FDA: Robotic Surgery For Breast, Cervical Cancer? What You Need To Know

FDA 发布乳腺癌,宫颈癌机械辅助手术情况须知

2019-03-04 08:00:00 Forbes


The U.S. Food and Drug Administration (FDA) has issued a warning about using robotically-assisted surgical devices for the removal of breast tissue (such as masectomies) for breast cancer, the removal of the uterus (hysterectomies) for cervical cancer, or the removal of any other cancer specific to women. That's because the FDA has determined that "the safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or prevention or treatment of cancer has not been established." The phrase "has not been established" is a polite way of saying, "we still don't really know what the bleep may happen." Robots in theory may sound cool and may allow surgeons to make smaller incisions when they operate. That's because robot arms could potentially slip into smaller holes in the body and combined with robot cameras allow surgeons to operate in smaller spaces. Such theoretical advantages have helped the use of robotic devices such as the da Vinci Surgical System grow in popularity. After all, it isn't too difficult to convince patients to get smaller incisions in their body than larger ones. A smaller incision, in theory, should be less painful with less risk of an infection and heal sooner. That's why such robotic surgery is considered a type of "minimally invasive surgery." There are some caveats, though. Minimally-invasive surgery with robots is not identical to traditional "open" surgery. Open surgery is when you make a large incision in the body. This allows the surgeon to directly see and touch different parts within the body. Doing so may not be as important for relatively simple surgeries such as removing a gallbladder when gallstones and not cancer are involved. But such actions may be quite important when you are trying to determine how much cancerous tissue is around. Naturally, when surgically trying to remove all the cancerous tissue, you don't want to leave any behind. The question then is: has robot technology and the accompanying cameras and sensors advanced far enough to replicate or replace the direct observation and contact of open surgery? The FDA is not so sure. The FDA announcement does cite the results of a clinical trial published this past November in the New England Journal of Medicine as cause for some concern. This trial randomly assigned over 600 patients with early stage cervical cancer to get either minimally invasive surgery (319 patients) or open surgery (312 patients). Of the 319 minimally invasive surgeries, 84.4% occurred through a laparoscope and 15.6% were robot-assisted. Results weren't as good for minimally invasive surgeries. Four-and-a-half years after the surgery, 96.5% of the patients who had gotten the open surgery were still alive with no sign of cancer, which was over 10% more than those who had gotten minimally invasive surgery (86.0%). A smaller percentage (91.2%) of the minimally invasive surgery group were free of cancer after three years than those in the open surgery group (97.1%) as well. The challenge is that robotic surgery is still relatively new. There just isn't enough data out there on its use for such cancer-related surgeries yet. It could be that results will get better as more surgeons get used to and experience using these robots. Moreover, not all surgeons are the same. After all, surgeons can use robots but are not robots. At least, they shouldn't be. Some may be better and some may be worse at traditional surgery. The same applies to using these robots. Plus, robot technology continues to evolve. The robots that will eventually take over the world as Skynet, replicate Justin Bieber, and make us their slaves haven't been created yet. Over the next several years, robot arms may get more nimble and sensitive. The cameras and sensors may get better and be able to provide better visualizations of what is inside the body. As Sarah Connor said in The Terminator 2: Judgement Day, "The future's not set. There's no fate but what we make for ourselves." Thus, while Barney Stinson got excited about robots versus wrestlers on the television series How I Met Your Mother, you may not want to use robots versus cancer just yet. The FDA is emphasizing that they have "not cleared or approved any robotically-assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival." Time and more studies are needed to determine the relative advantages and disadvantages. Meanwhile, technology and its use will continue to evolve. Therefore, as Barney says, "wait for, wait for it."
美国食品药品监督管理局(Food and Drug Administration)( FDA )已发出警告,建议使用机器人辅助手术设备来切除乳腺癌的乳房组织(如乳房切除术),切除宫颈癌的子宫(子宫切除术),或清除女性特有的任何其他癌症。这是因为 FDA 已经确定,“用于乳房切除手术或癌症预防或治疗的机器人辅助手术装置的安全性和有效性尚未确定。”“尚未确定”这个词是一种礼貌的表达方式,“我们仍然不知道会发生什么流血事件。” 理论上,机器人听起来很酷,可以让外科医生在手术时做较小的切口。这是因为机器人的手臂可能会滑入身体的小洞,并与机器人相机相结合,允许外科医生在较小的空间操作。这种理论上的优势帮助像达芬奇手术系统这样的机器人设备的使用越来越流行。毕竟,要说服病人在他们的身体上获得较小的切口并不太困难。从理论上讲,较小的切口应该较少疼痛,感染和愈合的风险较小。这就是为什么这种机器人手术被认为是一种“微创手术”。 不过也有一些警告。机器人微创手术与传统的“开放式”手术并不相同。开放手术是当你在身体上做一个大切口的时候.这使得外科医生可以直接看到和触摸身体的不同部分。这样做对于相对简单的手术来说可能并不重要,比如当涉及胆结石而不是癌症时切除胆囊。但是当你试图确定周围有多少癌变组织时,这样的行动可能是非常重要的。当然,当外科手术试图切除所有的癌细胞组织时,你不想留下任何痕迹。那么问题是:机器人技术以及伴随的摄像机和传感器是否已经足够先进,足以复制或取代开放手术的直接观察和接触? FDA 不太确定。FDA 的声明引用了去年11月发表在《新英格兰医学杂志》上的一项临床试验的结果,引起了一些关注。这项试验随机分配了600多名早期宫颈癌患者接受微创手术(319例)或开放手术(312例)。在319例微创手术中,84.4%是通过腹腔镜手术,15.6%是机器人辅助手术。 结果对微创手术效果不佳。手术四年半后,96.5%接受了开放手术的患者仍然活着,没有癌症迹象,比接受微创手术的患者(86.0%)多出10%以上。微创手术组3年后无肿瘤的比例(91.2%)也低于开放手术组(97.1%)。 挑战在于机器人手术仍然相对较新。目前还没有足够的数据显示这种癌症相关手术的用途。随着越来越多的外科医生习惯于使用这些机器人,结果可能会变得更好。而且,不是所有的外科医生都是一样的。毕竟,外科医生可以使用机器人,但不是机器人。至少,他们不应该。有些可能更好,有些可能在传统手术中更糟。使用这些机器人也是如此。 此外,机器人技术还在不断发展。这些机器人最终将以天网的形式占领世界,复制贾斯汀比伯,并使我们成为他们的奴隶还没有被创造出来。在接下来的几年里,机器人的手臂可能会变得更加敏捷和敏感。摄像机和传感器可能会变得更好,并且能够提供更好的身体内部的图像。正如 SarahConnor 在《终结者2:审判日》中所说,“未来尚未确定。”没有命运,只有我们为自己做的。” 因此,当 Barney Stinson 在电视连续剧《我如何遇见你的母亲》中对机器人和摔跤选手感到兴奋时,你也许还不想用机器人来对抗癌症。FDA 强调,他们“没有清除或批准任何基于癌症相关结果的机器人辅助手术设备,如整体生存、复发和无疾病生存。”需要时间和更多的研究来确定相对优势和劣势。同时,技术及其使用将继续发展。因此,正如巴尼所说,“等待,等待。”