Maiss J, Dumser C, Zopf Y, Naegel A, Krauss N, Hochberger J, Matthes K, Hahn E G, Schwab D
Department of Medicine I, University of Erlangen-Nürnberg, Erlangen, Germany.
Endoscopy. 2006 Jun;38(6):575-80. doi: 10.1055/s-2006-925000.
Hemoclip therapy is a well-established procedure in the treatment of gastrointestinal bleeding. Although new products are provided periodically by the industry, comparative investigations are lacking. We compared two different hemoclip devices in an experimental setting, assessing them using objective hemostatic parameters.
We compared two disposable clip devices (Olympus HX-200L-135 (n = 40) vs. Wilson-Cook Tri-Clip (n = 40)) in an experimental setting using the compact Erlangen Active Simulator for Interventional Endoscopy (compactEASIE) training model equipped with an upper gastrointestinal-organ package for bleeding simulation. This was a randomized, prospective, controlled trial. Four investigators with different levels of endoscopic experience applied ten hemoclip devices of each type to the spurting vessels, the clips allocated using a randomized list for each investigator. The efficacy of hemostasis was determined by continuous measurement of the pressure within the afferent vessel before and after clip application and calculation of the relative reduction of vessel diameter by the clip device. The system pressure was recorded over the period from 1 minute before to 1 minute after clip application. A secondary end point was a subjective assessment of the whole clip application procedure by the endoscopist and the assisting nurse, using a visual analog scale (0 - 100, with 100 representing the best experience).
A total of 39/40 clips of each type were applied successfully. Both clip devices led to a significant increase in system pressure, representing significant relative reduction of vessel diameter (Olympus 5.4 +/- 7.5 %, p < 0.001; Cook 4.9 +/- 8.0 %, p < 0.001). Overall, there was no significant difference between the two devices ( P = 0.756). However, the investigator with the least experience in endoscopy (< 100 procedures) produced significantly inferior results compared with the other three investigators, who had performed between 2000 and 6000 procedures each ( P < 0.05). We found no evidence of a learning curve from the intra-observer results. The devices received good, but not significantly different, overall ratings by the endoscopists (Olympus 69 +/- 24 vs. Wilson-Cook 65 +/- 16) and by the assisting nurses (Olympus 77 +/- 9 vs. Wilson-Cook 70 +/- 22).
Using an established cadaveric training model, no significant difference was found between the two types of hemoclip devices with respect to their "hemostatic efficacy". However, the experience of the endoscopist appears to play a major role in successful clip application. The use of a feedback mechanism in emergency endoscopy training, using continuous intravessel pressure monitoring, may substantially enhance the efficacy of training, resulting in a similar improvement in clinical results.
金属夹疗法是治疗胃肠道出血的一种成熟方法。尽管行业定期推出新产品，但缺乏对比研究。我们在实验环境中比较了两种不同的金属夹装置，并使用客观止血参数对其进行评估。
我们在实验环境中，使用配备用于出血模拟的上消化道器官包的紧凑型埃尔朗根介入内镜主动模拟器（compactEASIE）训练模型，比较了两种一次性夹装置（奥林巴斯HX - 200L - 135（n = 40）与威尔逊 - 库克三夹钳（n = 40））。这是一项随机、前瞻性、对照试验。四名具有不同内镜经验水平的研究者将每种类型的十个金属夹装置应用于喷射血管，使用随机列表为每位研究者分配夹子。通过连续测量夹闭前后传入血管内的压力以及计算夹装置使血管直径的相对减小来确定止血效果。在夹闭前1分钟至夹闭后1分钟期间记录系统压力。次要终点是内镜医师和协助护士使用视觉模拟量表（0 - 100，100表示最佳体验）对整个夹闭应用过程进行主观评估。
每种类型的40个夹子中，各有39个成功应用。两种夹装置均导致系统压力显著升高，表明血管直径显著相对减小（奥林巴斯5.4 +/- 7.5%，p < 0.001；库克4.9 +/- 8.0%，p < 0.001）。总体而言，两种装置之间无显著差异（P = 0.756）。然而，内镜经验最少（< 100例手术）的研究者与其他三位研究者（每人进行了2000至6000例手术）相比，结果明显较差（P < 0.05）。我们从观察者内结果中未发现学习曲线的证据。内镜医师（奥林巴斯69 +/- 24 vs. 威尔逊 - 库克65 +/- 16）和协助护士（奥林巴斯77 +/- 9 vs. 威尔逊 - 库克70 +/- 22）对这些装置的总体评价良好，但无显著差异。
使用既定的尸体训练模型，两种类型的金属夹装置在“止血效果”方面未发现显著差异。然而，内镜医师的经验似乎在成功应用夹子方面起主要作用。在急诊内镜训练中使用反馈机制，通过连续监测血管内压力，可能会显著提高训练效果，从而使临床结果得到类似改善。
