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- Title
Efficacy and Safety of a Novel Tapered-Tip Sheath System for Biliary-Lesion Tissue Sampling: A Randomized Controlled Trial.
- Authors
Hirokazu Okada; Norimitsu Uza; Tomoaki Matsumori; Hajime Yamazaki; Muneji Yasuda; Takeshi Kuwada; Yoshihiro Nishikawa; Takahisa Maruno; Masahiro Shiokawa; Atsushi Takai; Ken Takahashi; Akihisa Fukuda; Etsuro Hatano; Sachiko Minamiguchi; Hiroshi Seno
- Abstract
Background/Aims: Pathological evaluation is crucial for diagnosing biliary lesions and deter- mining appropriate treatment strategies. However, tissue sampling via the transpapillary route can be difficult. In this study, we aimed to assess the efficacy and safety of a novel tapered-tip sheath system for tissue sampling from biliary strictures. Methods: This single-center, randomized, parallel-group clinical trial included patients aged 20 to 85 years admitted to Kyoto University Hospital for biliary strictures. The patients were randomly assigned (1:1) to a new or conventional method group. The primary outcome was technical success of biopsy at the target bile duct using the assigned method, as determined in accordance with the intention-to-treat principle. Adverse events were assessed in all eligible patients. Results: Fifty-six patients were assessed for eligibility between September 2020 and March 2023; 50 patients were enrolled. The patients were randomly divided into the new (n=25) method group and the conventional (n=25) method group. Technical success was achieved in 96.0% (24/25) and 48.0% (12/25) of patients in the new and conventional method groups, respectively (risk ratio, 2.00; 95% confidence interval [CI], 1.32 to 3.03; risk difference, 48.0%; 95% CI, 27.0% to 69.0%; p<0.001). Adverse events occurred in 4.0% (1/25) and 36.0% (9/25) of patients in the new and conventional method groups, respectively (risk ratio, 0.11; 95% CI, 0.02 to 0.81; risk difference, –32.0%; 95% CI, –52.3% to –11.7%; p=0.005). Conclusions: The novel tapered-tip sheath system is a promising option for precisely and safely delivering biopsy forceps to target sites, thereby facilitating the diagnosis of biliary strictures.
- Subjects
BILE ducts; RANDOMIZED controlled trials; UNIVERSITY hospitals; CONFIDENCE intervals; CLINICAL trials
- Publication
Gut & Liver, 2025, Vol 19, Issue 1, p136
- ISSN
1976-2283
- Publication type
Academic Journal
- DOI
10.5009/gnl240349