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使用可弯曲支架进行胃十二指肠支架置入术尽管会逐渐扩张但仍显示出良好的临床疗效:一项多中心前瞻性研究。

Gastroduodenal Stenting with a Flexible Stent Demonstrates Favorable Clinical Effectiveness despite Gradual Expansion: A Multicenter Prospective Study.

作者信息

Shigoka Hiroaki, Toki Masao, Takahashi Sho, Takahara Naminatsu, Kitamura Katsuya, Iwasaki Eisuke, Nakahara Kazunari, Isayama Hiroyuki, Nakai Yousuke, Maetani Iruru

机构信息

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo 153-8515, Japan.

Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo 181-8611, Japan.

出版信息

J Clin Med. 2023 Jan 20;12(3):850. doi: 10.3390/jcm12030850.

Abstract

AIMS

This study aimed to evaluate the effectiveness and safety of stenting with a flexible braided self-expandable metal stent (SEMS) for unresectable malignant gastric outlet obstruction (GOO).

METHODS

Palliative stenting was prospectively carried out at seven university hospitals between October 2017 and August 2020. All procedures were performed using a flexible branded SEMS of the same brand. The primary endpoint was clinical success rate at 7 days after stenting. Secondary endpoints were procedural success rate, adverse events, recurrent gastric outlet obstruction (RGOO), and patient survival time.

RESULTS

Sixty patients were enrolled. The procedural and clinical success rates were 100% and 90%, respectively. RGOO occurred in 15 cases (25%). Adverse events other than RGOO were found in seven cases (12%). The 50% survival time was 75.5 days (range: 52-97 days). Median expansion rates at 1, 3, and 7 days after stenting were 55%, 65%, and 75%, respectively.

CONCLUSIONS

A flexible braided stent woven with relatively thin wires was used for malignant GOO. Despite a gradual expansion with slightly lower expansile force, the stent functioned sufficiently well and showed favorable results. Clinical Trials Registry ID: UMIN000029496.

摘要

目的

本研究旨在评估使用柔性编织自膨式金属支架(SEMS)治疗不可切除的恶性胃出口梗阻(GOO)的有效性和安全性。

方法

2017年10月至2020年8月期间,在七家大学医院前瞻性地开展了姑息性支架置入术。所有手术均使用同一品牌的柔性品牌SEMS进行。主要终点是支架置入术后7天的临床成功率。次要终点是手术成功率、不良事件、复发性胃出口梗阻(RGOO)和患者生存时间。

结果

共纳入60例患者。手术成功率和临床成功率分别为100%和90%。15例(25%)发生RGOO。7例(12%)出现了除RGOO之外的不良事件。50%的生存时间为75.5天(范围:52 - 97天)。支架置入后1天、3天和7天的中位扩张率分别为55%、65%和75%。

结论

使用相对细的金属丝编织的柔性编织支架治疗恶性GOO。尽管扩张力稍低且为逐渐扩张,但该支架功能良好且效果良好。临床试验注册编号:UMIN000029496。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0290/9918094/52f8a911606d/jcm-12-00850-g001.jpg

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