Background and Objectives: Successful tract dilation is one of the most important steps to accomplish EUS-guided drainage. Although mechanical dilation is safer than electrocautery dilation, no dedicated mechanical dilator (MD) is currently available. Thus, we developed a new ultra-tapered MD for EUS-guided drainage. This study aimed to evaluate the safety and usefulness of this novel MD. Patients and Methods: Consecutive patients who underwent EUS-guided hepaticogastrostomy (EUS-HGS) or EUS-guided pancreatic duct drainage (EUS-PD) at two centers were included in the study. Dilation of the needle tract was initially performed with a diathermic sheath or the ultra-tapered MD. Technical success and adverse events were assessed. Results: Sixty-four patients (mean age = 68.9 ± 13.8 years, 35 men) underwent EUS-HGS (49 patients) and EUS-PD (15 patients). Thirty-three patients were included in the cautery dilator (CD) group and 31 in the ultra-tapered MD group. Initial dilation of the puncture site was achieved in 95.3% (61/64): 97% (32/33) of the patients in the CD group and 93.3% (29/31) of the patients in the MD group (P > 0.05). Adverse events were observed in 14 patients: abdominal pain in 8 patients and bleeding in 6 patients at the puncture site. All bleedings occurred in the CD group and there was no patient in whom bleeding occurred after EUS intervention in the MD group (P = 0.04). Conclusion: The novel ultra-tapered MD designed for interventional EUS appears to be safe and useful as it reduced postprocedure bleeding with a high technical success rate compared with the conventional electrocautery dilator.
ASJC Scopus subject areas