MedDataX Logo

Insertion Technique in Large Volume Paracentesis

NCT ID: NCT02310165

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cirrhosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Paracentesis Ascites

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Z-tract Insertion Technique

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

Group Type OTHER

Z-tract Insertion Technique

Intervention Type PROCEDURE

Coaxial Insertion Technique

For this technique, the needle is directly inserted to minimize the distance between he cutaneous tissue and ascites

Group Type OTHER

Coaxial Insertion Technique

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Z-tract Insertion Technique

Intervention Type PROCEDURE

Coaxial Insertion Technique

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amy Rubin, MD

Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy Rubin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16842

Identifier Type: -

Identifier Source: org_study_id