[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643884":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":18,"locations":10,"responsibleParty":28,"collaborators":10,"id":31,"slug":10,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":34,"acronym":10,"eligibilityCriteria":35,"healthyVolunteers":36,"sex":37,"minAge":38,"maxAge":10,"enrollmentInfo":39,"targetDuration":10,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":10},{"fullName":5,"class":6},"Assiut University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Adults with Liver Cirrhosis",null,"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.",[13,16],{"name":14,"affiliation":5,"role":15},"Ahmed Helmy Salem, professor","PRINCIPAL_INVESTIGATOR",{"name":17,"affiliation":5,"role":15},"Maiada Kamal Eldeen Hashem",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Nada Refaat Mohamed, MD","CONTACT","+201019860918","nadarefaat411@gmail.com",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Mohamed Abdelghany Abdelhamed","+201112828724","Moh7111@aun.edu.eg",{"type":15,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Nada Refaat Mohamed Abdelshafy Samasiri","Resident Physician, Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University","100643884",false,"NCT07667608","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","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.\n3. Ability to provide written informed consent in Arabic or English.\n4. For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.\n5. For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.\n6. For Subgroup C: radiologically confirmed HCC by triphasic CT or MRI according to EASL\u002FAASLD diagnostic criteria, with available CT imaging for L3 SMI analysis.\n\nExclusion Criteria:\n\n1. Significant pre-existing primary pulmonary disease (e.g., moderate-to-severe COPD defined as FEV1\u002FFVC \\\u003C70% with FEV1 \\\u003C60% predicted, interstitial lung disease, pulmonary fibrosis) that independently affects diaphragmatic mechanics.\n2. Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.\n3. Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.\n4. Active mechanical ventilation at time of enrollment.\n5. Pregnancy.\n6. Inability to achieve adequate ultrasound acoustic windows (e.g., due to extreme obesity or surgical dressings).\n7. Contraindications to paracentesis in Subgroup A (e.g., disseminated intravascular coagulation, bowel obstruction).\n8. Prior or planned liver transplantation within the study period, which would confound longitudinal follow-up.\n9. Refusal or inability to provide informed consent.",true,"ALL","18 Years",{"count":40,"type":41},120,"ESTIMATED","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:\n\nDo patients with cirrhosis show reduced diaphragmatic function compared to healthy adults?\n\nDoes removal of ascitic fluid by paracentesis improve diaphragmatic mechanics?\n\nCan ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans?\n\nParticipants will:\n\nUndergo diaphragmatic ultrasound during quiet and deep breathing\n\nProvide clinical and laboratory data related to liver disease severity\n\nIn some cases, have ultrasound repeated before and after paracentesis\n\nFor patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass",[45,46,47,48,49,50],"Cirrhosis of the Liver","Ascites","Pleural Effusion Disorder","Hepatocellular Carcinoma (HCC)","Sarcopenia","Diaphragm Movement","NOT_YET_RECRUITING","2026-06-19",{"date":54,"type":55},"2026-06-25","ACTUAL",{"date":57,"type":41},"2026-08-10",{"date":59,"type":41},"2027-12-10",{"name":5,"class":6}]