Clinical trial NCT05578573: Comparison Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis
Official title: Comparison of Success Rate and Complication Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis in Cirrhotic Patients With Ascites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ascites Hepatic
Keywords: paracentesis
cirrhosis
ascites
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: multi-center, prospective, interventional study
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: comparison of complication rate
timeFrame: through study completion, an average of 1 year
measure: operator satisfaction for each procedure
timeFrame: through study completion, an average of 1 year
measure: patient satisfaction for each procedure
timeFrame: through study completion, an average of 1 year
measure: Number of Participants with repeated paracentesis
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
state: Gyeonggi Do
Study officials:
affiliation: Soonchunhyang University Hospital
name: Sang gyune Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.