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 CirrhosisThis 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
- Nada Refaat Mohamed, MD+201019860918
- Mohamed Abdelghany Abdelhamed+201112828724
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