Novel 8-wire basket catheter is useful for endoscopic removal of common bile duct stones up to 10 mm: A multicenter prospective study

IF 3.2 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Journal of Hepato‐Biliary‐Pancreatic Sciences Pub Date : 2024-01-04 DOI:10.1002/jhbp.1400

Takashi Kaneko, Tomohiro Ishii, Jun Hamanaka, Yoshihiro Goda, Kuniyasu Irie, Nobutaka Doba, Yosuke Kunishi, Haruo Miwa, Kazuya Sugimori, Shin Maeda

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Abstract

Background/Purpose

Endoscopic treatment of common bile duct (CBD) stones involves the use of basket or balloon catheters; however, what is the appropriate device remains controversial. In this study we aimed to prospectively evaluate the usefulness of a novel 8-wire helical basket (8WB) catheter made of Nitinol for the removal of CBD stones ≤10 mm.

Methods

We conducted a multicenter prospective trial. Patients with CBD stones ≤10 mm were enrolled. The primary endpoint was the rate of complete stone removal within 10 min using the 8WB. The number of cases was determined using a previous study of stone removal by a conventional basket catheter as a historical control.

Results

A total of 155 patients were enrolled and 139 were ultimately included in the analysis. Patients with a single stone were the most common (84 cases, 60.4%), with a median maximum stone diameter of 5 mm. The median stone removal time using the 8WB was 6 min. The complete stone removal rate was 95.0% (132/139). Adverse events were observed in 14 patients (10.1%).

Conclusions

The novel 8WB catheter is useful in the treatment of CBD stones ≤10 mm, presenting a high complete stone removal rate in this study.

Trial registration number: jRCT1032200324.

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新型 8 线篮式导管可用于内镜下清除 10 毫米以内的胆总管结石：一项多中心前瞻性研究。

背景/目的：胆总管（CBD）结石的内镜治疗包括使用篮式或球囊导管；然而，什么是合适的设备仍存在争议。在这项研究中，我们旨在前瞻性地评估镍钛诺制成的新型 8 线螺旋篮式（8WB）导管在清除≤10 毫米的胆总管结石方面的实用性：我们进行了一项多中心前瞻性试验。方法：我们进行了一项多中心前瞻性试验，招募了CBD结石≤10毫米的患者。主要终点是使用 8WB 在 10 分钟内完全清除结石的比率。病例数是以之前使用传统篮式导管清除结石的研究作为历史对照来确定的：结果：共有 155 名患者入选，最终有 139 名患者被纳入分析。单发结石患者最多（84 例，60.4%），结石最大直径中位数为 5 毫米。使用 8WB 取石的中位时间为 6 分钟。结石完全清除率为 95.0%（132/139）。14名患者（10.1%）出现了不良反应：结论：新型8WB导管适用于治疗≤10毫米的CBD结石，在本研究中结石完全清除率很高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Hepato‐Biliary‐Pancreatic Sciences GASTROENTEROLOGY & HEPATOLOGY-SURGERY

自引率

10.00%

发文量

178

审稿时长

6-12 weeks

期刊介绍： The Journal of Hepato-Biliary-Pancreatic Sciences (JHBPS) is the leading peer-reviewed journal in the field of hepato-biliary-pancreatic sciences. JHBPS publishes articles dealing with clinical research as well as translational research on all aspects of this field. Coverage includes Original Article, Review Article, Images of Interest, Rapid Communication and an announcement section. Letters to the Editor and comments on the journal’s policies or content are also included. JHBPS welcomes submissions from surgeons, physicians, endoscopists, radiologists, oncologists, and pathologists.