Bob Underwood, MD (Host): An endoscopy is an invasive procedure that requires general anesthesia. Some risks include bleeding, perforation, adverse reaction to sedation, and infection. But in December of 2023, the gastroenterology

team at Children's Health introduced a new endoscopy procedure called unsedated transnasal endoscopy, or TNE. This new procedure doesn't require anesthesia, reducing risks, and is more cost effective for patient families. This is Pediatric Insights, Advances in Innovations with Children's Health, where we explore the latest in pediatric care and research. I'm your host, Dr. Bob Underwood. Today, Jacobo Santolaya, Pediatric Gastroenterologist at Children's Health and Assistant Professor at UT Southwestern, will talk to us about innovations of TNE and its benefits. Dr. Santolaya, welcome to the podcast.

Jacobo Santolaya, MD: Hey, Dr. Underwood, pleasure to be here. Thank you so much for having me.

Host: Absolutely. It's wonderful to have you on. And so can you share more about what unsedated transnasal endoscopy is and what diagnostic capabilities it offers for pediatric patients?

Jacobo Santolaya, MD: Yeah, absolutely. So this is a wonderful technology that we're really happy to be bringing to Children's Health here in Dallas. And, one that it's actually been around for several years, but, more recently, sort of now with this new model out of the EvoEndo system, as of February 2022 that had FDA approval, really kind of starting to see it spread across the country.

So what we're talking about here is essentially a technology that allows us to do what would normally be an endoscopy that has traditionally been done via the oral cavity. So just to kind of take it a step back, certain patients for different reasons may need to get an endoscopy to evaluate for concerns regarding abdominal pain, vomiting, other types of conditions.

And they normally would be put under anesthesia to get this procedure done where a scope goes through their mouth into the esophagus, which is the swallowing tube that connects the mouth to the stomach, and then is able to enter the stomach and take pictures, take biopsies. You can even go into the small intestine for a portion of the bowel.

And, normally this would be done under anesthesia. What's great about the transnasal endoscopy program is that we actually can do essentially the same capabilities, but without the requirement of anesthesia, which in some cases can be problematic for patients who've had issues with anesthesia in the past, or because of medical issues that they currently have, puts them at a higher risk for anesthesia.

So essentially what we're doing is instead of going through the mouth, we're actually taking an ultra slim scope. It's about 3.5 millimeters in diameter. So we're talking about kind of like the diameter of a Bucatini pasta. So very thin and then it has channels for us to sort of put through so we can get biopsies if we need.

And we're able to go through the nose while the patient's awake, enter into the esophagus, take pictures, go into the stomach and go from there. So really it gives us all the capabilities, but we're able to do this in the right patient, in unsedated fashion. So again, eliminating some of the potential complications from anesthesia.

Host: Yeah, I think some people don't realize how small this technology has actually gotten, which is one of the things that allows us to do stuff like this. So let's talk about you and the rest of the team of experts involved in introducing the procedure here. So is Children's Health the first pediatric hospital in Texas offering the procedure and are there any certifications or anything like that, that you had to earn in order to do these services?

Jacobo Santolaya, MD: So, yes, to your first question, Dr. Underwood, yeah, absolutely. So, we are the first pediatric children's hospital to officially have rolled this out and done it on a pediatric patient. I kind of briefly alluded that this isn't necessarily technology that hasn't been done in other sites before.

So, I think even in 2019, there were a couple pediatric centers across the country that were starting to roll this out. But again, the most recent system we have is, pretty new. But there are multiple centers across the country, but we happen to be the first in Texas, which again, we're very proud of.

Now, as far as certifications go, because it's a new technology, it's not something, that normally you would go through sort of a, very formal, training process like we would do for our regular endoscopies, which is something we generally do during our fellowship training in GI. but, it's something that, with practice that we have on several mannequins and the EvoEndo folks who are the company that helps us with these procedures and provides these really cool, slim gastroscopes, has multiple sort of training opportunities. So I personally, spent some time in Philadelphia, at the Children's Hospital there and worked with some of my colleagues there who also do this procedure.

So that's kind of how we rolled it out. And then since then, we're very happy to say that since December we have had several cases and all of them have been successfully completed, and we're hoping to roll this out over the future months and years.

Host: That's phenomenal and just a wonderful benefit for the patients that are going to need it. Speaking of which, are the conditions or diseases where TNE is used, you know, are there unique insights that you can get on these particular conditions by using this procedure?

Jacobo Santolaya, MD: Right now, to be completely transparent, we're focusing on a specific population, who have a condition called eosinophilic esophagitis. Now, this is the condition that is an inflammatory process occurring in the esophagus, secondary to a type of cell called the eosinophils, which we associate with kind of an allergy type cell.

So certain, food types or certain environmental triggers can lead to this accumulation of these eosinophils in the esophagus that leads to inflammation, and then can lead to some of these symptoms that I mentioned previously of, vomiting, abdominal pain, trouble swallowing or dysphagia. And this particular group of patients, once diagnosed, really do need frequent endoscopies because based on the treatment plans that we have for them, whether that be eliminating certain foods from the diet or starting certain therapies, we really need to know usually every eight to 12 weeks whether our treatment plan is working. And so that requires these patients to undergo another endoscopy. So you can imagine, after diagnosis in a single year, depending on, when you start the clock, you know, patients may have three or four of these endoscopies requiring anesthesia in a year.

And so by eliminating the need for anesthesia, this is for certain patients, can be a really great option. And it allows us again to still do the same type of screening. So we're able to get the pictures to see what does the esophagus look like. We're able to get those biopsies so we can actually measure the overall number of eosinophils in the tissue, and really, gives us all the information we need to know if we're making progress or if changes need to be made to the therapy plans.

So we are really focusing particularly on patients with eosinophilic esophagitis and partly also because right now, we're really kind of focusing on the stomach and predominantly the esophagus. But the system we have, and I think in the future something we're considering, could very well also evaluate for findings in the small intestine as well.

But for the sake of what we're trying to accomplish, which is again, is focusing on EOE which is eosinophic esophagitis and patients who require the sort of frequent endoscopies, that's the target population as of now at Children's.

Host: Oh, that's awesome. And so we kind of talked about the disease. Now let's talk about who's a good candidate for this procedure. What stage in a child's care would you use TNE?

Jacobo Santolaya, MD: I would generally recommend that the first time a patient undergoes an endoscopy for an evaluation of whatever the situation may be, that a traditional endoscopy or EGD as we call them, esophagogastroduodenoscopy via the oral route and anesthesia is probably a good place to start because you really can get further into the bowel and take your time. And, we can get the initial diagnosis. I would say the ideal candidate is someone who is probably, you know, nine to 10 years old or older. The reason being that you kind of want a certain level of maturity in the patient to be able to sort of tolerate the procedure, which we'll talk about, but it's certainly a very successful and tolerable procedure.

But you kind of have to understand that you want a patient who can understand what we're going to be doing, while we're know, talking them through it as well. So I would say an adolescent or, at least a nine to 10 year old patient and older who has already a pre-diagnosis of EOE or some sort of condition involving the esophagus or stomach.

Those would be the ones that I would say would be the ideal candidates, to sort of undergo this procedure. And it's really more, again, for the surveillance piece. Of course, we can use it as a diagnostic method as well, but I would say right now we'd focus on patients who already have a diagnosis and now we're sort of following them through with a surveillance type of screening.

Host: So, all right. Clinical costs and benefits. What are they for this new procedure?

Jacobo Santolaya, MD: I think in terms of clinically, again, we're getting the images, we're getting the biopsies, we're getting the information we need, so I don't think there's any sort of detriment, in terms of the clinical piece of using this procedure, for, again, the right population. In terms of some other, costs and benefits you know, I'd say, in general, because there is no anesthesia involvement, you're again, reducing partly some of the risk.

And so our consent process, even though, as far as the procedure itself, we review the same things in terms of risk of bleeding, like you mentioned, perforations, hematomas, etc. In general, we're not really dealing with any of the anesthesia types of side effects, which is great because we're not placing an IV, we're not doing any anesthesia, but also our scopes are single use.

And so this means that once we used it once, they're disposed of. And so we don't have the same potential risk for cross contamination when these normal endoscopes are cleaned, you know, and disinfected. So theoretically, and I think in terms of the research out there, we really see that there's a very low risk for infection with these types of scopes, and so, we're also helping with resistance to the multidrug resistant organisms that are being found across the country by not necessarily reusing scopes.

I'd say some of the other great benefits for the families and the patients is, really we're shortening their whole experience in the hospital. So just starting from fasting times. Generally speaking, you know, for a regular anesthesia related EGD or endoscopy, these are patients who've been, six to eight hours without eating or drinking anything.

That's fine first thing in the morning, but you can imagine in the afternoon that can be a bit trickier, particularly for some of our younger patients. So we're really asking our families to go two and maybe up to four hours prior to the procedure without eating anything, but two hours is actually sufficient.

So that's another perk for the family. And then again, in terms of the time that they're in and out, if you think about traditionally, patients would have to go in, they have to check in several hours before, they got to get the preparation, the pre-op, the consents from anesthesia, from GI, from, you know, et cetera, post procedure observation and recovery, not to mention the procedure itself, and then the recovery, I mean, we're talking about several hours that they're in the hospital. What we're targeting is trying to get families in and out within a couple hours from check in to discharge.

In my procedure time, really, we're shooting for 10 minutes or less. So, once we have the patient there, and we have them in the room and sat down and we discuss everything, from entrance into the nare to coming out, we're shooting and targeting less than 10 minutes, which is really what's been reported across the literature, as well as other endoscopists are doing this.

So, again, you're saving this time. These patients are able to go home within a couple hours of presenting to the hospital and return back to their regular activities. So we're not talking about any sort of post anesthesia hangover, quote unquote, or any sort of other side effects.

And I'm able to go back to school that same day, go back to sports, eat, all the other things. Cause it's a sedation free process.

Host: That's phenomenal. And talking about the fasting, I'm an adult, I know why you have to do it, and I still don't like it. So, kids, I'm sure, would be even more so. So, all right, say I'm a gastroenterologist, and I want to recommend this to my patients, patients family, what do I need to know? Is it generally well tolerated by patients? From the description you're, describing, I'm thinking yes, but what do I need to know as a gastroenterologist?

Jacobo Santolaya, MD: Absolutely, because you do want to make sure you have the right patient to start this. Because, it's not a completely sensation free process, right? There is a little bit of stimulation, but, I didn't really go into too much of the details, but to try to eliminate some of that, we, prep patients prior to the procedure with just a little bit of a numbing, topical, local, lidocaine.

So it essentially just numbs the back of the throat and the nasal passages. That's really all we really use for medicines. We also might use a little bit of what's called Afrin just to dilate a little bit the nasal passages and sort of allow that passage to, to be a little bit less swollen if they were already having any sort of, stuffy nose symptoms.

But that's it. And so, using that method, really, we're not talking about any other major medication. So that's something, you know, as a GI physician or someone referring to us, you just let them know that that would be the initial sort of medication. Now I'll tell you, it's a little bit uncomfortable getting that jelly, that lidocaine in the back of the nose, but not anything that's, not tolerable.

And, you know, in terms of the success rates for this procedure, there's over 300 articles on transnasal endoscopy now and in the literature. So this has been something people have been looking at for now several years. And they're quoting 94 to 98 percent success rate, some studies higher than 98%.

And so this is a very tolerable procedure. I would sort of pass on that, yes, there might be a little bit of discomfort going down, but again, the procedure is quick and, our success rate at least in the several cases we've done, have all been 100%. There are, course, some patients who may not be able to tolerate it and that's okay.

 At least they gave this procedure a try and could be something that are in the future, maybe at a later age or potentially not. But, in general, a very tolerable procedure. Again, it's a very thin scope. And so I would just pass on that, we do everything we can to make the process as easy as going.

Oh, and one other mention I should say, Dr. Underwood, that we actually provide all of our patients with VR goggles. so while they're getting this procedure done, having like a distraction video in place and they can pick whatever they like. And we found that that's really helpful as well, in terms of getting through the procedure.

And so, a very tolerable procedure for most patients.

Host: Yeah, that might make some kids look forward to the procedure with the VR goggles. I mean, you know, and considering the alternative or the more traditional way to do it, I mean, the benefits are clearly there. All right. So if a gastroenterologist, or another referring provider wants to learn more, how can they do this? Is there a clinic number that they can call or something like that?

Jacobo Santolaya, MD: Absolutely. Yeah. So our GI clinic number is probably the best place to start, in terms of reaching out to us. And, we can get you guys set up. That Dallas number is, 214-456-8000. And certainly they can put you in touch with people who can help make with that referral process. Generally speaking, again, we want patients who already kind of have a diagnosis.

It probably isn't the best procedure as of now, not to say that might not be the case in the future for, trying to find out a future dianosis. But if they have the right patient and based on what we discussed, Dr. Underwood, I totally think that them just reaching out to us is the first place to start.

We have some handouts and pamphlets that we hand out to families as well, but I would say reaching out to us and we can get in contact with anybody interested in terms of additional information and literature to provide their families and patients.

Host: Sure. You want to shoot us that phone number one more time?

Jacobo Santolaya, MD: Yeah, absolutely. So we also see patients in Plano as well, and some other satellites, but I would say starting with the Dallas clinic would probably be the best place to start. So that is, 214-456-8000. That is our general GI clinic, and then from there they can plug you into the schedulers, et cetera, and the referral folks to get your patient seen.

Host: That is awesome. Hey, as we wrap up, anything else that you want to share?

Jacobo Santolaya, MD: I think this is a really exciting technology that we're happy to be bringing to patients. We just rolled this out in December of 2023. So as we get more and more patients, I'm hoping to collect more testimonials. But, I can tell you, at least from our very first case, it was a very successful procedure.

The patient, the mother, were both very happy with the outcomes and results, and we were able to get the information we needed. And they are actually signed up to get their next transnasal endoscopy come March, for their follow up. So, we always love return patients. And so in this case, yes, I think it's a great option and something certainly to talk to about your doctor. And we're happy to discuss more with anyone who has additional questions or any concerns.

Host: Well, thank you. I think we all really learned a lot about the unsedated transnasal endoscopy and how this represents a significant leap forward in pediatric gastroenterology. So thanks for sharing your expertise and shedding light on this groundbreaking advancement in pediatric care.

Jacobo Santolaya, MD: Absolutely. My pleasure. Pleasure speaking with you.

Host: And thanks to our audience for listening to Pediatric Insights, Advances, and Innovations with Children's Health, where we explore the latest in pediatric care and research. You can find more information at childrens.com/gastroenterology. And if you found this podcast helpful, please rate, review, and share the episode, and please follow Children's Health on your social channels. I'm your host, Dr. Bob Underwood.