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

Primary Purpose

Ascites Hepatic

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

KARAHOC device

Angiocatheter

About this trial

This is an interventional treatment trial for Ascites Hepatic focused on measuring paracentesis, cirrhosis, ascites

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Soon Chun Hyang University Bucheon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KARAHOC group

conventional group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

comparison of complication rate

the frequency of bleeding, hypotension, acute kidney injury, infection

operator satisfaction for each procedure

measure the amount of satisfaction using visual analogue scales distributed from 1 to 10, higher score means better outcome

patient satisfaction for each procedure

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

Whether to do paracentesis again due to initial failure or catheter dislocation

Full Information

NCT ID

NCT05578573

First Posted

January 16, 2022

Last Updated

October 10, 2022

Sponsor

Sang Gyune Kim

1. Study Identification

Unique Protocol Identification Number

NCT05578573

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

January 17, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sang Gyune Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ascites Hepatic

Keywords

paracentesis, cirrhosis, ascites

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

multi-center, prospective, interventional study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KARAHOC group

Arm Type

Experimental

Arm Description

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

Arm Title

conventional group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

KARAHOC device

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Angiocatheter

Intervention Description

Primary Outcome Measure Information:

Title

Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis

Description

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

Secondary Outcome Measure Information:

Title

comparison of complication rate

Description

the frequency of bleeding, hypotension, acute kidney injury, infection

Time Frame

through study completion, an average of 1 year

Title

operator satisfaction for each procedure

Description

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

Title

patient satisfaction for each procedure

Description

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

Title

Number of Participants with repeated paracentesis

Description

Whether to do paracentesis again due to initial failure or catheter dislocation

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang gyune Kim, PhD

Organizational Affiliation

Soonchunhyang University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soon Chun Hyang University Bucheon Hospital

City

Bucheon

State/Province

Gyeonggi Do

ZIP/Postal Code

14584

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make IPD available.

Citations:

PubMed Identifier

24679494

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.

Results Reference

background

PubMed Identifier

16966752

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.

Results Reference

background

PubMed Identifier

10207805

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.

Results Reference

background

PubMed Identifier

3297907

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.

Results Reference

background

PubMed Identifier

2857949

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.

Results Reference

background

PubMed Identifier

3655306

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.

Results Reference

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

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