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

Sponsor
Assiut University
Study ID
NCT07667608
Status
Not Yet Recruiting

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Conditions

  • Ascites
  • Cirrhosis of the Liver
  • Diaphragm Movement
  • Hepatocellular Carcinoma (HCC)
  • Pleural Effusion Disorder
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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

Key Dates

First listed
Jun 25, 2026
Start date
Aug 10, 2026
Status verified
Jun 2026
Primary completion
Aug 10, 2027
Completion
Dec 10, 2027

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm] [ Time Frame: Baseline (Day 1, at enrollment). ]

Central Contacts

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