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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Ascites Hepatic

Intervention / Treatment
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* Device: KARAHOC device
* Device: Angiocatheter


Participation Criteria
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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:(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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: multi-center, prospective, interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KARAHOC group<br>A group of patients in which paracentesis will be performed using a KARAHOC device. | Device: KARAHOC device<br>* 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.<br>|
| Active Comparator: conventional group<br>A group of patients in which paracentesis will be performed using an angiocatheter. | Device: Angiocatheter<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis | 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 | the frequency of bleeding, hypotension, acute kidney injury, infection | through study completion, an average of 1 year | 
| operator satisfaction for each procedure | 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 | 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 | Whether to do paracentesis again due to initial failure or catheter dislocation | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paracentesis, cirrhosis, ascites