Insertion Technique in Large Volume Paracentesis

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Procedure: Z-tract Insertion Technique; Procedure: Coaxial Insertion Technique

• Registration Number: NCT02310165
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-03
• Last Update Submitted: 2014-12-03
• Study First Posted: 2014-12-05
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Z-tract Insertion Technique	Z-tract Insertion Technique	For this technique, the skin is pulled 2 cm downward before the paracentesis needle is inserted and advanced.
Coaxial Insertion Technique	Coaxial Insertion Technique	For this technique, the needle is directly inserted to minimize the distance between he cutaneous tissue and ascites

Primary Outcome Measures

Name	Time	Method
Post procedural leaking at the needle insertion site	24 hours

Secondary Outcome Measures

Name	Time	Method
Patient reported procedural pain	Immediately following paracentesis

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States