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内镜黏膜下剥离术的最佳注射溶液:一项在猪模型中比较西方溶液的随机对照试验。

Optimal injection solution for endoscopic submucosal dissection: A randomized controlled trial of Western solutions in a porcine model.

机构信息

Internal Medicine Institute, Cleveland Clinic, Cleveland, USA.

Section of Surgical Endoscopy, Cleveland Clinic, Cleveland, USA.

出版信息

Dig Endosc. 2018 May;30(3):347-353. doi: 10.1111/den.12993. Epub 2017 Dec 27.

Abstract

BACKGROUND AND AIM

When carrying out endoscopic submucosal dissection (ESD), procedural safety increases with greater tissue elevation and efficiency increases with longer-lasting submucosal cushion. Fluids specifically developed for ESD in Asia are not commercially available in the West, leaving endoscopists to use a variety of injectable fluids off-label. To determine the optimal fluid available in the West, we compared commonly used fluids for Western ESD.

METHODS

All phases were carried out in an ex vivo porcine stomach model. Phase 1 compared tissue elevation and duration of submucosal cushions produced by various standard volumes of various injectable solutions used for ESD. The two best-performing solutions used off-label were tested head-to-head in ESD in Phase 2. Phase 3 compared the best solution from Phase 2 to Eleview , currently the only submucosal injection fluid approved in the USA. In Phases 2 and 3, five ESD were carried out with each solution. The solutions were randomized and the endoscopist blinded to the solution.

RESULTS

The best-performing solutions in Phase 1 were 0.4% hyaluronic acid, 6% hydroxyethyl starch (HES), and Eleview . Phase 2 compared 6% HES and hydroxypropyl methylcellulose (HPMC), showing that ESD with 6% HES was easier (P = 0.007), faster (P = 0.041) and required less injection volume (P = 0.003). In Phase 3, resection speed, ease of ESD and total volume per area resected were comparable between 6% HES and Eleview .

CONCLUSIONS

Of the submucosal injection fluids currently available in the West, Eleview and 6% HES are the best-performing solutions for ESD in a porcine model.

摘要

背景与目的

在进行内镜黏膜下剥离术(ESD)时,组织抬举高度越高,操作安全性越高;黏膜下抬举时间越长,操作效率越高。亚洲专门开发用于 ESD 的溶液在西方尚未商业化,这使得内镜医生只能使用各种非适应证的注射用溶液。为了确定西方可获得的最佳溶液,我们比较了常用于西方 ESD 的各种溶液。

方法

所有阶段均在离体猪胃模型中进行。第 1 阶段比较了各种用于 ESD 的标准体积的不同注射用溶液产生的组织抬举高度和黏膜下垫持续时间。第 2 阶段,将表现最好的两种非适应证溶液进行了头对头 ESD 比较。第 3 阶段将第 2 阶段的最佳溶液与 Eleview 进行了比较,Eleview 是目前唯一获得美国批准的黏膜下注射用溶液。在第 2 阶段和第 3 阶段,每种溶液均进行了 5 次 ESD。溶液随机分配,内镜医生对溶液不知情。

结果

第 1 阶段表现最好的溶液是 0.4%透明质酸、6%羟乙基淀粉(HES)和 Eleview。第 2 阶段比较了 6%HES 和羟丙基甲基纤维素(HPMC),结果显示,6%HES 进行 ESD 更容易(P=0.007)、更快(P=0.041),所需注射量更少(P=0.003)。第 3 阶段,6%HES 和 Eleview 的切除速度、ESD 难易程度和每单位面积切除的总容量相当。

结论

在西方目前可获得的黏膜下注射用溶液中,Eleview 和 6%HES 是猪模型中 ESD 表现最好的溶液。

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