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猪模型中内镜黏膜切除术与使用水刀混合刀进行内镜黏膜下剥离术治疗食管病变的随机对照研究。

Randomized controlled study of EMR versus endoscopic submucosal dissection with a water-jet hybrid-knife of esophageal lesions in a porcine model.

作者信息

Neuhaus Horst, Wirths Katja, Schenk Martin, Enderle Markus Dominik, Schumacher Brigitte

机构信息

Department of Gastroenterology, Evangelisches Krankenhaus Duesseldorf, Duesseldorf, Germany.

出版信息

Gastrointest Endosc. 2009 Jul;70(1):112-20. doi: 10.1016/j.gie.2008.10.042. Epub 2009 Mar 14.

Abstract

BACKGROUND

Endoscopic submucosal dissection (ESD) seems to be more effective than EMR for curative resection of GI mucosal neoplasia. However, ESD is technically difficult, hazardous, and time consuming. New technologies may overcome these drawbacks.

OBJECTIVE

Our purpose was to compare a new simplified ESD technique with conventional EMR.

DESIGN

Prospective, randomized, and controlled trial in anesthetized pigs.

METHODS

A total of 25 esophageal areas with a diameter of 20 mm were marked with coagulation points in 6 pigs under general anesthesia. These lesions were then randomized to either EMR by use of the cap technique or ESD. Submucosal injection of saline solution was used for both methods. ESD was performed with a hybrid-knife (ESDH), which allows cutting and coagulation as well as a needleless, tissue-selective hydrodissection through an axial water-jet channel with a preselected pressure by using a high-pressure water-jet system (ErbeJet 2). Intraoperative bleedings were treated with hemostatic forceps.

MAIN OUTCOME MEASUREMENTS

A comparison of the rates of complete resection of the lesions, the number and the size of resected specimens, the complication rate, and the procedural duration.

RESULTS

Thirteen lesions were randomized to EMR and 12 to ESDH. ESDH achieved complete resection significantly more frequently than EMR (10/12 vs 6/13; P = .05). All ESDH resections were performed as a single piece, whereas a mean (SD) of 2.5 +/- 0.9 resections were needed for EMR (P < .05). The mean (SD) areas of the specimen were 3.63 +/- 1.20 cm(2) in the ESDH group and 1.83 +/- 0.78 cm(2) in the EMR group (P < .0001). ESDH was performed with a larger amount of fluid for injection and hydrodissection compared with EMR (78.1 +/- 32.8 mL vs 20.9 +/- 7.6 mL; P < .001). The procedural duration was longer for ESDH than for EMR (28.2 +/- 11.9 minutes vs 12.2 +/- 4.9 minutes; P < .001). ESDH and EMR caused bleedings in 6 of 12 and 5 of 13 of the cases (P = .09), respectively. Hemostasis could be achieved in all cases. There was no perforation in either group.

LIMITATIONS

Resection of artificial non-neoplastic lesions, small numbers, an animal trial.

CONCLUSIONS

ESDH achieves complete resection of esophageal lesions significantly more frequently with a fewer number of specimens than EMR. ESDH is more time consuming, but the procedural duration seems to be shorter than conventional ESD because there is no need for exchange of devices for injection and cutting. The easy use of water-jet-assisted repeated injections of fluids may explain why ESDH was as safe as EMRC.

摘要

背景

对于胃肠道黏膜肿瘤的根治性切除,内镜黏膜下剥离术(ESD)似乎比内镜黏膜切除术(EMR)更有效。然而,ESD技术难度大、风险高且耗时。新技术可能会克服这些缺点。

目的

我们的目的是比较一种新的简化ESD技术与传统EMR。

设计

在麻醉猪身上进行的前瞻性、随机对照试验。

方法

在6头全身麻醉的猪身上,用凝固点标记25个直径为20mm的食管区域。然后将这些病变随机分为采用帽状技术的EMR组或ESD组。两种方法均采用黏膜下注射生理盐水。ESD使用混合刀(ESDH)进行,该刀可切割、凝固,并通过高压水射流系统(爱尔博jet 2)经轴向水射流通道以预选压力进行无针、组织选择性水分离。术中出血用止血钳处理。

主要观察指标

比较病变的完全切除率、切除标本的数量和大小、并发症发生率及手术时间。

结果

13个病变随机分为EMR组,12个病变随机分为ESDH组。ESDH组的完全切除率显著高于EMR组(10/12对6/13;P = 0.05)。所有ESDH切除均为整块切除,而EMR平均(标准差)需要2.5±0.9次切除(P < 0.05)。ESDH组标本的平均(标准差)面积为3.63±1.20cm²,EMR组为1.83±0.78cm²(P < 0.0001)。与EMR相比,ESDH注射和水分离所用液体量更多(78.1±32.8mL对20.9±7.6mL;P < 0.001)。ESDH的手术时间比EMR长(28.2±11.9分钟对12.2±4.9分钟;P < 0.001)。ESDH和EMR分别导致12例中的6例和13例中的5例出血(P = 0.09)。所有病例均能实现止血。两组均无穿孔发生。

局限性

切除人工非肿瘤性病变、样本量小、动物试验。

结论

与EMR相比,ESDH能更频繁地实现食管病变的完全切除,且标本数量更少。ESDH耗时更长,但手术时间似乎比传统ESD短,因为无需更换注射和切割器械。水射流辅助反复注射液体的简便性可能解释了为什么ESDH与EMR一样安全。

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