Comparison Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis

October 10, 2022 updated by: Sang Gyune Kim

Comparison of Success Rate and Complication Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis in Cirrhotic Patients With Ascites

Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center, prospective, interventional study, in which subjects who meet the selection criteria are registered at each institution during the study period from the date of research approval. Regardless of the order, paracentesis using KARAHOC and conventional angiocatheter will be performed once in all patients. The criteria for successful paracentesis is set as 3L or more of ascites drainage. During paracentesis, albumin will be infused in all patients. Heart rate and blood pressure will be measured before the procedure and right after the completion of drainage, and 30 minutes later. The incidence of complications will be compared between two methods. In addition, patient and operator satisfaction will be investigated using a visual analogue scale.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi Do
      • Bucheon, Gyeonggi Do, Korea, Republic of, 14584
        • Soon Chun Hyang University Bucheon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult over the age of 19
  • Patients with pathological or clinical diagnosis of liver cirrhosis
  • Patients with Grade 2 or higher grade of ascites as a complication due to portal hypertension
  • Patients requiring periodic paracentesis
  • Patients consent to this study

Exclusion Criteria:(If at least one of the following conditions apply)

  • Patients with ascites due to peritoneal metastasis due to malignant tumor
  • Patients with high bleeding risk (PT INR>3, PLT<30,000/mm3) difficult to perform ascites puncture
  • Patients with hepatic encephalopathy or hepatorenal syndrome(HRS)
  • Patients with severe cardiovascular disease, lung disease, or DIC
  • Patients refusing paracentesis
  • Patients who can control ascites using diuretics
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KARAHOC group
A group of patients in which paracentesis will be performed using a KARAHOC device.
Device: KARAHOC device
After leaving a mark on the part where the puncture is to be performed using a pen, sterilization dressing are performed, local anesthesia is performed aseptic then ascites paracentesis by KARAHOC device.
Active Comparator: conventional group
A group of patients in which paracentesis will be performed using an angiocatheter.
Device: Angiocatheter
After leaving a mark on the part where the puncture is to be performed using a pen, sterilization dressing are performed, local anesthesia is performed aseptic then ascites paracentesis by angiocatheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis
Time Frame: through study completion, an average of 1 year
The criterion for successful paracentesis is defined as drainage of 3L or more at an initial attempt.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of complication rate
Time Frame: through study completion, an average of 1 year
the frequency of bleeding, hypotension, acute kidney injury, infection
through study completion, an average of 1 year
operator satisfaction for each procedure
Time Frame: through study completion, an average of 1 year
measure the amount of satisfaction using visual analogue scales distributed from 1 to 10, higher score means better outcome
through study completion, an average of 1 year
patient satisfaction for each procedure
Time Frame: through study completion, an average of 1 year
measure the amount of satisfaction using visual analogue scales distributed from 1 to 10, higher score means better outcome
through study completion, an average of 1 year
Number of Participants with repeated paracentesis
Time Frame: through study completion, an average of 1 year
Whether to do paracentesis again due to initial failure or catheter dislocation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sang Gyune Kim

Investigators

  • Principal Investigator: Sang gyune Kim, PhD, Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KARAHOC STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ascites Hepatic

Clinical Trials on KARAHOC device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe