Cirrhosis
Conditions
Keywords
Paracentesis, Ascites
Brief summary
The purpose of this study is to compare two different methods that are used for inserting the needle during paracentesis. One method is called the coaxial insertion technique and the other is called the z-tract technique. Researchers would like to see which method is better and leads to less problems like oozing from the needle insertion site and pain during the procedure. Both methods are approved and currently used methods for doing a paracentesis at the University of Virginia. Which method is used generally depends on physician preference. There have been no studies done to date that compare these two methods for needle insertion.
Interventions
PROCEDUREZ-tract Insertion Technique
PROCEDURECoaxial Insertion Technique
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Agreement to participate * Patients with cirrhosis (confirmed by liver biopsy or clinically diagnosed) and ascites * Patients presenting to UVA Digestive Health Clinic for a scheduled therapeutic paracentesis who do not have any contraindications to the procedure * Ability to be reliably contacted by phone 24 hours following paracentesis
Exclusion criteria
* Prisoners * Non-english speaking * Paracentesis with less than 5 liters of ascitic fluid removed. (If this occurs, the specific subject encounter will be removed from the study but the subject may be included if at their next regularly scheduled paracentesis 5 liters or greater of ascitic fluid is removed.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post procedural leaking at the needle insertion site | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported procedural pain | Immediately following paracentesis |
Countries
United States
Outcome results
None listed