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

Ascites Hepatic Clinical Trial

Official title:

Comparison of Success Rate and Complication Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis in Cirrhotic Patients With Ascites

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05578573
• Other study ID #: KARAHOC STUDY
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic

Intervention

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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon	Gyeonggi Do

Sponsors (1)

Lead Sponsor	Collaborator
Sang Gyune Kim

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View Citation

Ginés P, Arroyo V, Quintero E, Planas R, Bory F, Cabrera J, Rimola A, Viver J, Camps J, Jiménez 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. — View 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. Review. — View Citation

Moore KP, Aithal GP. Guidelines on the management of ascites in cirrhosis. Gut. 2006 Oct;55 Suppl 6:vi1-12. — View Citation

Quintero E, Ginés P, Arroyo V, Rimola A, Bory F, Planas R, Viver J, Cabrera J, Rodés J. Paracentesis versus diuretics in the treatment of cirrhotics with tense ascites. Lancet. 1985 Mar 16;1(8429):611-2. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	comparison of complication rate	the frequency of bleeding, hypotension, acute kidney injury, infection	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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