单独NOTES 与使用新的图像配准系统引导的 NOTES 用于纵隔导航的对比研究：猪模型研究。
Comparative study of NOTES alone versus NOTES guided by a new image registration system for navigation in the mediastinum: a study in a porcine model.
机构信息
Department of Gastroenterology, ICMDiM, Barcelona, Spain.
出版信息
Gastrointest Endosc. 2013 Jan;77(1):102-7. doi: 10.1016/j.gie.2012.09.008.
BACKGROUND
Natural orifice transluminal endoscopic surgery (NOTES) mediastinoscopy (MED) through the esophagus has proved to be feasible in the animal model. However, injury of the adjacent pleura and pneumothorax has been reported as a frequent adverse event when using a blind access.
OBJECTIVE
To assess the utility and safety of a CT-based image registration system (IRS) for navigation in the mediastinum.
DESIGN
Prospective, randomized, controlled trial in 30 Yorkshire pigs. Thirty-minute MEDs were performed: 15 MEDs were performed with IRS guidance (MED-IRS), and 15 MEDs were performed with a blind access.
SETTING
Animal research laboratory.
INTERVENTIONS
In both groups, the mediastinum was accessed through a 10-cm submucosal tunnel in the esophageal wall. Timed exploration was performed with identification of 8 mediastinal structures.
MAIN OUTCOME MEASUREMENTS
Technical feasibility, adverse events, and the number of mediastinal structures identified.
RESULTS
Thirty animals weighing 31.5 ± 3.5 kg were included in this study. MED was not possible in 2 animals in the "MED with blind access" group but was possible in all MEDs performed with IRS. The mean number of identified organs was slightly higher in "with IRS-MED" (6.13 ± 1.3) than with MED with blind access (4.7 ± 2.3; P = .066). Moreover, the right atrium and vena cava were identified in more cases with IRS-MED than in MED with blind access (13 vs 3 and 15 vs 11, P = .000 and P = .03, respectively). There were 3 (23%) adverse events with IRS-MED and 4 (27%) with "MED with blind access" (P = not significant), with pneumothorax being the most frequent (2 and 3, respectively).
LIMITATIONS
Nonsurvival animal study.
CONCLUSIONS
This study demonstrates that the IRS system appears feasible in natural orifice transluminal endoscopic surgery MED and suggests that IRS guidance might be useful for selected procedures.
背景
经自然腔道内镜外科（NOTES）经食管纵隔镜检查（MED）在动物模型中已被证明是可行的。然而，当使用盲目进入时，报告了相邻胸膜损伤和气胸作为频繁的不良事件。
目的
评估基于 CT 的图像配准系统（IRS）在纵隔导航中的效用和安全性。
设计
30 只约克夏猪的前瞻性、随机、对照试验。进行了 30 分钟的 MED：15 次 MED 采用 IRS 引导（MED-IRS），15 次 MED 采用盲目进入。
地点
动物研究实验室。
干预措施
在两组中，通过食管壁的 10cm 黏膜下隧道进入纵隔。进行定时探查，识别 8 个纵隔结构。
主要观察指标
技术可行性、不良事件和识别的纵隔结构数量。
结果
本研究共纳入 30 只体重 31.5±3.5kg 的动物。在“MED 伴盲目进入”组的 2 只动物中，MED 无法进行，但 IRS 引导的所有 MED 均可行。“IRS-MED”（6.13±1.3）比 MED 伴盲目进入（4.7±2.3；P=0.066）识别的器官数量略高。此外，IRS-MED 比 MED 伴盲目进入更能识别右心房和腔静脉（13 比 3 和 15 比 11，P=0.000 和 P=0.03）。IRS-MED 有 3 例（23%）不良事件，MED 伴盲目进入有 4 例（27%）（P=无显著性），最常见的是气胸（分别为 2 例和 3 例）。
局限性
非生存动物研究。
结论
本研究表明 IRS 系统在经自然腔道内镜外科 MED 中似乎是可行的，并表明 IRS 引导可能对某些手术有用。
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