BACKGROUND AND AIMS:ERCP-guided biliary stenting is the usual palliative treatment for patients with unresectable malignant biliary obstruction (MBO). Previous studies suggested that ES prior to biliary stenting may not reduce the post-ERCP pancreatitis (PEP) risk and may increase bleeding risk. This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of ES prior to biliary stenting in patients with MBO, with a particular focus on the impact of MBO etiology and stent type. METHODS:We systematically searched for randomized controlled trials (RCTs) comparing ERCP-guided biliary stenting with versus without ES in patients with MBO. We estimated the pooled risk ratios (RRs) with respective 95% confidence intervals (CIs) using a random-effects model. RESULTS:Six RCTs (1215 patients) were included. Technical success and the risk of PEP, clinically significant bleeding, perforation, cholangitis, cholecystitis, and stent malfunction were similar between the groups. Subgroup analyses by MBO etiology and stent type were consistent with overall analysis, except for PEP by MBO etiology. ES reduced PEP risk in studies with a low prevalence of pancreatic cancer (RR 0.23; 95% CI 0.12-0.44), but no significant difference was observed in studies with a high prevalence of pancreatic cancer (RR 0.85; 95% CI 0.57-1.28). CONCLUSION:The risk of clinically significant bleeding was similar with or without ES prior to biliary stenting for MBO. ES was associated with a reduced PEP risk in studies with a low prevalence of pancreatic cancer, whereas no benefit was observed in studies with a high prevalence of pancreatic cancer.
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.
