A Novel Anchoring Catheter Improves the Success, Efficiency, and Satisfaction of Paracentesis in Refractory Ascites: A Multicenter Randomized Crossover Trial
- 1Division of Gastroenterology and Hepatology, Department of Internal Medicine Soonchunhyang University Bucheon Hospital Bucheon Republic of Korea
- 2Department of Internal Medicine Inje University Haeundae Paik Hospital Busan Republic of Korea
- 3Department of Internal Medicine Korea University Anam Hospital Seoul Republic of Korea
Abstract
Background: Large‐volume paracentesis is the standard treatment for refractory ascites, but conventional angiocatheter (CA) use may be limited by kinking and dislodgement. KARAHOC (KH) is a multifenestrated over‐the‐needle catheter with an anchoring disc designed to improve catheter stability. We compared the efficacy and safety of KH with CA in cirrhotic patients with refractory ascites.
Methods: This prospective, multicenter, 2 × 2 randomized crossover trial enrolled 87 cirrhotic patients requiring repeated paracentesis at three Korean academic hospitals. Participants underwent paracentesis with both KH and CA in randomized order at least 7 days apart. Successful paracentesis was defined as drainage of ≥ 3 L of ascites. Patient and operator satisfaction were assessed using a visual analog scale.
Results: In the intention‐to‐treat analysis, success was higher with KH than with CA (87.5% vs. 71.6%; OR 2.78, 95% CI 1.22–6.30; p = 0.018), with shorter median procedure time (71 vs. 80 min; p = 0.018). Per‐protocol analysis showed similar results (91.9% vs. 77.0%; p = 0.015). Re‐puncture was less frequent with KH but was not statistically significant. Patient and operator satisfaction were significantly higher with KH (both p < 0.001). Adverse events were comparable, with no major complications.
Conclusion: KH improved paracentesis success, shortened procedure time, and increased satisfaction without compromising safety, supporting its use as a practical alternative to CA for repeated paracentesis in refractory ascites.
Trial Registration: ClinicalTrials.gov: NCT05578573
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BibTeX
@article{jeon2026novel,
title = {{A Novel Anchoring Catheter Improves the Success, Efficiency, and Satisfaction of Paracentesis in Refractory Ascites: A Multicenter Randomized Crossover Trial}},
author = {So Hyun Jeon and Nae‐Yun Heo and Seon Ah. Maeng and Hae won Yoo and Jeong‐Ju Yoo and Young Seok Kim and Seung Ha Park and Yeon Seok Seo and Sang Gyune Kim},
journal = {Journal of Gastroenterology and Hepatology},
year = {2026},
month = sep,
doi = {10.1111/jgh.70716},
url = {https://doi.org/10.1111/jgh.70716},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - A Novel Anchoring Catheter Improves the Success, Efficiency, and Satisfaction of Paracentesis in Refractory Ascites: A Multicenter Randomized Crossover Trial
AU - So Hyun Jeon
AU - Nae‐Yun Heo
AU - Seon Ah. Maeng
AU - Hae won Yoo
AU - Jeong‐Ju Yoo
AU - Young Seok Kim
AU - Seung Ha Park
AU - Yeon Seok Seo
AU - Sang Gyune Kim
PY - 2026
DA - 2026/09/03
JO - Journal of Gastroenterology and Hepatology
DO - 10.1111/jgh.70716
UR - https://doi.org/10.1111/jgh.70716
AB - Background: Large‐volume paracentesis is the standard treatment for refractory ascites, but conventional angiocatheter (CA) use may be limited by kinking and dislodgement. KARAHOC (KH) is a multifenestrated over‐the‐needle catheter with an anchoring disc designed to improve catheter stability. We compared the efficacy and safety of KH with CA in cirrhotic patients with refractory ascites. Methods: This prospective, multicenter, 2 × 2 randomized crossover trial enrolled 87 cirrhotic patients requiring repeated paracentesis at three Korean academic hospitals. Participants underwent paracentesis with both KH and CA in randomized order at least 7 days apart. Successful paracentesis was defined as drainage of ≥ 3 L of ascites. Patient and operator satisfaction were assessed using a visual analog scale. Results: In the intention‐to‐treat analysis, success was higher with KH than with CA (87.5% vs. 71.6%; OR 2.78, 95% CI 1.22–6.30; p = 0.018), with shorter median procedure time (71 vs. 80 min; p = 0.018). Per‐protocol analysis showed similar results (91.9% vs. 77.0%; p = 0.015). Re‐puncture was less frequent with KH but was not statistically significant. Patient and operator satisfaction were significantly higher with KH (both p < 0.001). Adverse events were comparable, with no major complications. Conclusion: KH improved paracentesis success, shortened procedure time, and increased satisfaction without compromising safety, supporting its use as a practical alternative to CA for repeated paracentesis in refractory ascites. Trial Registration: ClinicalTrials.gov: NCT05578573
SN - 0815-9319
SN - 1440-1746
ER -