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Current Engineering Developments for Robotic Systems in Flexible Endoscopy 柔性内窥镜中机器人系统的最新工程进展
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2022.11.006
Amirhosein Alian, Emilia Zari, Zeyu Wang, Enrico Franco, James P. Avery, Mark Runciman, Benny Lo, Ferdinando Rodriguez y Baena, George Mylonas

The past four decades have seen an increase in the incidence of early-onset gastrointestinal cancer. Because early-stage cancer detection is vital to reduce mortality rate, mass screening colonoscopy provides the most effective prevention strategy. However, conventional endoscopy is a painful and technically challenging procedure that requires sedation and experienced endoscopists to be performed. To overcome the current limitations, technological innovation is needed in colonoscopy. In recent years, researchers worldwide have worked to enhance the diagnostic and therapeutic capabilities of endoscopes. The new frontier of endoscopic interventions is represented by robotic flexible endoscopy. Among all options, self-propelling soft endoscopes are particularly promising thanks to their dexterity and adaptability to the curvilinear gastrointestinal anatomy. For these devices to replace the standard endoscopes, integration with embedded sensors and advanced surgical navigation technologies must be investigated. In this review, the progress in robotic endoscopy was divided into the fundamental areas of design, sensing, and imaging. The article offers an overview of the most promising advancements on these three topics since 2018. Continuum endoscopes, capsule endoscopes, and add-on endoscopic devices were included, with a focus on fluid-driven, tendon-driven, and magnetic actuation. Sensing methods employed for the shape and force estimation of flexible endoscopes were classified into model- and sensor-based approaches. Finally, some key contributions in molecular imaging technologies, artificial neural networks, and software algorithms are described. Open challenges are discussed to outline a path toward clinical practice for the next generation of endoscopic devices.

在过去的四十年中,早发性癌症的发病率有所上升。由于早期癌症检测对降低死亡率至关重要,因此大规模筛查结肠镜检查提供了最有效的预防策略。然而,传统的内窥镜检查是一种痛苦且具有技术挑战性的手术,需要镇静和经验丰富的内窥镜医生。为了克服目前的局限性,结肠镜检查需要技术创新。近年来,世界各地的研究人员致力于提高内窥镜的诊断和治疗能力。内窥镜干预的新前沿是机器人柔性内窥镜。在所有选择中,自推进软内窥镜由于其灵活性和对曲线胃肠解剖结构的适应性而特别有前景。为了让这些设备取代标准内窥镜,必须研究与嵌入式传感器和先进的手术导航技术的集成。在这篇综述中,机器人内窥镜检查的进展被分为设计、传感和成像的基本领域。这篇文章概述了自2018年以来在这三个主题上最有希望的进展。包括连续内窥镜、胶囊内窥镜和附加内窥镜设备,重点是流体驱动、肌腱驱动和磁驱动。用于柔性内窥镜形状和力估计的传感方法分为基于模型的方法和基于传感器的方法。最后,介绍了分子成像技术、人工神经网络和软件算法方面的一些关键贡献。讨论了悬而未决的挑战,为下一代内窥镜设备的临床实践勾勒出一条道路。
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引用次数: 0
Cold Snare Cut Versus Avulsion for Colonic Mucosal Resection: A Randomized Ex Vivo Porcine Study (the CONVINCE Study) 冷圈套切与撕脱结肠粘膜切除术:一项随机离体猪研究(说服研究)
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2023.05.001
Neal A. Mehta , James K. Stone , Roberto Trasolini , Yuho Ono , Mandeep S. Sawhney

Background and Aims

Cold snare polypectomy can only be used for en-bloc resection of small lesions. We describe a new technique, cold snare avulsion, where a cold snare is closed tightly, and traction, at times with substantial force, is applied to resect the ensnared tissue. We aimed to determine the feasibility and safety for lesions up to 15 mm.

Methods

A randomized study in ex-vivo porcine colons comparing en-bloc resection (successful mucosal entrapment and resection in one piece) and perforation rate for cold snare cut vs cold snare avulsion for lesions (1) 10 mm without submucosal injection, (2) 10 mm with submucosal injection, and (3) 15 mm with submucosal injection. Mucosal defects were endoscopically examined, and full-thickness punch biopsies were performed to determine histological depth and completeness of resection.

Results

For 10-mm lesions without submucosal injection, en-bloc resection occurred in 1 of 15 (6.7%) with cold snare cut vs 10 of 15 (66.7%; P = 0.002) with cold snare avulsion. For 10-mm lesions with submucosal injection, en-bloc resection occurred in 9 of 15 (60%) with cold snare cut vs 14 of 15 (93.3%; P = 0.08) with cold snare avulsion. For 15-mm lesions with submucosal injection, en-bloc resection occurred in 1 of 15 (6.7%) with cold snare cut vs 12 of 14 (85.7%; P < 0.001) with cold snare avulsion. No perforations occurred. Resection to the level of the submucosa was confirmed by histologic analysis of the mucosal defect in all but one case.

Conclusion

In an ex-vivo animal model, cold snare avulsion was superior to cold snare cut for complete en-bloc resection of lesions up to 15 mm, with no adverse outcomes reported.

背景与目的圈套器息肉切除术只能用于小病灶的整体切除。我们描述了一种新技术,冷圈套器撕脱术,将冷圈套器紧紧闭合,并施加牵引力,有时会施加很大的力来切除被诱捕的组织。我们的目的是确定15 mm以下病变的可行性和安全性。方法在离体猪结肠中进行一项随机研究,比较整体切除(成功的粘膜包埋和一体切除)和冷圈套器切口与冷圈套器撕脱伤的穿孔率,和(3)粘膜下注射15毫米。对粘膜缺损进行内镜检查,并进行全层穿孔活检,以确定组织学深度和切除的完整性。结果对于未经黏膜下注射的10mm病变,15例冷圈套器切口中有1例(6.7%)发生整体切除,15例中有10例(66.7%;P=0.002)发生冷圈套器撕脱伤。对于粘膜下注射的10mm病变,15例冷圈套器切口中有9例(60%)发生了整体切除,而15例冷诱捕器撕脱伤中有14例(93.3%;P=0.08)发生。对于粘膜下注射的15mm病变,15例冷圈套器切口中有1例(6.7%)发生了整体切除,而14例冷圈套术中有12例(85.7%;P<;0.001)发生了撕脱。没有穿孔。除一例外,所有病例均通过粘膜缺损的组织学分析证实切除至粘膜下层。结论在离体动物模型中,冷圈套器撕脱术优于冷圈套器切开术,可完整切除15 mm以下的病变,无不良结果报告。
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引用次数: 0
Early Enteral Feeding in Severe Acute Pancreatitis: A Randomized Clinical Trial Between Gastric vs Distal Jejunal Feeding 重症急性胰腺炎早期肠内喂养:胃与空肠远端喂养的随机临床试验
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2023.06.002
Stephen J.D. O'Keefe , Toby Graham , Gregory A. Coté , David C. Whitcomb , Anna Evans , Devavrata Soni , (Study of Nutrition in Acute Pancreatitis) Consortium

Background and Aims

Severe acute pancreatitis is one of the most catabolic illnesses. Meta-analyses have shown that enteral nutrition is safer and more effective than parenteral nutrition in suppressing these losses. However, there is intense debate about how the enteral nutrition should be delivered.

Methods

The design was a randomized controlled trial of early nasogastric (NG) vs distal jejunal (DJ) tube feeding with a semi-elemental diet during the first 4 weeks of severe acute pancreatitis. The setting involved multiple national tertiary care centers. Two hundred and twenty-eight patients were screened, and 26 met the inclusion criteria for new onset severe acute pancreatitis based on an APACHE II score >8, computed tomography evidence of >30% necrosis or computed tomography score >8, and/or a Marshall score >2. The intervention was a randomized allocation to either feeding tube bedside placement by NG or transnasal endoscopy for DJ. The primary endpoint was “feeding failure” to tolerate a rate of >10% of the goal for a 48-hour period.

Results

Twenty-six eligible patients were randomized, 12 to NG and 14 to DJ, 20 of 26 from the Pittsburgh center. Most were obese (BMI 31.5 kg/m2). Feeding failure occurred in 0 of 14 in the DJ group and in 6 of 11 (55%) in the NG group (P = 0.0026). NG failures were crossed over to DJ feeding with good tolerance and eventual recovery. As a result, the quantity of feed delivered was significantly higher in the DJ group (P < 0.05). Serious adverse events (cardiorespiratory arrests, unrelated to endoscopy) occurred in 2 of the DJ and none of the NG group; 3 patients from the DJ group died of progressive organ failure, 2 with associated compartment syndrome.

Conclusion

This randomized controlled trial indicates that in patients with acute pancreatitis of this level of severity, NG feeding will be ineffective. Although this is a common indication for parenteral nutrition, a safer alternative would be endoscopic-assisted DJ feeding tube placement to bypass the usually dysfunctional or obstructed upper gastrointestinal tract.

背景与目的严重急性胰腺炎是分解代谢最严重的疾病之一。荟萃分析表明,肠内营养在抑制这些损失方面比肠外营养更安全、更有效。然而,关于肠内营养应该如何提供,存在着激烈的争论。方法在重症急性胰腺炎的前4周,采用半元素饮食进行早期鼻胃(NG)管饲与远端空肠(DJ)管饲的随机对照试验。该环境涉及多个国家三级护理中心。筛选了228名患者,其中26名符合基于APACHE II评分>;8、>;30%坏死或计算机断层扫描评分>;8和/或马歇尔分数>;2.干预措施是随机分配到NG或DJ经鼻内镜下放置饲管的床边。主要终点是“喂养失败”,耐受率>;在48小时内达到目标的10%。结果26例符合条件的患者随机分为12例NG和14例DJ,其中20例来自匹兹堡中心。大多数是肥胖(BMI 31.5kg/m2)。DJ组14例中有0例发生喂养失败,NG组11例中有6例(55%)发生喂养失败(P=0.0026)。NG失败与DJ喂养交叉,耐受性良好,最终恢复。结果,DJ组的饲料输送量显著增加(P<;0.05)。DJ组中有2例发生严重不良事件(心肺骤停,与内窥镜检查无关),NG组中没有一例发生;DJ组3例死于进行性器官衰竭,2例伴有相关隔室综合征。结论本随机对照试验表明,在这种严重程度的急性胰腺炎患者中,NG喂养是无效的。尽管这是肠外营养的常见适应症,但更安全的替代方案是内镜辅助DJ饲管放置,以绕过通常功能失调或阻塞的上消化道。
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引用次数: 0
Reducing Disparities and Achieving Health Equity in Colorectal Cancer Screening 减少结直肠癌癌症筛查中的差异和实现健康公平。
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2023.02.007
Abraham Segura , Shazia Mehmood Siddique

Increases in colorectal cancer screening are linked to the declining incidence of the disease over the past 3 decades. These favorable trends, however, are not observed in marginalized racial and ethnic populations with disproportionately lower rates of screening, higher disease incidence, and increased mortality, despite advances in health technology and policy. This review describes the differences in screening uptake and test selection among racial and ethnic groups, discusses known obstacles and facilitators that impact screening, and highlights existing frameworks developed to achieve health equity in colorectal cancer screening.

癌症筛查的增加与过去三十年来该疾病发病率的下降有关。然而,尽管卫生技术和政策取得了进步,但在筛查率低得不成比例、疾病发病率高得不成比例、死亡率增加的边缘化种族和族裔人群中,并没有观察到这些有利趋势。这篇综述描述了种族和民族群体在筛查接受和检测选择方面的差异,讨论了影响筛查的已知障碍和促进因素,并强调了为实现癌症筛查的健康公平而制定的现有框架。
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引用次数: 0
Adherence to Quality Indicators for Diagnosis and Surveillance of Barrett's Esophagus: A Comparative Study of Barrett's Experts and Nonexperts Barrett食管诊断和监测质量指标的依从性:Barrett专家和非专家的比较研究
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2023.02.008
Domenico A. Farina , Claire A. Beveridge , Leila Kia , Elizabeth Gray , Srinadh Komanduri

Background and Aims

There is considerable variability in adherence to endoscopic quality indicators (QIs) for Barrett's esophagus (BE). The aims of this study were to (1) assess adherence to published Qis for diagnosis and surveillance of BE, (2) compare adherence between BE experts and nonexperts, and (3) identify factors associated with adherence.

Methods

We identified all patients with BE on esophagogastroduodenoscopy between 2010 and 2018. QIs evaluated included inspection using high-definition white light endoscopy, use of the Prague Classification, identification of endoscopic landmarks, use of the Seattle Protocol, and guideline-adherent recommendations for surveillance or endoscopic eradication therapy. BE experts and nonexperts were compared using logistic mixed-effects models.

Results

A total of 467 patients were identified, with BE experts performing fewer overall esophagogastroduodenoscopies (n = 162, 34.7% vs n = 305, 65.3%). Whereas BE experts were more likely to document Prague Classification (52.5% vs 41.3%; P = 0.017) and landmarks (43.2% vs 22.6%; P = 0.036), there was no significant difference between experts and nonexperts in use of high-definition white light endoscopy (8.6% vs 3.3%; P = 0.123), Seattle Protocol (48.1% vs 40.3%; P = 0.313), or guideline-adherent surveillance or treatment recommendations (71.0% vs 67.5%; P = 0.509). Patient enrollment in a BE surveillance program was the only factor associated with improved QI adherence, specifically adherence to Prague Classification documentation (OR 1.85, 95% CI 1.08-3.14; P = 0.025), Seattle Protocol (1.28, 95% CI 1.16-1.50; P < 0.001), and follow-up recommendations (OR 2.64, 95% CI 1.55-4.48; P < 0.001).

Conclusion

Patterns of adherence to published QIs for endoscopy in patients with BE are mostly independent of expertise. Further training initiatives are needed to standardize the performance of endoscopic practice in patients with BE.

背景和目的Barrett食管(BE)内镜质量指标(QIs)的依从性存在相当大的差异。本研究的目的是(1)评估对已发表的用于BE诊断和监测的Qis的依从性,(2)比较BE专家和非专家之间的依从性;(3)确定与依从性相关的因素。方法我们确定了2010年至2018年间所有接受食管胃十二指肠镜检查的BE患者。评估的QIs包括使用高清晰度白光内窥镜检查、布拉格分类法的使用、内窥镜标志物的识别、西雅图方案的使用以及监测或内窥镜根除治疗的指南遵循建议。BE专家和非专家使用逻辑混合效应模型进行比较。结果共发现467例患者,BE专家进行的食管胃十二指肠镜检查较少(n=162,34.7%vs n=305,65.3%)。而BE专家更有可能记录布拉格分类(52.5%vs 41.3%;P=0.017)和标志(43.2%vs 22.6%;P=0.036),专家和非专家在使用高清白光内窥镜检查(8.6%vs 3.3%;P=0.123)、西雅图方案(48.1%vs 40.3%;P=0.313)或指南依从性监测或治疗建议(71.0%vs 67.5%;P=0.509)方面没有显著差异。BE监测项目的患者登记是改善QI依从性的唯一因素,特别是遵守布拉格分类文件(OR 1.85,95%CI 1.08-3.14;P=0.025)、西雅图方案(1.28,95%CI1.16-1.50;P<;0.001)和随访建议(OR 2.64,95%CI1.55-4.48;P<)。需要进一步的培训举措来规范BE患者的内镜实践。
{"title":"Adherence to Quality Indicators for Diagnosis and Surveillance of Barrett's Esophagus: A Comparative Study of Barrett's Experts and Nonexperts","authors":"Domenico A. Farina ,&nbsp;Claire A. Beveridge ,&nbsp;Leila Kia ,&nbsp;Elizabeth Gray ,&nbsp;Srinadh Komanduri","doi":"10.1016/j.tige.2023.02.008","DOIUrl":"https://doi.org/10.1016/j.tige.2023.02.008","url":null,"abstract":"<div><h3>Background and Aims</h3><p>There is considerable variability in adherence to endoscopic quality indicators (QIs) for Barrett's esophagus (BE). The aims of this study were to (1) assess adherence to published Qis for diagnosis and surveillance of BE, (2) compare adherence between BE experts and nonexperts, and (3) identify factors associated with adherence.</p></div><div><h3>Methods</h3><p><span>We identified all patients with BE on esophagogastroduodenoscopy between 2010 and 2018. QIs evaluated included inspection using high-definition white light </span>endoscopy<span>, use of the Prague Classification, identification of endoscopic landmarks, use of the Seattle Protocol, and guideline-adherent recommendations for surveillance or endoscopic eradication therapy. BE experts and nonexperts were compared using logistic mixed-effects models.</span></p></div><div><h3>Results</h3><p>A total of 467 patients were identified, with BE experts performing fewer overall esophagogastroduodenoscopies (n = 162, 34.7% vs n = 305, 65.3%). Whereas BE experts were more likely to document Prague Classification (52.5% vs 41.3%; <em>P</em> = 0.017) and landmarks (43.2% vs 22.6%; <em>P</em><span> = 0.036), there was no significant difference between experts and nonexperts in use of high-definition white light endoscopy (8.6% vs 3.3%; </span><em>P</em> = 0.123), Seattle Protocol (48.1% vs 40.3%; <em>P</em><span> = 0.313), or guideline-adherent surveillance or treatment recommendations (71.0% vs 67.5%; </span><em>P</em> = 0.509). Patient enrollment in a BE surveillance program was the only factor associated with improved QI adherence, specifically adherence to Prague Classification documentation (OR 1.85, 95% CI 1.08-3.14; <em>P</em> = 0.025), Seattle Protocol (1.28, 95% CI 1.16-1.50; <em>P</em> &lt; 0.001), and follow-up recommendations (OR 2.64, 95% CI 1.55-4.48; <em>P</em> &lt; 0.001).</p></div><div><h3>Conclusion</h3><p>Patterns of adherence to published QIs for endoscopy in patients with BE are mostly independent of expertise. Further training initiatives are needed to standardize the performance of endoscopic practice in patients with BE.</p></div>","PeriodicalId":36169,"journal":{"name":"Techniques and Innovations in Gastrointestinal Endoscopy","volume":"25 3","pages":"Pages 204-212"},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49749694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Polypectomy Techniques for Pedunculated and Nonpedunculated Polyps 有柄和无柄息肉的息肉切除技术
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2023.02.006
Karl Kwok , Sasan Mosadeghi , Daniel Lew

Colonoscopic polypectomy, when performed appropriately and completely, reduces subsequent risk of colorectal cancer. However, performance of high-quality polypectomy varies widely among endoscopists based on many factors, from exposure during fellowship to continuing education once in practice. Thus, this review is intended for a wide audience, from gastroenterology trainees to practicing physicians. A review of electrosurgery principles is included to cover effective polypectomy techniques and to prevent and troubleshoot problems.

Similarly, successful colon polypectomy is heavily dependent on both anatomic position and endoscopic clock-face position within the colon. As a result, both equipment choice and hand technique are discussed, and specific tips are offered to maximize the likelihood of success. Additionally, within this review, we highlight several of the latest advances within the field of polypectomy, such as submucosal injection (including choice of fluid), dynamic injection technique, a thorough discussion on hot vs cold snare, site management, and complication management. Lastly, we explore why incomplete polypectomy occurs, the implications of incomplete polypectomy, and methods to reduce this risk.

结肠镜下息肉切除术,在适当和完全的情况下,可降低随后患结直肠癌癌症的风险。然而,高质量息肉切除术的表现在内镜医生之间存在很大差异,这取决于许多因素,从联谊期间的接触到实践中的继续教育。因此,这篇综述面向广泛的受众,从胃肠病学实习生到执业医生。综述了电外科原理,包括有效的息肉切除术技术以及预防和解决问题。同样,结肠息肉切除术的成功在很大程度上取决于结肠内的解剖位置和内镜钟面位置。因此,讨论了设备的选择和手的技术,并提供了具体的技巧,以最大限度地提高成功的可能性。此外,在这篇综述中,我们强调了息肉切除术领域的一些最新进展,如粘膜下注射(包括液体的选择)、动态注射技术、对冷热圈套器的彻底讨论、部位管理和并发症管理。最后,我们探讨了不完全性息肉切除术发生的原因、不完全性切除术的意义以及降低这种风险的方法。
{"title":"Polypectomy Techniques for Pedunculated and Nonpedunculated Polyps","authors":"Karl Kwok ,&nbsp;Sasan Mosadeghi ,&nbsp;Daniel Lew","doi":"10.1016/j.tige.2023.02.006","DOIUrl":"https://doi.org/10.1016/j.tige.2023.02.006","url":null,"abstract":"<div><p>Colonoscopic polypectomy<span>, when performed appropriately and completely, reduces subsequent risk of colorectal cancer. However, performance of high-quality polypectomy varies widely among endoscopists based on many factors, from exposure during fellowship to continuing education once in practice. Thus, this review is intended for a wide audience, from gastroenterology<span> trainees to practicing physicians. A review of electrosurgery principles is included to cover effective polypectomy techniques and to prevent and troubleshoot problems.</span></span></p><p>Similarly, successful colon polypectomy is heavily dependent on both anatomic position and endoscopic clock-face position within the colon. As a result, both equipment choice and hand technique are discussed, and specific tips are offered to maximize the likelihood of success. Additionally, within this review, we highlight several of the latest advances within the field of polypectomy, such as submucosal injection (including choice of fluid), dynamic injection technique, a thorough discussion on hot vs cold snare, site management, and complication management. Lastly, we explore why incomplete polypectomy occurs, the implications of incomplete polypectomy, and methods to reduce this risk.</p></div>","PeriodicalId":36169,"journal":{"name":"Techniques and Innovations in Gastrointestinal Endoscopy","volume":"25 4","pages":"Pages 361-371"},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49749839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Analysis of Reported Adverse Events Related to Over-the-Scope Clips: A MAUDE Database Analysis 超镜夹相关不良事件报告分析:MAUDE数据库分析
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2022.11.005
Daniyal Abbas , Mohamed Abdallah , Khalid Ahmed , Abubaker O. Abdalla , Nicholas McDonald , Shifa Umar , Brian J. Hanson , Mohammad Bilal

Background and Aims

Over-the-scope clips (OTSCs) have been increasingly used in the management of bleeding, perforations, fistulae, and anastomotic leaks in the gastrointestinal tract. However, since their Food and Drug Administration (FDA) approval in 2010, data on the adverse events of OTSC systems have been lacking. The aim of our study was to report and analyze adverse events and device failures associated with OTSC systems using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

Methods

We analyzed the FDA MAUDE database post-marketing surveillance data from January 2013 through May 2022 on the two OTSC systems available in the United States.

Results

Forty medical device reporting claims were found from January 2013 through May 2022. Adverse events were classified as device-related problems and patient-related adverse events. Forty device-related problems were reported, along with 20 device-related adverse events. Most device-related problems were reported in the Padlock defect closure system (n = 23), followed by the Padlock pro clip system (n = 8) and Ovesco OTSC system (n = 9). The most common device-related problem was related to the failure of OTSC deployment (n = 13), followed by material protrusion or extrusion (n = 7). The most common patient adverse events were perforation (n = 4), esophageal laceration (n = 4), bleeding (n = 3), and luminal stenosis (n = 3). All 4 patients required surgical management of the perforation. No deaths related to the use of OTSCs were reported.

Conclusion

Failure of OTSC deployment and perforation were the most common device-related problem and patient-related adverse event, respectively. As the use of OTSC systems continues to increase, it is important for endoscopists to be mindful of both the common and rare adverse events associated with OTSC use.

背景和目的内镜下夹(OTSCs)已越来越多地用于治疗胃肠道出血、穿孔、瘘管和吻合口瘘。然而,自2010年美国食品药品监督管理局(FDA)批准以来,一直缺乏关于OTSC系统不良事件的数据。我们研究的目的是使用美国食品药品监督管理局的制造商和用户设备体验(MAUDE)数据库报告和分析与OTSC系统相关的不良事件和设备故障。方法我们分析了2013年1月至2022年5月美国食品药品监督管理局MAUDE数据库关于美国两个OTSC系统的上市后监测数据。不良事件分为器械相关问题和患者相关不良事件。报告了40个器械相关问题,以及20个器械相关不良事件。大多数与设备相关的问题报告在Padlock缺陷闭合系统(n=23)中,其次是Padlock pro clip系统(n=8)和Ovesco OTSC系统(n=9)。最常见的设备相关问题与OTSC部署失败有关(n=13),其次是材料突出或挤压(n=7)。最常见的患者不良事件是穿孔(n=4)、食道撕裂伤(n=4,出血(n=3)和管腔狭窄(n=3,)。所有4名患者都需要对穿孔进行手术治疗。没有与OTSC使用相关的死亡报告。结论OTSC部署失败和穿孔分别是最常见的器械相关问题和患者相关不良事件。随着OTSC系统的使用不断增加,内镜医生必须注意与OTSC使用相关的常见和罕见不良事件。
{"title":"Analysis of Reported Adverse Events Related to Over-the-Scope Clips: A MAUDE Database Analysis","authors":"Daniyal Abbas ,&nbsp;Mohamed Abdallah ,&nbsp;Khalid Ahmed ,&nbsp;Abubaker O. Abdalla ,&nbsp;Nicholas McDonald ,&nbsp;Shifa Umar ,&nbsp;Brian J. Hanson ,&nbsp;Mohammad Bilal","doi":"10.1016/j.tige.2022.11.005","DOIUrl":"https://doi.org/10.1016/j.tige.2022.11.005","url":null,"abstract":"<div><h3>Background and Aims</h3><p>Over-the-scope clips (OTSCs) have been increasingly used in the management of bleeding, perforations, fistulae<span><span>, and anastomotic leaks in the </span>gastrointestinal tract. However, since their Food and Drug Administration (FDA) approval in 2010, data on the adverse events of OTSC systems have been lacking. The aim of our study was to report and analyze adverse events and device failures associated with OTSC systems using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.</span></p></div><div><h3>Methods</h3><p>We analyzed the FDA MAUDE database post-marketing surveillance data from January 2013 through May 2022 on the two OTSC systems available in the United States.</p></div><div><h3>Results</h3><p>Forty medical device reporting claims were found from January 2013 through May 2022. Adverse events were classified as device-related problems and patient-related adverse events. Forty device-related problems were reported, along with 20 device-related adverse events. Most device-related problems were reported in the Padlock defect closure system (n = 23), followed by the Padlock pro clip system (n = 8) and Ovesco OTSC system (n = 9). The most common device-related problem was related to the failure of OTSC deployment (n = 13), followed by material protrusion or extrusion (n = 7). The most common patient adverse events were perforation (n = 4), esophageal laceration (n = 4), bleeding (n = 3), and luminal stenosis (n = 3). All 4 patients required surgical management of the perforation. No deaths related to the use of OTSCs were reported.</p></div><div><h3>Conclusion</h3><p>Failure of OTSC deployment and perforation were the most common device-related problem and patient-related adverse event, respectively. As the use of OTSC systems continues to increase, it is important for endoscopists to be mindful of both the common and rare adverse events associated with OTSC use.</p></div>","PeriodicalId":36169,"journal":{"name":"Techniques and Innovations in Gastrointestinal Endoscopy","volume":"25 2","pages":"Pages 106-112"},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49750267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preface: Robotic Endoscopy–Current Engineering Developments, Clinical Applications, and Future Directions 前言:机器人内窥镜-目前的工程发展,临床应用和未来方向
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2022.10.007
Hung Leng Kaan , Philip Wai Yan Chiu
{"title":"Preface: Robotic Endoscopy–Current Engineering Developments, Clinical Applications, and Future Directions","authors":"Hung Leng Kaan ,&nbsp;Philip Wai Yan Chiu","doi":"10.1016/j.tige.2022.10.007","DOIUrl":"https://doi.org/10.1016/j.tige.2022.10.007","url":null,"abstract":"","PeriodicalId":36169,"journal":{"name":"Techniques and Innovations in Gastrointestinal Endoscopy","volume":"25 1","pages":"Page 1"},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49750268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adverse Events With Esophageal Stenting: A Call to Optimize Device and Endoscopic Placement 食管支架置入术的不良事件:呼吁优化设备和内镜放置
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2022.09.001
Devarshi R. Ardeshna , Farah S. Hussain , Gokulakrishnan Balasubramanian , Georgios I. Papachristou , Luis F. Lara , J. Royce Groce , Samuel Han , Peter J. Lee , Sajid Jalil , Alice Hinton , Somashekar G. Krishna

Background and Aims

Despite technological and procedural improvements, esophageal stents (ESs) have high rates of adverse events (AEs), including stent migration, recurrent stenosis, and chest pain. We sought to evaluate predictors and causes for early readmission following ES placement in hospitalized patients.

Methods

The National Readmission Database 2016-2018 was queried to identify hospitalized patients with an ICD-10-CM code for endoscopic ES placement. Primary outcome was early (≤ 30-day) readmission rate. Univariate and multivariable logistic regression models were used to evaluate predictors of early readmission.

Results

A total of 949 patients underwent index ES placement, and most (67%, n = 634) patients had benign indications. Overall, the most common indication was benign esophageal leak/fistula (n = 359), followed by malignant dysphagia from esophageal neoplasm (n = 252). The 30-day readmission rate was 26% (n = 251), with higher rates for benign (29%) compared with malignant (22%) indications (P = 0.09). An analysis of primary diagnosis for early readmissions revealed that stent-related AEs were higher in the benign than in the malignant group (42% vs 23%, respectively; P = 0.008). Multivariable analysis revealed that ES placement for esophageal leak/fistulas (OR = 1.98; 95% CI, 1.20-3.24; P = 0.022) was the only significant variable associated with early readmission.

Conclusion

In recent years, inpatient ESs have been placed predominantly in patients with benign conditions, with esophageal leak/fistula being the most common indication. Stent-related AEs account for a significant burden of readmissions, particularly when placed for benign conditions. There is a need for focused research to refine indications, optimize techniques, and improve stent technology.

背景和目的尽管技术和程序有所改进,但食管支架的不良事件发生率很高,包括支架移位、复发性狭窄和胸痛。我们试图评估住院患者植入ES后早期再次入院的预测因素和原因。方法查询2016-2018年国家阅读数据库,以确定内镜ES植入ICD-10-CM代码的住院患者。主要结果是早期(≤30天)再次入院率。单变量和多变量逻辑回归模型用于评估早期再入院的预测因素。结果共有949例患者接受了指数ES置入术,大多数(67%,n=634)患者有良性适应症。总体而言,最常见的适应症是良性食管漏/瘘(n=359),其次是食管肿瘤引起的恶性吞咽困难(n=252)。30天再入院率为26%(n=251),与恶性(22%)适应症相比,良性(29%)适应症的发生率更高(P=0.09)。对早期再入院的初步诊断分析显示,支架相关AE在良性组中高于恶性组(分别为42%和23%;P=0.008)。多变量分析显示,食管瘘/瘘的ES植入(OR=1.98;95%CI,1.20-3.24;P=0.022)是唯一与早期再次入院相关的显著变量。结论近年来,住院ESs主要用于良性疾病患者,其中食管瘘是最常见的指征。支架相关AE是再次入院的重要负担,尤其是在良性疾病中。需要进行重点研究,以完善适应症、优化技术和改进支架技术。
{"title":"Adverse Events With Esophageal Stenting: A Call to Optimize Device and Endoscopic Placement","authors":"Devarshi R. Ardeshna ,&nbsp;Farah S. Hussain ,&nbsp;Gokulakrishnan Balasubramanian ,&nbsp;Georgios I. Papachristou ,&nbsp;Luis F. Lara ,&nbsp;J. Royce Groce ,&nbsp;Samuel Han ,&nbsp;Peter J. Lee ,&nbsp;Sajid Jalil ,&nbsp;Alice Hinton ,&nbsp;Somashekar G. Krishna","doi":"10.1016/j.tige.2022.09.001","DOIUrl":"https://doi.org/10.1016/j.tige.2022.09.001","url":null,"abstract":"<div><h3>Background and Aims</h3><p>Despite technological and procedural improvements, esophageal stents<span> (ESs) have high rates of adverse events (AEs), including stent migration<span>, recurrent stenosis, and chest pain. We sought to evaluate predictors and causes for early readmission following ES placement in hospitalized patients.</span></span></p></div><div><h3>Methods</h3><p>The National Readmission Database 2016-2018 was queried to identify hospitalized patients with an ICD-10-CM code for endoscopic ES placement. Primary outcome was early (≤ 30-day) readmission rate. Univariate and multivariable logistic regression models were used to evaluate predictors of early readmission.</p></div><div><h3>Results</h3><p><span><span>A total of 949 patients underwent index ES placement, and most (67%, n = 634) patients had benign indications. Overall, the most common indication was benign esophageal leak/fistula (n = 359), followed by malignant dysphagia from </span>esophageal neoplasm (n = 252). The 30-day readmission rate was 26% (n = 251), with higher rates for benign (29%) compared with malignant (22%) indications (</span><em>P</em> = 0.09). An analysis of primary diagnosis for early readmissions revealed that stent-related AEs were higher in the benign than in the malignant group (42% vs 23%, respectively; <em>P</em> = 0.008). Multivariable analysis revealed that ES placement for esophageal leak/fistulas (OR = 1.98; 95% CI, 1.20-3.24; <em>P</em> = 0.022) was the only significant variable associated with early readmission.</p></div><div><h3>Conclusion</h3><p>In recent years, inpatient ESs have been placed predominantly in patients with benign conditions, with esophageal leak/fistula being the most common indication. Stent-related AEs account for a significant burden of readmissions, particularly when placed for benign conditions. There is a need for focused research to refine indications, optimize techniques, and improve stent technology.</p></div>","PeriodicalId":36169,"journal":{"name":"Techniques and Innovations in Gastrointestinal Endoscopy","volume":"25 1","pages":"Pages 11-20"},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49750514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Accuracy of Endoscopic Biopsies for Determining Tumor Grade in Pre-resection Evaluation of Esophageal Adenocarcinoma 食管腺癌切除术前内镜活检判断肿瘤分级的准确性
IF 2.4 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2023-01-01 DOI: 10.1016/j.tige.2023.06.001
Ravi S. Shah , Omar Alaber , Xuefeng Zhang , Abel Joseph , Siva Raja , Suneel Kamath , Ruishen Lyu , John J. Vargo , Sudish C. Murthy , Amitabh Chak , Amit Bhatt

Background and Aims

Endoscopic resection (ER) can be a curative treatment for early esophageal adenocarcinoma (EAC). Poor tumor differentiation is a histologic feature of noncurative ER and, when seen on preoperative biopsies, may lead to avoidance of endoscopic treatment. However, the accuracy of tumor grade on preoperative endoscopic biopsies remains unclear. The aim of this study was to determine the accuracy of tumor differentiation on endoscopic forceps biopsy compared with endoscopically or surgically resected tissue.

Methods

This retrospective cohort study from 2 tertiary referral centers compared tumor differentiation from preoperative biopsies with endoscopically or surgically resected EAC samples. Accuracy (%) of preoperative biopsy and agreement analyses (Gwet's AC2) were performed.

Results

In total, 346 EAC lesions (225 esophagectomies, 121 ERs) were included. The overall accuracy and reliability of EAC grade on preoperative biopsies compared with postoperative tissue from ER or esophagectomy was 74% (114/154), with a substantial agreement coefficient (Gwet's AC2 0.78 [0.72-0.85]; P < 0.001). The accuracy of ER was only 56%, with moderate agreement (Gwet's AC2 0.60 [0.46-0.73]; P < 0.001). Poorly differentiated tumors were downgraded to moderately differentiated in 19.6% (20/102) of tumors, and conversely, moderately differentiated tumors were upgraded to poorly differentiated in 22.7% (37/163) of tumors. For patients with T1a tumors, poorly differentiated tumors on preoperative biopsies were downgraded to moderately differentiated tumors in 40% (4/10) of cases after resection.

Conclusions

The accuracy of tumor grade of EAC on preprocedural biopsies is suboptimal and should not be depended upon solely to make decisions regarding endoscopic treatment.

背景与目的内镜下切除术(ER)是治疗早期食管腺癌(EAC)的有效方法。肿瘤分化差是非浸润性ER的一个组织学特征,当在术前活检中看到时,可能会导致避免内镜治疗。然而,术前内镜活检中肿瘤分级的准确性仍不清楚。本研究的目的是确定与内镜或手术切除的组织相比,内镜钳活检中肿瘤分化的准确性。方法这项来自2个三级转诊中心的回顾性队列研究比较了术前活检与内镜或手术切除的EAC样本的肿瘤分化。进行了术前活检和一致性分析(Gwet's AC2)的准确性(%)。结果共纳入346个EAC病变(225个食管切除术,121个ER)。与ER或食管切除术后组织相比,术前活检中EAC分级的总体准确性和可靠性为74%(114/154),具有显著的一致性系数(Gwet’s AC2 0.78[0.72-0.85];P<;0.001)。ER的准确性仅为56%,中度一致(Gwet's AC2 0.60[0.46-0.73];P<;0.001)。19.6%(20/102)的肿瘤中,低分化肿瘤降级为中分化,相反,22.7%(37/163)的肿瘤中将中分化肿瘤升级为低分化。对于T1a肿瘤患者,术前活检的低分化肿瘤在切除后40%(4/10)的病例中降级为中分化肿瘤。结论硬膜前活检中EAC肿瘤分级的准确性不理想,不应仅依赖于内镜治疗的决定。
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Techniques and Innovations in Gastrointestinal Endoscopy
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