Insertion Technique in Large Volume Paracentesis

NCT02310165 | Completed DMC

• 1 other identifier: 16842
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Keywords

Paracentesis; Ascites

Outcome Measures

Primary Outcomes (1)

• Post procedural leaking at the needle insertion site

  24 hours

Secondary Outcomes (1)

• Patient reported procedural pain

  Immediately following paracentesis

Study Arms (2)

Z-tract Insertion Technique

OTHER

For this technique, the skin is pulled 2 cm downward before the paracentesis needle is inserted and advanced.

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

Procedure: Coaxial Insertion Technique

Interventions

Z-tract Insertion Technique PROCEDURE

Z-tract Insertion Technique

Coaxial Insertion Technique PROCEDURE

Coaxial Insertion Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Fibrosis; Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy Rubin, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gastroenterology

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (1)