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.