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数字胆管镜(SpyGlass DS)在肝胆胰疾病中的应用:沙特阿拉伯两家三级护理中心的临床可行性研究(附有视频)。

The utility of digital cholangioscopy (SpyGlass DS) in biliary and pancreatic diseases: A clinical feasibility study at two tertiary care centers in Saudi Arabia (with Videos).

机构信息

King Fahad Medical City, Department of Gastroenterology and Hepatology, Riyadh, Saudi Arabia.

King Abdulaziz University, King Abdulaziz University Hospital, Department of Medicine, Jeddah, Saudi Arabia.

出版信息

Arab J Gastroenterol. 2020 Mar;21(1):49-53. doi: 10.1016/j.ajg.2019.12.003. Epub 2020 Mar 13.

Abstract

BACKGROUND AND STUDY AIM

Since its inception in 2007, single-operator cholangioscopy (SOC) has gained popularity for many diagnostically and therapeutically challenging biliary and pancreatic conditions. Many studies have been published to evaluate the feasibility, usefulness, cost-effectiveness, and safety profile of the first generation. This paper is a descriptive study in which we aim to share the experience of two tertiary care centers with the novel version of SOC, SpyGlass DS.

PATIENTS AND METHODS

We retrospectively reviewed the records of all the patients who went through the procedure from October 2015 - July 2019 to explore the scope of biliary and pancreatic conditions in which SOC was utilized. Technical success was defined as the ability to visualize the lesion and complete the procedure as planned, whereas clinical success was determined by the ability to achieve the desired diagnostic/therapeutic outcome.

RESULTS

During the period of interest, 66 patients (34 males) went through 84 cholangioscopy procedures. Forty-four patients failed the conventional extraction methods and needed the intervention for the treatment of difficult stones, 24 patients needed a diagnostic evaluation of biliary strictures, and 3 needed an intervention to remove migrated stents. Technical success was achieved in 98.8% (83/84) of the procedures (95% CI: 96-100%). Regarding clinical success, stone breakdown and removal was achieved in 92% of the procedures (49/53; 95% CI: 85-100%). Tissue samples were successfully obtained in 95.8% (23/24) of patients with strictures (95% CI: 88-100%). The biopsy was appropriate to make a histological diagnosis in 83.3% of cases (20/24; 95% CI: 68-98%). The median number of sessions needed to achieve the deisred outcome was one (ranging between 1 and 6 sessions).

CONCLUSION

The new version of SOC, SpyGlass DS, provides a feasible and an effective option for the management of difficult cholelithiasis, as well as visually evaluating and obtaining histological samples for indeterminate biliary strictures. However, data from more extensive studies are needed to establish its non-inferiority to the fiberoptic version in terms of short- and long-term outcomes, cost-effectiveness, and complications.

摘要

背景与研究目的

自 2007 年以来,单操作员胆管镜检查(SOC)在许多具有挑战性的胆道和胰腺疾病的诊断和治疗中越来越受欢迎。已经发表了许多研究来评估第一代产品的可行性、有用性、成本效益和安全性。本文是一项描述性研究,旨在分享两家三级保健中心使用新型 SOC(SpyGlass DS)的经验。

患者和方法

我们回顾性地查阅了 2015 年 10 月至 2019 年 7 月期间所有接受该手术的患者记录,以探讨 SOC 用于胆道和胰腺疾病的范围。技术成功定义为能够可视化病变并按计划完成手术,而临床成功则取决于实现所需诊断/治疗结果的能力。

结果

在研究期间,66 名患者(34 名男性)接受了 84 次胆管镜检查。44 名患者常规取石方法失败,需要介入治疗以治疗困难结石,24 名患者需要胆道狭窄的诊断评估,3 名患者需要介入以取出迁移支架。84 次手术中有 98.8%(83/84)(95%可信区间:96-100%)达到了技术成功。关于临床成功,49/53 例(92%;95%可信区间:85-100%)成功进行了碎石和取石。24 例狭窄患者中有 95.8%(23/24)成功获得组织样本(95%可信区间:88-100%)。活检结果在 83.3%的病例中(20/24;95%可信区间:68-98%)能做出组织学诊断。达到预期结果所需的平均治疗次数为 1 次(范围 1-6 次)。

结论

新型 SOC(SpyGlass DS)为治疗困难性胆石症以及对不确定的胆道狭窄进行视觉评估和获取组织学样本提供了一种可行且有效的选择。然而,需要更多广泛的研究来确定其在短期和长期结果、成本效益和并发症方面与纤维光学版本相比的非劣效性。

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