Back to resultsInsertion Technique in Large Volume Paracentesis
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Z-tract Insertion Technique
Coaxial Insertion Technique
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis focused on measuring Paracentesis, Ascites
Eligibility Criteria
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.)
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Z-tract Insertion Technique
Coaxial Insertion Technique
Arm Description
For this technique, the skin is pulled 2 cm downward before the paracentesis needle is inserted and advanced.
For this technique, the needle is directly inserted to minimize the distance between he cutaneous tissue and ascites
Outcomes
Primary Outcome Measures
Post procedural leaking at the needle insertion site
Secondary Outcome Measures
Patient reported procedural pain
Full Information
NCT ID
NCT02310165
First Posted
December 3, 2014
Last Updated
December 3, 2014
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT02310165
Brief Title
Insertion Technique in Large Volume Paracentesis
Official Title
Z-tract Versus Coaxial Insertion Technique in Large Volume Paracentesis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
Paracentesis, Ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Z-tract Insertion Technique
Arm Type
Other
Arm Description
For this technique, the skin is pulled 2 cm downward before the paracentesis needle is inserted and advanced.
Arm Title
Coaxial Insertion Technique
Arm Type
Other
Arm Description
For this technique, the needle is directly inserted to minimize the distance between he cutaneous tissue and ascites
Intervention Type
Procedure
Intervention Name(s)
Z-tract Insertion Technique
Intervention Type
Procedure
Intervention Name(s)
Coaxial Insertion Technique
Primary Outcome Measure Information:
Title
Post procedural leaking at the needle insertion site
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Patient reported procedural pain
Time Frame
Immediately following paracentesis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Rubin, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
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Insertion Technique in Large Volume Paracentesis
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