Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
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
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
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.
Time frame: through study completion, an average of 1 year
comparison of complication rate
the frequency of bleeding, hypotension, acute kidney injury, infection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
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