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

NCT05578573 | Unknown

• 1 other identifier: KARAHOC STUDY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ascites Hepatic

Keywords

paracentesis; cirrhosis; ascites

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• comparison of complication rate

  through study completion, an average of 1 year

• operator satisfaction for each procedure

  through study completion, an average of 1 year

• patient satisfaction for each procedure

  through study completion, an average of 1 year

• Number of Participants with repeated paracentesis

  through study completion, an average of 1 year

Study Arms (2)

KARAHOC group

EXPERIMENTAL

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

Device: KARAHOC device

conventional group

ACTIVE COMPARATOR

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

Device: Angiocatheter

Interventions

KARAHOC device 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.

KARAHOC group

Angiocatheter 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

conventional group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sang Gyune Kim: lead

Study Sites (1)

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Related Publications (6)

• 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.

  PMID: 24679494 BACKGROUND

• 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.

  PMID: 16966752 BACKGROUND

• 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.

  PMID: 10207805 BACKGROUND

• 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.

  PMID: 3297907 BACKGROUND

• 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.

  PMID: 2857949 BACKGROUND

• 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.

  PMID: 3655306 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang gyune Kim, PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: multi-center, prospective, interventional study

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: October 13, 2022
• Study Start: January 17, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)