Insertion Technique in Large Volume Paracentesis

Study Overview
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Brief Summary
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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.

Official Title
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Z-tract Versus Coaxial Insertion Technique in Large Volume Paracentesis

Conditions
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Cirrhosis

Intervention / Treatment
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* Procedure: Z-tract Insertion Technique
* Procedure: Coaxial Insertion Technique


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Z-tract Insertion Technique<br>For this technique, the skin is pulled 2 cm downward before the paracentesis needle is inserted and advanced. | Procedure: Z-tract Insertion Technique<br> <br> |
| Other: Coaxial Insertion Technique<br>For this technique, the needle is directly inserted to minimize the distance between he cutaneous tissue and ascites | Procedure: Coaxial Insertion Technique<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post procedural leaking at the needle insertion site |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported procedural pain |  | Immediately following paracentesis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracentesis, Ascites