Comparison Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis
Study Details
Study Description
Brief Summary
Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis [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.
Secondary Outcome Measures
- comparison of complication rate [through study completion, an average of 1 year]
the frequency of bleeding, hypotension, acute kidney injury, infection
- operator satisfaction for each procedure [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
- patient satisfaction for each procedure [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
- Number of Participants with repeated paracentesis [through study completion, an average of 1 year]
Whether to do paracentesis again due to initial failure or catheter dislocation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult over the age of 19
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Patients with pathological or clinical diagnosis of liver cirrhosis
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Patients with Grade 2 or higher grade of ascites as a complication due to portal hypertension
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Patients requiring periodic paracentesis
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Patients consent to this study
Exclusion Criteria:(If at least one of the following conditions apply)
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Patients with ascites due to peritoneal metastasis due to malignant tumor
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Patients with high bleeding risk (PT INR>3, PLT<30,000/mm3) difficult to perform ascites puncture
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Patients with hepatic encephalopathy or hepatorenal syndrome(HRS)
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Patients with severe cardiovascular disease, lung disease, or DIC
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Patients refusing paracentesis
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Patients who can control ascites using diuretics
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Soon Chun Hyang University Bucheon Hospital | Bucheon | Gyeonggi Do | Korea, Republic of | 14584 |
Sponsors and Collaborators
- Sang Gyune Kim
Investigators
- Principal Investigator: Sang gyune Kim, PhD, Soonchunhyang University Hospital
Study Documents (Full-Text)
More Information
Publications
- Gentilini P, Casini-Raggi V, Di Fiore G, Romanelli RG, Buzzelli G, Pinzani M, La Villa G, Laffi G. Albumin improves the response to diuretics in patients with cirrhosis and ascites: results of a randomized, controlled trial. J Hepatol. 1999 Apr;30(4):639-45. doi: 10.1016/s0168-8278(99)80194-9.
- Gines P, Arroyo V, Quintero E, Planas R, Bory F, Cabrera J, Rimola A, Viver J, Camps J, Jimenez W, et al. Comparison of paracentesis and diuretics in the treatment of cirrhotics with tense ascites. Results of a randomized study. Gastroenterology. 1987 Aug;93(2):234-41. doi: 10.1016/0016-5085(87)91007-9.
- Iwakiri Y. Pathophysiology of portal hypertension. Clin Liver Dis. 2014 May;18(2):281-91. doi: 10.1016/j.cld.2013.12.001. Epub 2014 Feb 25.
- Moore KP, Aithal GP. Guidelines on the management of ascites in cirrhosis. Gut. 2006 Oct;55 Suppl 6(Suppl 6):vi1-12. doi: 10.1136/gut.2006.099580. No abstract available.
- Quintero E, Gines P, Arroyo V, Rimola A, Bory F, Planas R, Viver J, Cabrera J, Rodes J. Paracentesis versus diuretics in the treatment of cirrhotics with tense ascites. Lancet. 1985 Mar 16;1(8429):611-2. doi: 10.1016/s0140-6736(85)92147-6.
- Salerno F, Badalamenti S, Incerti P, Tempini S, Restelli B, Bruno S, Bellati G, Roffi L. Repeated paracentesis and i.v. albumin infusion to treat 'tense' ascites in cirrhotic patients. A safe alternative therapy. J Hepatol. 1987 Aug;5(1):102-8. doi: 10.1016/s0168-8278(87)80067-3.
- KARAHOC STUDY