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

Sang Gyune Kim

Status: Invitation-only

Conditions: Ascites Hepatic

Treatments: Device: Angiocatheter; Device: KARAHOC device

Study type: Interventional

Funder types: Other

Identifiers

NCT05578573

KARAHOC STUDY

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

KARAHOC group

Experimental group

Description:

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

Treatment:

Device: KARAHOC device

conventional group

Active Comparator group

Description:

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

Treatment:

Device: Angiocatheter