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EMR中高频电设备参数设置会影响严重不良事件、完全切除率以及息肉复发吗?

导读:Gastroenterology七月刊上发表了一篇社论1,内容为西奈山伊坎医学院Iman Andalib教授等人对一项研究的评论,该研究2同样于前不久发表在Gastroenterology上,探讨EMR中高频电设备参数设置对息肉切除术后严重不良事件、完全切除率以及息肉复发的影响。

 

图源:https://www.gastrojournal.org/article/S0016-5085(20)30335-8/fulltext

Over the years, snare polypectomy has been performed with various types of electrosurgical settings being used for resection of larger polyps. The selection of which electrical current to use is at the endoscopist's discretion. Debate exists as to which type of electrosurgical settings are best for polyp resection. Some studies have suggested that polypectomy with a coagulation current may be associated with a greater risk of delayed bleeding whereas polypectomy with a blended cutting current may increase the risk of immediate bleeding. In this issue of Gastroenterology, Pohl et al attempt to answer these questions and report on the results of a multicenter randomized controlled single-blinded trial conducted across 18 medical centers between April 2013 and October 2017.

多年来,圈套器息肉切除术已使用各种类型的电外科设备实现了较大息肉的切除。内镜医师可自行选择电流。关于怎样设置高频电设备最适合于息肉切除术存在争议。一些研究表明,使用凝固电流的息肉切除术可能与更大的延迟出血风险相关,混合电流可能会增加立即出血的风险。在本期《胃肠病学》杂志中,Pohl等人试图回答这些问题并报告20134月至201710月之间在18个医疗中心进行的多中心随机对照单盲试验的结果。

A total of 928 patients undergoing endoscopic mucosal resection (EMR) of nonpedunculated colorectal polyps ≥20 mm were randomly assigned to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or pure coagulation current (Forced Coagulation) using the Erbe Vio 300D electrosurgical unit (ERBE USA Inc, Marietta, GA). The primary outcome of this study was the effect of the electrosurgical settings on severe adverse events and the secondary outcome was complete resection and recurrence at first surveillance colonoscopy. The authors defined severe adverse events as those requiring hospitalization, blood transfusion, colonoscopy, or surgery, or post polypectomy syndrome. They showed that there was no significant difference in the rate of severe adverse events (7.2% vs 7.9%; P = .762) between the Forced Coagulation and Endocut Q groups, respectively. Although there was no significant difference in perforation, fewer patients had a perforation event in the Forced Coagulation group than in the Endocut Q group (3 vs 6 patients; P = .320). However, a far larger study will be needed to truly evaluate the risk of perforation. Thus, endoscopists should be aware of this potential risk while performing hot snare polypectomy.

共纳入928例患有≥20mm无蒂结直肠息肉患者,准备接受内镜下黏膜切除术(EMR),患者被随机分配至使用金属夹闭合黏膜缺损或不使用金属夹闭合黏膜缺损(初始干预),然后使用Erbe Vio 300D电外科系统进行混合电流电凝(Endocut Q)或纯凝电流(Forced Coagulation)。这项研究的主要结局是电外科系统设置对严重不良事件的影响,次要结局是首次监测结肠镜完全切除和复发。作者将严重不良事件定义为需要住院、输血、结肠镜、或手术,或息肉切除术后综合征。研究显示,Forced Coagulation组和Endocut Q组之间的严重不良事件发生率并无显著差异(7.2 vs 7.9%;P= .762)。穿孔的发生率也无显著差异,但是Forced Coagulation组发生穿孔事件的患者少于Endocut Q组(3vs 6例;P=0.320)。但是,需要进行更大的研究才能真正评估穿孔的风险。因此,内镜医师在进行热圈套器息肉切除术时应意识到这种潜在风险。

图源:https://www.gastrojournal.org/article/S0016-5085(20)30335-8/fulltext

In addition, the study demonstrated visibly complete polyp removal in 95% of polyps in the Forced Coagulation group and 96% in the Endocut Q group. The resection sites were identified by the endoscopists in 91% of the patients during the surveillance colonoscopy. Furthermore, the rate of polyp recurrence did not differ significantly between the 2 groups (17.4% vs 16.5%; P = .762). Although the rate of macroscopically visible recurrence was not statistically significantly higher in the Forced Coagulation group, the histologic recurrence without visible polyp tissue was found slightly less frequently in the Forced Coagulation group than in the Endocut Q group (3.1% vs 6.0%; P = .07).

此外,该研究表明,Forced Coagulation组中95%的息肉和Endocut Q组中的96%的息肉完全清除。91%患者的切除部位在进行监测结肠镜检查中便得到了确定。此外,两组间息肉复发率无显著差异(17.4 vs 16.5%;P=0.762)。尽管Forced Coagulation组的肉眼可见的复发率较高,但并无统计学意义,而且其无可见息肉组织的组织学复发率略低于Endocut Q组低(3.1 vs 6.0%;P= .07)。

Finally, intraprocedural bleeding that required treatment such as a cauterizing method, and/or clips occurred less frequently during resection with Forced Coagulation than with Endocut Q (11 vs 17%; P = .006); however, this did not impact overall safety and efficacy. This is similar to the data from Van Gossum et al. Furthermore, Parra-Blanco et al showed that cutting current was associated with more immediate bleeding than delayed bleeding (66.1% vs 33.9%). These results could be due to several factors. First, the characteristics of these various currents can play a role; the coagulation current tends to heat-seal blood vessels, whereas pure cutting current tends to vaporize cells. Second, using different Forced Coagulation or Endocut Q settings could possibly yield different results. The following settings were used in the Pohl et al study: Forced Coagulation, effect 2 at 25 Watts; Endocut, effect 2, duration 1, interval 4. As the authors pointed out, these settings were chosen based on the endoscopists' clinical practice although testing was performed before the study using different settings on chicken meat with the final settings ultimately based on the observed thermal effect on the tissue. However, the manufacturer recommends Endocut settings of effect 3, duration 1, interval 6, which might have resulted in more immediate coagulation and less intraprocedural bleeding. A greater risk of intraprocedural bleeding can also impact the field of view during polypectomy, which can potentially increase the risk of other adverse events such as perforation or even greater risk of recurrence as it can partially block the endoscopist's field of view which can further lead to incomplete resection of all residual polyps. As mentioned, this study also showed risk of perforation may be slightly higher in the Endocut Q group. Hence, the selected current settings may be an important limitation of this study and future studies should take this important factor into consideration.

最后,与Endocut Q组相比,Forced Coagulation组需要电灼和/或金属夹治疗术中出血的发生率较低(11 vs 17%;P= .006)。但是,这并不影响总体安全性和有效性。这与Van Gossum等人的数据类似。此外,Parra-Blanco等人还显示,与延迟出血相比,切割电流与即刻出血的关联更大(66.1 vs 33.9%)。这些结果可能归因于几个因素。首先,不同电流的特性不同。凝固电流主要是热密封血管,而纯切电流则是使细胞汽化。其次,使用不同的Forced CoagulationEndocut Q设置可能会产生不同的结果。Pohl等人的研究中使用了以下设置:Forced Coagulation25Weffect 2Endocuteffect 2, duration 1, interval 4。正如作者所指出的那样,这些设置是根据内镜医师的临床实践选择的,尽管在研究之前对鸡肉进行了测试,最终设置最终取决于观察到的对组织的热效应。但是,制造商建议使用effect 3, duration 1, interval 6Endocut设置,这可能会实现更快速的凝血和更少的术中出血。术中出血风险较高也可能会影响息肉切除术的视野,这可能会增加其他不良事件(例如穿孔)的风险,甚至增加复发风险,因为它可能会部分遮挡内镜医师的视野,进而导致残留息肉的切除不完全。如前所述,该研究还显示Endocut Q组的穿孔风险可能会更高。因此,所选的当前设置可能是本研究的重要限制,未来的研究应考虑这一重要因素。

Given the recent advances in endoscopic technology, EMR using electrosurgery devices has become more common for polyps that are >20 mm. However, there are several types of electrosurgery units available, all with various electrical current settings. The selection of the devices and modes is usually at the endoscopist's discretion. Not many studies have compared different types of modes. This study by Pohl et al in this issue of Gastroenterology is important as it demonstrates that there is no substantial difference in safety and efficacy of polypectomy using either blended current or coagulation current. However, the debate over which current mode is best is likely to continue. Therefore, further studies will be needed to compare different current settings and their safety and efficacy during EMR polypectomy, potentially in larger studies to evaluate for possible small differences in recurrence and perforation rates.

鉴于内镜技术的最新进展,对于大于20mm的息肉,使用电外科设备的EMR已变得越来越普遍。但是,有几种类型的电外科设备可用,所有电外科设备都有不同的电流设置。设备和模式的选择通常由内镜医师决定。很少有研究比较不同类型的模式。Pohl等人在本期胃肠病学方面的这项研究非常重要,因为它表明使用混合电流或凝固电流对息肉切除术的安全性和疗效没有实质性差异。但是,关于哪种当前模式最好的争论可能会继续。因此,将需要进行进一步研究来比较EMR息肉切除术中不同的电流设置及其安全性和有效性,可能需要在较大的研究中评估复发率和穿孔率的细微差别。

高频电技术简介

高频电技术是指通过高频电源设备产生高频电流,再通过电刀对人体组织产生热效应。不同的热效应对组织起到不同的作用效果:当输出为正弦波时,形成电切效应,即高频电流在接触部位瞬间产生大量热量,使细胞破裂、汽化,表现为组织分离;输出为非正弦波时,会产生凝固效应,即高频电流在接触部位瞬间产生的热量较少,局部温度相对较低,使细胞失水干燥、蛋白质变性,表现为组织凝固。

高频电技术根据电流路径可分为单极技术和双极技术。双极器械因电流流经人体组织少、损伤小,较单极器械有更大的优势。

根据电压、功率、持续时间等不同的参数调节,电切与电凝可具有多种模式。以ERBE-VIO 300D为例,目前单极模式有自动电切、内镜电切(Endocut)、无血电切、强力电凝、柔和电凝、喷射电凝等。

Endocut分为Endocut IEndocut Q两种模式:Endocut I模式,电压较低,以电切为主,由此可以降低热损伤引起的副作用,常应用于对热敏感的组织切开,如内镜下逆行胰胆管造影术(ERCP)时的乳头切开;与I模式相比,Endocut Q模式电压较高,电凝成分相对较多,对于血管丰富的复杂手术,可以减少出血,保证视野清晰,但热损伤较大,通常应用于息肉切除术、内镜下黏膜切除术(EMR)、内镜黏膜下剥离术(ESD)、经口内镜下括约肌切开术(POEM)和黏膜下隧道法内镜切除术(STER)等操作。

来源:上海长海医院的柏愚副教授在中国消化道早癌防治中心联盟2019年度工作会议上对《消化内镜高频电技术专家共识》草案进行的详细解读

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