Prospective clinical trial of magnetic-anchor-guided endoscopic submucosal dissection for large early gastric cancer (with videos)
Prospective clinical trial of magnetic-anchor-guided endoscopic submucosal dissection for large early gastric cancer (with videos)
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DOI：
10.1016/j.gie.2008.03.1127
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发表时间：
2009-01-01
影响因子：
7.7
通讯作者：
Kakizoe, Tadao
中科院分区：
文献类型：
--
作者：
Gotoda, Takuji;Oda, Ichiro;Kakizoe, Tadao
背景：内镜黏膜下剥离术（ESD）治疗早期胃癌（EGC）在日本已迅速普及。然而，该程序需要高质量的技能。单工作通道胃镜辅助复杂ESD目的：本前瞻性临床试验的目的是评估磁锚引导ESD用于人体胃体部大EGC的可行性。设计：前瞻性临床试验，在一个单一的中心。设置：国立癌症中心医院，东京，日本。对象：从2005年1月至2006年5月，25例EGC直径> 20毫米，位于胃体，和膀胱型组织学入组。本研究排除了心脏起搏器、其他器官晚期恶性肿瘤、严重心脏和/或肺部疾病以及无法控制的高血压和/或糖尿病患者。干预措施：与标准ESD相似，MAG-ESD程序在清醒镇静下通过静脉注射咪达唑仑（3-5 mg）和喷他佐辛（15 mg）对患者进行。记录并评价磁性锚或磁力引起的不良事件和其他术中并发症。两名G1内镜医师（T.G.，（I. O.）根据2个标准评估磁性锚是否促进胃ESD：“支持”和“不支持”。“还评估了整块切除率、并发症、总手术时间、出血、穿孔和复发率。从插入到撤出的内窥镜，包括检索的磁性锚或anchors.Results的总手术时间进行了测量：所有肿瘤被整块切除，没有任何穿孔或严重的无法控制的出血。所有磁性锚钉均安全取出。2名内镜医师评估认为MAG系统对23名患者具有支持性。我的病人中没有一个因为长期暴露在磁场中而出现生理和精神异常。在中位随访20个月（15-32个月），既没有延迟的不良反应，也没有引起过敏的不锈钢的磁性锚observed.Conclusions：MAG-ESD是一种可行的和安全的方法，允许一个良好的可视化适当的组织张力和促进胃ESD患者EGC。该系统应小型化，使其适用于日常临床实践。（Gastrointest Endosc 2009;69：10-5.）
Background: The treatment of early gastric cancer (EGC) by endoscopic submucosal dissection (ESD) has been rapidly gaining popularity in Japan. However, the procedure needs a high quality of skill. To facilitate complicated ESD by using a single working-channel gastroscope ("one-hand surgery method"), the magnetic-anchor-guided ESD (MAG-ESD) controlled by an extracorporeal electromagnet was reported to be successful in a porcine model.Objectives: The purpose of this prospective clinical trial was to evaluate the feasibility of MAG-ESD for large EGC located on the gastric body in human beings.Design: Prospective clinical trial at a single center.Setting: National Cancer Center Hospital, Tokyo, Japan.Subjects: From January 2005 to May 2006, 25 patients with EGC > 20 mm in diameter, located in the gastric body, and intestinal-type histology were enrolled. Patients with a cardiac pacemaker, advanced malignancy in other organs, severe cardiac and/or pulmonary diseases, and uncontrolled hypertension and/or diabetes mellitus were excluded from this studyInterventions: Similar to a standard ESD, the MAG-ESD procedure was performed with the patient under conscious sedation by intravenous injection of midazolam (3-5 mg) and pentazocine (15 mg).Main Outcome Measurements: Unfavorable events and other intraoperative complications caused by the magnetic anchor or the magnetic force were recorded and evaluated. Two G1 endoscopists (T.G., I.O.) assessed whether the magnetic anchor facilitated gastric ESD according to 2 criteria: "supportive" and "not supportive." The en bloc resection rate, complications, total operation time, bleeding, perforation, and recurrence rate were also evaluated. The total operation time was measured from insertion to withdrawal of the endoscope, including the retrieving of the magnetic anchor or anchors.Results: All tumors were resected en bloc, without any perforations or severe uncontrollable bleeding. All magnetic anchors were safely retrieved. Two endoscopists assessed that the MAG system was Supportive in 23 patients. None of the patients I experienced physiologic and mental abnormalities as a result of long-term magnetic-field exposure. During a median follow-up of 20 months (15-32 months), neither delayed adverse effects nor allergies caused by the stainless steel of the magnetic anchor were observed.Conclusions: MAG-ESD is a feasible and safe method that allowed an excellent visualization by suitable tissue tension and facilitated gastric ESD in patients with EGC. The system should be miniaturized to make it applicable in daily clinical practice. (Gastrointest Endosc 2009;69:10-5.)