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OpenTrials
Completed

NCT Number: NCT02310165

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.

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Key information

Conditions

Cirrhosis Ascites Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Z-tract Insertion Technique

Procedure

Coaxial Insertion Technique

Procedure

Primary outcomes

  1. Post procedural leaking at the needle insertion site

    Time frame: 24 hours

Secondary outcomes

  1. Patient reported procedural pain

    Time frame: Immediately following paracentesis

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Z-tract Versus Coaxial Insertion Technique in Large Volume Paracentesis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2014
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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