A Novel Anchoring Catheter Improves the Success, Efficiency, and Satisfaction of Paracentesis in Refractory Ascites: A Multicenter Randomized Crossover Trial.

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.