Gotoda Takuji, Oda Ichiro, Tamakawa Katsunori, Ueda Hirohisa, Kobayashi Toshiaki, Kakizoe Tadao
Endoscopy Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Gastrointest Endosc. 2009 Jan;69(1):10-5. doi: 10.1016/j.gie.2008.03.1127. Epub 2008 Jul 2.
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.
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.
Prospective clinical trial at a single center.
National Cancer Center Hospital, Tokyo, Japan.
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 study.
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).
Unfavorable events and other intraoperative complications caused by the magnetic anchor or the magnetic force were recorded and evaluated. Two GI 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.
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 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.
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.
内镜黏膜下剥离术（ESD）治疗早期胃癌（EGC）在日本迅速普及。然而，该手术需要较高的操作技巧。为了通过单通道胃镜简化复杂的ESD手术（“单手手术法”），据报道，体外电磁铁控制的磁锚引导ESD（MAG-ESD）在猪模型中取得了成功。
这项前瞻性临床试验的目的是评估MAG-ESD治疗人体胃体部大EGC的可行性。
单中心前瞻性临床试验。
日本东京国立癌症中心医院。
2005年1月至2006年5月，纳入25例直径>20 mm、位于胃体部且组织学类型为肠型的EGC患者。排除有心脏起搏器、其他器官晚期恶性肿瘤、严重心肺疾病以及未控制的高血压和/或糖尿病患者。
与标准ESD类似，MAG-ESD手术在患者静脉注射咪达唑仑（3 - 5 mg）和喷他佐辛（15 mg）进行清醒镇静下进行。
记录并评估由磁锚或磁力引起的不良事件和其他术中并发症。两名胃肠内镜医师（T.G.，I.O.）根据“支持”和“不支持”两个标准评估磁锚是否有助于胃ESD。还评估整块切除率、并发症、总手术时间、出血、穿孔和复发率。总手术时间从内镜插入到拔出测量，包括回收一个或多个磁锚的时间。
所有肿瘤均整块切除，无穿孔或严重难以控制的出血。所有磁锚均安全回收。两名内镜医师评估MAG系统对23例患者有帮助。没有患者因长期磁场暴露出现生理和心理异常。中位随访20个月（15 - 32个月）期间，未观察到由磁锚不锈钢引起的延迟不良反应或过敏反应。
MAG-ESD是一种可行且安全的方法，通过适当的组织张力实现了良好的视野，便于EGC患者的胃ESD手术。该系统应小型化以适用于日常临床实践。
