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Informed consent in endoscopy: Read, understood, or just signed? 内窥镜检查中的知情同意:阅读、理解,还是仅仅签字?
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.04.001
Ana Catarina Carvalho MD , Ricardo Cardoso MD , Hugo Marcelo Vieira MD , Américo Silva MD

Background and Aims

Although informed consent is a requirement for all interventional procedures such as those in GI endoscopy, its standardization is a challenge. Very thorough documents have been proposed, but it is unknown whether patients actually read them. We evaluated if patients read and understand informed consent forms and information leaflets for GI endoscopy.

Methods

This single-center, prospective, observational study was performed between April 2021 and April 2022 and included adult patients proposed for outpatient elective EGD and colonoscopy. Informed consent forms and information leaflets were mailed to patients, with a small text instruction added to the informed consent form. Before endoscopy, we assessed whether patients adequately read the informed consent form, based on patient signature, table questionnaire completion, and performance of the text instruction.

Results

The study included 232 patients (50.6% men; mean age, 63.8 ± 12.76 years). Most had only a basic education (78.0%) and had previously undergone GI endoscopy (90.6%). Of the patients, 86.6% stated they had read the form and 13.4% did not. Although most signed the form (83.6%), only 24.6% adequately read and understood it. No statistically significant association between an adequate reading of the informed consent form and any of the assessed variables was found.

Conclusions

Despite the timely provision of information, most patients do not read or adequately understand the provided documents. It is necessary to develop new strategies to enhance patients’ involvement in decision-making, thus improving the doctor–patient relationship in obtaining informed consent. (Clinical trial registration number: NCT05414435.)

背景和目的虽然知情同意书是所有介入手术(如消化内镜手术)的必要条件,但其标准化却是一项挑战。虽然已经提出了非常详尽的文件,但患者是否真正阅读这些文件仍是未知数。我们评估了患者是否阅读并理解消化内镜检查的知情同意书和信息单。方法这项单中心、前瞻性、观察性研究于 2021 年 4 月至 2022 年 4 月间进行,研究对象包括拟在门诊择期接受胃肠道造影术和结肠镜检查的成年患者。我们向患者邮寄了知情同意书和信息宣传单,并在知情同意书上添加了小文字说明。内镜检查前,我们根据患者的签名、表格问卷的填写情况以及文字说明的执行情况,评估患者是否充分阅读了知情同意书。大多数患者仅受过基础教育(78.0%),以前接受过消化内镜检查(90.6%)。86.6%的患者表示已阅读过表格,13.4%的患者表示未阅读过表格。虽然大多数患者(83.6%)在表格上签了字,但只有 24.6% 的患者充分阅读并理解了表格。尽管及时提供了信息,但大多数患者并未阅读或充分理解所提供的文件。有必要制定新的策略来提高患者对决策的参与度,从而在获得知情同意的过程中改善医患关系。(临床试验注册号:NCT05414435)。
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引用次数: 0
Hemosuccus pancreaticus treated using EUS-guided coil embolization and glue injection 利用 EUS 引导下的线圈栓塞和胶水注射治疗胰腺脓肿
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.02.008
Harishankar Gopakumar MD, Hasan Shoaib MD, Srinivas R. Puli MD
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引用次数: 0
Dueling capsules: novel devices for GI bleeding diagnostics 决斗胶囊:用于消化道出血诊断的新型设备
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.04.018
Shuji Mitsuhashi MBBS, Andrew C. Storm MD
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引用次数: 0
“Through-stent enterography”: first experience with a novel technique intended to improve safety in endosonography-guided gastroenterostomy "穿刺胃肠造口术":首次使用旨在提高内窥镜引导下胃肠造口术安全性的新技术(附视频)。
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.04.006
Markus Heilmaier MD , Dominik Schulz MD , Christoph Schlag MD , Rami Abbassi MD , Mayada Elnegouly MD , Marc Ringelhan MD , Tobias Lahmer MD , Ulrich Mayr MD , Roland M. Schmid MD , Matthias Treiber MD , Mohamed Abdelhafez MD

Background and Aims

Endosonography-guided gastroenterostomy (EUS-GE) is a novel technique to manage symptoms of gastric outlet obstruction. Major challenges are the high mobility of intestinal loops and the transient loss of endosonographic visibility during the puncture. This can lead to stent misdeployment, which can be associated with potentially fatal adverse events. By injecting contrast medium through the guidewire channel of the lumen-apposing metal stent application system under fluoroscopic guidance, a positive enterogram can confirm the position of the stent inside the intestinal lumen before its deployment. The aim of this study was to describe this novel technique and to assess its feasibility.

Methods

The data of 39 consecutive patients undergoing EUS-GE with “through-stent-enterography” from July 2020 to March 2022 were retrospectively collected and analyzed. The primary end point was technical success. Secondary end points were adverse events, reinterventions, and clinical success.

Results

Technical success was achieved in all cases (n = 39). In 2 cases, a second puncture was required to place the stent successfully. In 1 case, misdeployment could be avoided after a negative enterogram. In the other case, misdeployment occurred despite a positive enterogram and reintervention was needed. Clinical success was achieved in 92.3% (n = 36). No major adverse events or mortalities were encountered.

Conclusions

“Through-stent enterography” after the puncture to confirm the correct position of the stent in the small bowel is a novel and simple technique that can potentially reduce the risk of misdeployment of the stent.

背景和目的内超声引导胃肠造口术(EUS-GE)是一种治疗胃出口梗阻症状的新技术。主要挑战在于肠套叠的高流动性和穿刺过程中内镜能见度的短暂丧失。这可能会导致支架错误部署,从而引发潜在的致命不良事件。在透视引导下,通过腔隙贴合金属支架应用系统的导丝通道注入造影剂,阳性肠造影可在支架部署前确认其在肠腔内的位置。方法回顾性收集并分析了 2020 年 7 月至 2022 年 3 月期间接受 EUS-GE 和 "通过支架肠造影 "的 39 例连续患者的数据。主要终点是技术成功率。结果所有病例均获得技术成功(39 例)。2例患者需要进行第二次穿刺才能成功置入支架。其中 1 例患者在肠造影呈阴性后避免了误置。在另一个病例中,尽管肠造影呈阳性,但还是发生了错置,需要重新介入。临床成功率为 92.3%(n = 36)。结论 在穿刺后进行 "穿刺支架肠造影 "以确认支架在小肠中的正确位置是一项新颖而简单的技术,有可能降低支架误部署的风险。
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引用次数: 0
Unveiling the unsealed: modified Zenker’s peroral endoscopic myotomy with open incision 揭开封印的面纱改良的 Zenker 口周内窥镜肌切开术与开放切口
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.04.004
Farimah Fayyaz MD, Eric Swei MD, Mouen Khashab MD
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引用次数: 0
Use of spray coagulation in first-space endoscopy: a case series 在第一空间内窥镜检查中使用喷雾凝固技术:病例系列
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.02.007
Marco Alburquerque MD, MSc , Alba Vargas MD , Cesar Ledezma MD , Antonella Smarrelli MD , Eva Pijoan MD , Montserrat Figa MD , Ferrán González-Huix MD, PhD
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引用次数: 0
Learning curve of EUS-guided biliary duct drainage: systematic review and meta-analysis 内镜超声引导下胆管引流术的学习曲线:系统回顾与 Meta 分析
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.02.009
Ishaan Vohra MD , Harishankar Gopakumar MD , Navjit Singh MD , Neil Sharma MD , Srinivas R. Puli MD

Background and Aims

In recent years, EUS-guided biliary drainage (EUS-BD) has emerged as an alternative to ERCP. However, a recent meta-analysis of randomized controlled trials suggests comparable efficacy and safety between EUS and conventional ERCP for biliary drainage, highlighting the growing preference for EUS-BD. This study aims to contribute to this evolving landscape by investigating the technical and clinical success of EUS-BD and defining its learning curve.

Methods

A comprehensive search of electronic databases was conducted from January 2003 to November 2022 for publications evaluating the learning curve of EUS-BD. Pooled proportions were calculated using both fixed-effects and random-effects models, with a 95% confidence interval.

Results

The initial search yielded 380 studies, of which 88 relevant articles were reviewed. Data from 3 studies (261 patients) meeting inclusion criteria were analyzed. Proficiency in EUS-BD was achieved at 35.51 procedures. Pooled technical success was 92.45%, and clinical success was 84.84%. Adverse events occurred in 18.46% of cases, with specific rates for bleeding (4.31%), perforation (3.03%), sepsis (7.61%), procedure-related death (.31%), and all-cause mortality (2.29%). No bias was detected using the Egger bias indicator, which gave a value of –6.0 with a P = .17.

Conclusions

Our analysis revealed an EUS-BD proficiency at around 35 procedures, with a mean postproficiency procedure length of 68.07 minutes. Adverse events notably decrease after 66 procedures, informing a safety-driven recommendation: Endosonographers should complete a minimum of 60 supervised procedures before independent EUS-BD practice, enhancing procedural safety and proficiency.

背景和目的近年来,EUS引导下胆道引流术(EUS-BD)已成为ERCP的替代方法。然而,最近一项随机对照试验的荟萃分析表明,EUS 和传统 ERCP 在胆道引流方面的疗效和安全性相当,这凸显了人们越来越倾向于 EUS-BD。本研究旨在通过调查 EUS-BD 的技术和临床成功率并定义其学习曲线,为这一不断发展的趋势做出贡献。方法从 2003 年 1 月到 2022 年 11 月,对电子数据库进行了全面检索,以获取评估 EUS-BD 学习曲线的出版物。采用固定效应和随机效应模型计算汇总比例,并得出 95% 的置信区间。结果初步检索共获得 380 项研究,对其中 88 篇相关文章进行了综述。对符合纳入标准的 3 项研究(261 名患者)的数据进行了分析。EUS-BD的熟练程度达到35.51次。汇总的技术成功率为 92.45%,临床成功率为 84.84%。18.46%的病例发生了不良事件,具体比率为出血(4.31%)、穿孔(3.03%)、败血症(7.61%)、手术相关死亡(0.31%)和全因死亡率(2.29%)。结论我们的分析显示,EUS-BD熟练程度约为35例手术,熟练后的平均手术时间为68.07分钟。66 例手术后不良事件明显减少,这为安全建议提供了依据:内镜技师在独立进行 EUS-BD 操作前至少应完成 60 个指导程序,以提高程序安全性和熟练程度。
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引用次数: 0
Freezing our way to a cure? 冷冻疗法?
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.04.013
Linda S. Lee MD , Bill Busby JD , Vivek Kaul MD
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引用次数: 0
A brave new world: building the endoscopic resection bridge between Japan and the United States 勇敢的新世界:在日本和美国之间架起内窥镜切除术的桥梁
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.04.012
Hiroyuki Aihara MD, PhD, FASGE , Phillip S. Ge MD
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引用次数: 0
How to incorporate endohepatology into your bariatric practice 如何将内科肝病纳入减肥实践
Pub Date : 2024-06-01 DOI: 10.1016/j.igie.2024.04.011
Pichamol Jirapinyo MD, MPH
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引用次数: 0
期刊
iGIE
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