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Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KARAHOC group | Experimental | A group of patients in which paracentesis will be performed using a KARAHOC device. |
|
| conventional group | Active Comparator | A group of patients in which paracentesis will be performed using an angiocatheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of complication rate | the frequency of bleeding, hypotension, acute kidney injury, infection | through study completion, an average of 1 year |
| operator satisfaction for each procedure |
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Inclusion Criteria:
Exclusion Criteria:(If at least one of the following conditions apply)
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| Name | Affiliation | Role |
|---|---|---|
| Sang gyune Kim, PhD | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24679494 | Background | 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. | |
| 16966752 | 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. |
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There is not a plan to make IPD available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2021 | Jan 13, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2021 | Jan 13, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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multi-center, prospective, interventional study
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| 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 |
|
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 |
| 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 |
| 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 |
| 10207805 | 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. |
| 3297907 | 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. |
| 2857949 | 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. |
| 3655306 | 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. |