Prospective clinical trial of magnetic-anchor–guided endoscopic submucosal dissection for large early gastric cancer (with videos)

BackgroundThe 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.ObjectivesThe 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.DesignProspective clinical trial at a single center.SettingNational Cancer Center Hospital, Tokyo, Japan.SubjectsFrom 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.InterventionsSimilar 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 MeasurementsUnfavorable 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.ResultsAll 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.ConclusionsMAG-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.