Insertion Technique in Large Volume Paracentesis

Z-tract Versus Coaxial Insertion Technique in Large Volume Paracentesis

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Procedure: Z-tract Insertion Technique; Procedure: Coaxial Insertion Technique

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient reported procedural pain	Immediately following paracentesis

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Amy Rubin, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Ascites; Paracentesis
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: 16842