UCSF With FDA In Robotic Colorectal Surgery Trial: da Vinci SP [2022]
The da Vinci SP Surgical Systems
So the daVinci is the robotic platform for a company called Intuitive. The daVinci has been around since 1999 and has had several generations of robots. Their most recent generation, which is ubiquitous around the US and increasingly being picked up around the world, is called the XI platform, and this is a multiport platform.
There are two types, one has four robotic arms. I can show a picture if you are interested. But it has four arms that go through four separate incisions, either in the chest for thoracic cases or in the abdomen for abdominal cases. And that’s the daVinci XI. The SP, which is another generation and is their newest robot, is called the SP because it’s a single port (surgery) robot (or robotic assisted technology).
And the idea behind that is that it’s only about 4 years old now. And the idea behind that is that instead of having four separate incisions on the abdomen or thorax, you just have this one arm. So you can see on the left hand side, this is the XI platform, which is the latest generation of the daVinci, and the even newer SP platform, which is a single arm, but that arm has a 2.5 cm robotic arm that when it goes inside it, it has a camera inbuilt.
All four of the arms that are available for the XI are available with a single port (surgery), but all come out of a single incision. So this is the intuitive SP platform. The intuitive SP platform was initially designed for. Head and neck surgeons use transoral surgery and it is FDA approved for head and neck surgery. It’s also approved for urology.
Although the uptake there has not been as widespread as it has been for the XI, it is not currently approved for any general surgery indications and it’s not currently approved for gynecology. And for this particular study, I wanted to use this platform to see if I could identify value and a role for it for colorectal surgery (hopefully minimally invasive surgery).
I have pretty significant experience with the XI or the multiplatform, or the multiple platform going back several years. But the SP platform is relatively new. And I realized immediately that there are some places in colorectal surgery where the SP platform makes absolute sense, like for example, trans anal procedures, but even in the abdomen, there are situations where it may make sense.
Such as rectopexy or taking down colostomies. And for that reason, I then worked with the FDA to try to come up with a study that they felt would be safe to do a trial for these patients (initial experience).
What Is The Current Standard Of Care For Colorectal Cancer Patients? And How Does Using the da Vinci SP Surgical Systems Fit In?
So for colon rectal cancer patients currently we basically we think of these patients in sort of 2 buckets, maybe 3 buckets, 1 is patients who have advanced disease stage 4, and those patients are primarily treated with chemotherapy. Then you have a sizable amount of patients who have stage 1, 2, or 3 stage cancer, so where the disease (characteristics) is local to the colon or rectum and has gone perhaps to the neighboring lymph nodes but has not gone to distant organs.
And in those situations, the primary modality of treatment for those patients is surgery. Now, to perform surgery (not minimally invasive surgery) means resection of that part of the colon rectum along with the lymph nodes for the most part. That can be done open with a big cut (more complex procedures and surgical area). It can be done laparoscopically (general laparoscopic surgery procedures), and it can also be done robotically.
And at least as far as we can tell from the early literature that has come out on robotic versus laparoscopy, there doesn’t appear to be any oncological downside to doing it either laparoscopically or robotically compared to open. And so, that’s currently the standard of care is a resection in appropriate patients. Now, outside of this particular indication, there are circumstances in which, for example, very early rectal cancer can be treated. With minimally invasive surgery, which is transanal, just resection of the bed of the tumor without doing a big abdominal operation (surgical area). And again, that’s the current standard of care for very early rectal cancers.
And in, in all of these circumstances, whether it’s transanal resection of very early rectal cancer, or the vast majority of colon, rectal cancers where surgery plays a role in stages 1 and 2 and 3. In all of these circumstances, the robot is appropriate and it gives all of the advantages of laparoscopy less incisions, less pain, faster recovery, but it has the additional advantage of being much more precise and, in complex patients, having a much lower conversion rate to open.
What Is The da Vinci SP Surgical Systems Clinical Trial Design?
Yeah, so the way we worked with the SP and the FDA to come up with the (using the da Vinci SP system or da Vinci surgical system) trial was that we recognized that this was a surgical trial with a completely new device.
We are not going to have a large number of patients to be able to have statistical validity on every complication or comparison, but we wanted to do a trial (using the da Vinci SP system or da Vinci surgical system)that showed that this particular robot was perhaps at least as safe as the current standard of multiport robotic surgery. And so what we did is we identified safety and quality events that occur around the time of surgery.
These are things like, how long does the operation take? The estimated blood loss, the. Oncology margins, fragmentation of the specimen, pain control, length of stay, and any perioperative complications like infections, blood clots, etc. And each of these events, complications, adverse events (serious complications), was assigned a score, which is 1 for each of them.
And then what was our plan to look at the scores of patients who underwent surgery with the SP platform and compare them during that same time period can be done contemporaneously with patients who underwent a similar procedure with the same CPT code using the multiport, standard XI platform. And so that’s how the study has been.
What Were the Inclusions and Exclusions Of The da Vinci SP Surgical Systems Trial? The Patient Characteristics?
The inclusions are pretty broad for the patient characteristics. Basically, it’s any adult, pregnant women can understand the study and give consent. The only exclusion criteria that we wanted to be careful about was that this is not appropriate for emergency cases.
It’s not appropriate for patients who have vitally metastatic disease or who have significant morbidities. So asa class for patients, for example and widely metastatic disease patients. But outside of that, the inclusion criteria, quite broad. Patients are not excluded if they have had prior surgeries.
They’re not excluded if, as long as they meet the appropriate criteria for robotic surgery, they would be candidates for an SP (da Vinci SP or da Vinci surgical system) trial study as well.
Please Highlight The Key Data Points Of The da Vinci SP
So the main things we are looking at, because this is an initial investigational device exemption study, are safety and quality events. And so we want to make sure that this particular use of this platform doesn’t result in a longer time, more blood laws, more conversions to laparoscopic or open.
And we want to make sure that the quality of the spens in the operation itself is appropriate. And then the patients recover well. So the data points cover all of these first safety and quality metrics, and those are our primary data points and our primary (patient) outcomes. And then subsequently, we also intend to discuss with patients surgical recovery (surgical outcomes), quality of life, as well as body image issues because we are finding that the use of just the single (one) incision compared to multiple incisions are things that patients are looking at (in their initial experience) and finding value.
This is an ongoing trial (da Vinci SP or da Vinci surgical system). We have recruited with the FDA for the IDE study, which allows only 25 patients. And so we have approval for 25 patients.
Currently. We have undergone surgery on six patients. So far, all of the patients have done extremely well with no major problems in any of the patients so far. And we had of the 2 patients who had postoperative events, 1 had a blood clot, and the second had pain that was outside the 90th percentile.
Both of these were examined very closely and did not feel to be related to the study itself just from the underlying pathology as well as from home comorbidities that the patient had going into the operation.
What Was The Primary Endpoint?
So after we look at the safety and quality events related to this particular cohort of patients, we are actually also in the process of comparing the same cohort with patients who wonder when standard platform surgery, so for the first part of our study, we included segmental ktom, which is right, colectomies.
We did five right colectomies with the SP, and we are comparing them with. All of our robotic right colectomy done in the last 2 years with this XI platform. And we identified 25 patients who had undergone that. And we are comparing the safety and quality events between both of those groups as a way to understand what the upsides and downsides are of the SP compared to the XI platform.
Were There Any Statistically Significant Outcomes Of The da Vinci SP?
Yeah, it’s a good question. The study itself is quite small compared to the phase 1 trial (da Vinci SP system), so it’s difficult to identify statistically significant (surgical) outcomes that are deferred.
What we have found is that our event rate is 2 out of 5, or 2 events out of every 5 patients. In the case of the SP right colectomies, and in examining our 25 patients, we identified 14 events that had occurred in those patients. And again, these events are not all safe, and some of them are quality events.
And about 9 of those 14 were just that the length of the operation was about the 90th percentile for laparoscopic and robotic cases. So it’s not that they were particularly concerning events, but we identified 14 patients in the traditional, with 14 events in the traditional versus 2 events in the new arm.
So we don’t think that this is statistically significant, which should be very difficult to show in this kind of study. But at least descriptively and anecdotally, there doesn’t appear to be a downside to using the SP platform in colectomies.
Your Journey To Study Colorectal Cancer
I went to medical school in India, and I came to the US immediately after that. As a graduate student, I was very interested in both cancer and surgery coming here. I had great mentors when I was a grad student who introduced me, transplant surgeons at Bohu introduced me to surgeons over there, and I really enjoyed being in the operating room. And then I did my residency in New York at Cornell. And again, I particularly enjoyed taking care of colorectal cancer patients, partly because it’s the kind of cancer that occurs in both young and old patients, men and women alike.
On the one hand, without any sort of environmental risk factors or lifestyle risk factors that have contributed to the cancer. So it’s completely out of the blue, mostly related to genetics, that patients get this cancer and even. On the one hand, it’s a devastating cancer, but on the other hand, it is one of the cancers that we can do something about most of the time. We have pretty good systemic chemotherapy for colorectal cancer and surgery (minimally invasive surgery) in patients who don’t have metastatic diseases. It is often successful in preventing recurrence and pausing cure. I really felt I thought that I could have a big impact on patients with colorectal cancer. And so that’s the reason for choosing this specialty.
Final Thoughts On The da Vinci SP (System) Trial
I would like to extend my gratitude. I work with amazing oncologists myself and I think it takes special doctors to take care of cancer patients, and oncologists are up there because of the challenges that I inherit from taking care of patients who often have metastatic disease or have disease (characteristics) that’s incurable and they often have
They have a course that is unpredictable and unclear, and it’s both emotionally traumatizing for the patients and the doctors taking care of them. So first of all, thank you. Second, this is an ongoing trial (da Vinci SP system), and so if you do have any patients, especially if you think of patients who would be appropriate for a transanal operation or an operation where you think this might be helpful, please feel free to reach out for the da Vinci SP (or da Vinci surgical system) trial.
Ankit Sarin, M.D., MHA, FACS, FASCRS – About The Author, Credentials, and Affiliations
Ankit Sarin, M.D., MHA is a colorectal surgeon who specializes in the surgery (and minimally invasive surgery) of the colon, rectum, anus, and associated gastrointestinal system. The American Board of Surgery and the American Board of Colon and Rectal Surgery have both certified Dr. Sarin. His primary surgical practice is located at the UCSF Helen Diller Family Comprehensive Cancer Care Center at UCSF Mt. Zion; however, he also performs operations at the UCSF medical center Moffitt-Long Hospital.
Dr. Sarin obtained his M.D. from Kasturba Medical College in Manipal, India, with honors. He then pursued a Master’s degree in health administration at Washington University in St. Louis, where he gained academic distinction. In New York City, he finished his residency in general surgery at New York Presbyterian Hospital / Weill Cornell Medical Center and Memorial Sloan Kettering Cancer Center.
Dr. Sarin spent a year at the University of California – San Francisco seeking a minimally invasive surgery fellowship in order to train in advanced laparoscopy after completing his residency. A second fellowship in colon and rectal surgery followed at Barnes Jewish Hospital / Washington University in St. Louis, Missouri. During medical school and training, he obtained a number of academic prizes.