CirrhosisNCT02310165
Insertion Technique in Large Volume Paracentesis
A study testing Z-tract Insertion Technique and Coaxial Insertion Technique in people with Cirrhosis, run by University of Virginia at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Z-tract Insertion Technique and Coaxial Insertion Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: 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.
- Conditions
- Cirrhosis
- Being tested
- Z-tract Insertion Technique, Coaxial Insertion Technique
- Keywords
- Paracentesis, Ascites
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-tract Insertion TechniqueProcedure or surgery
Coaxial Insertion TechniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Z-tract Insertion Technique | Other | For this technique, the skin is pulled 2 cm downward before the paracentesis needle is inserted and advanced. Receives: Procedure: Z-tract Insertion Technique |
| Coaxial Insertion Technique | Other | For this technique, the needle is directly inserted to minimize the distance between he cutaneous tissue and ascites Receives: Procedure: Coaxial Insertion Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post procedural leaking at the needle insertion site
Measured: 24 hours
Secondary outcomes (1)
Patient reported procedural pain
Measured: Immediately following paracentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Rubin, MD, University of Virginia
- Investigators
- Amy Rubin, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310165
- Sponsor's protocol ID
- 16842
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z-tract Versus Coaxial Insertion Technique in Large Volume Paracentesis
- ClinicalTrials.gov ID
- NCT02310165
- Acronym / sponsor ID
- 16842
- Conditions
- Cirrhosis
- Keywords
- Paracentesis, Ascites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-tract Insertion Technique | Other | Procedure: Z-tract Insertion TechniqueFor this technique, the skin is pulled 2 cm downward before the paracentesis needle is inserted and advanced. |
| Coaxial Insertion Technique | Other | Procedure: Coaxial Insertion TechniqueFor this technique, the needle is directly inserted to minimize the distance between he cutaneous tissue and ascites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z-tract Insertion Technique | Procedure or surgery | Z-tract Insertion Technique |
| Coaxial Insertion Technique | Procedure or surgery | Coaxial Insertion Technique |
Primary outcome
Post procedural leaking at the needle insertion site
Time frame: 24 hours
1 secondary outcome
Patient reported procedural pain
Time frame: Immediately following paracentesis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Rubin, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-tract Insertion Technique and Coaxial Insertion Technique in people with Cirrhosis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post procedural leaking at the needle insertion site (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.