Ascites HepaticNCT05578573
Comparison Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis
A study testing KARAHOC device and Angiocatheter in people with Ascites Hepatic, run by Sang Gyune Kim at 1 site in South Korea.
Trial summary
Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ascites Hepatic
- What is being tested?
- KARAHOC device and Angiocatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
About this study
Official title: Comparison of Success Rate and Complication Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis in Cirrhotic Patients With Ascites
Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.
Read the 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.
- Conditions
- Ascites Hepatic
- Being tested
- KARAHOC device, Angiocatheter
- Keywords
- paracentesis, cirrhosis, ascites
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KARAHOC deviceDevice
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.
AngiocatheterDevice
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
| Study group | Role | What they receive |
|---|---|---|
| KARAHOC group | Experimental | A group of patients in which paracentesis will be performed using a KARAHOC device. Receives: Device: KARAHOC device |
| conventional group | Active comparator | A group of patients in which paracentesis will be performed using an angiocatheter. Receives: Device: Angiocatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
comparison of complication rate
the frequency of bleeding, hypotension, acute kidney injury, infection
Measured: through study completion, an average of 1 year
operator satisfaction for each procedure
measure the amount of satisfaction using visual analogue scales distributed from 1 to 10, higher score means better outcome
Measured: through study completion, an average of 1 year
patient satisfaction for each procedure
measure the amount of satisfaction using visual analogue scales distributed from 1 to 10, higher score means better outcome
Measured: through study completion, an average of 1 year
Number of Participants with repeated paracentesis
Whether to do paracentesis again due to initial failure or catheter dislocation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start17 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ascites HepaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- multi-center, prospective, interventional study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sang Gyune Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sang Gyune Kim, Soonchunhyang University Hospital
- Investigators
- Sang gyune Kim, PhD, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578573
- Sponsor's protocol ID
- KARAHOC STUDY
- Status last verified
- Oct 2022
- First submitted
- 16 Jan 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 24679494Moore 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.
PubMed 16966752Gentilini 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.
PubMed 10207805Gines 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.
PubMed 3297907Quintero 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.
PubMed 2857949Salerno 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.
PubMed 3655306Jeon SH, Heo NY, Maeng SA, Yoo HW, Yoo JJ, Kim YS, Park SH, Seo YS, Kim SG. A Novel Anchoring Catheter Improves the Success, Efficiency, and Satisfaction of Paracentesis in Refractory Ascites: A Multicenter Randomized Crossover Trial. J Gastroenterol Hepatol. 2026 Sep 3. doi: 10.1111/jgh.70716. Online ahead of print.
PubMed 42693590
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Success Rate and Complication Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis in Cirrhotic Patients With Ascites
- ClinicalTrials.gov ID
- NCT05578573
- Acronym / sponsor ID
- KARAHOC STUDY
- Conditions
- Ascites Hepatic
- Keywords
- paracentesis, cirrhosis, ascites
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sang Gyune KimUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi-center, prospective, interventional study
| Arm | Type | Receives |
|---|---|---|
| KARAHOC group | Experimental | Device: KARAHOC deviceA group of patients in which paracentesis will be performed using a KARAHOC device. |
| conventional group | Active comparator | Device: AngiocatheterA group of patients in which paracentesis will be performed using an angiocatheter. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KARAHOC deviceAfter 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. | Device | KARAHOC group |
| AngiocatheterAfter 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 | Device | conventional group |
Primary outcome
Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis
Time frame: 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.
4 secondary outcomes
comparison of complication rate
Time frame: through study completion, an average of 1 year
operator satisfaction for each procedure
Time frame: through study completion, an average of 1 year
patient satisfaction for each procedure
Time frame: through study completion, an average of 1 year
Number of Participants with repeated paracentesis
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 24679494Iwakiri 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.
- Background: PubMed 16966752Moore 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.
- Background: PubMed 10207805Gentilini 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.
- Background: PubMed 3297907Gines 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.
- Background: PubMed 2857949Quintero 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.
- Background: PubMed 3655306Salerno 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.
- Derived from this study: PubMed 42693590Jeon SH, Heo NY, Maeng SA, Yoo HW, Yoo JJ, Kim YS, Park SH, Seo YS, Kim SG. A Novel Anchoring Catheter Improves the Success, Efficiency, and Satisfaction of Paracentesis in Refractory Ascites: A Multicenter Randomized Crossover Trial. J Gastroenterol Hepatol. 2026 Sep 3. doi: 10.1111/jgh.70716. Online ahead of print.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang gyune Kim, PhD principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KARAHOC device and Angiocatheter in people with Ascites Hepatic, run by Sang Gyune Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of success rate between conventional angiocatheter versus KARAHOC device used for paracentesis (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05578573, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.