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