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

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ascites Hepatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

multi-center, prospective, interventional study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KARAHOC group

A group of patients in which paracentesis will be performed using a KARAHOC device.

Group Type EXPERIMENTAL

KARAHOC device

Intervention Type 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.

conventional group

A group of patients in which paracentesis will be performed using an angiocatheter.

Group Type ACTIVE_COMPARATOR

Angiocatheter

Intervention Type 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 angiocatheter

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No