Assessing quality of life and muscle loss in patients with fluid buildup in the abdomen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the quality of life in patients suffering from refractory ascites, a condition characterized by fluid accumulation in the abdomen. It will utilize newer quality of life survey instruments to gather data on both benign and malignant causes of ascites. Additionally, the study will assess sarcopenia, or muscle loss, in these patients by measuring muscle area through CT imaging at specific intervals. Data will be collected at baseline and then at 1, 2, 4, and 6 months to track changes over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>/=18
2. Eastern Cooperative Oncology Group (ECOG) performance score \< 3
3. Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.
4. Capable of giving informed consent

Exclusion Criteria:

1. Life expectancy less than 3 months
2. Unable to participate in neuropsychological tests/questionnaires
3. Pregnant or nursing women. .

Where it's running

• University of Pennsylvania Perelman School of Medicine
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Michael Soulen, MD — University of Pennsylvania
• Study coordinator: Michael C Soulen, MD
• Email: michael.soulen@pennmedicine.upenn.edu
• Phone: 2154218647

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using TIPS Stent Graft to treat complications of cirrhosis and portal hypertension

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.