Barrigel® - The Future of Rectal Spacing - Neil Mariados
December 16, 2022
Neil Mariados, MD, Radiation Oncologist, Cancer Care of Western New York
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Neil Mariados: My name is Neil Mariados and I'm a combatant I guess in this war, in this space war. And I'll start off. This is, I think Barrigel is the future of rectal spacing and it's how control over placement is delivering optimized anatomical coverage with high patient safety. Placement gives you great coverage and also produces safety. I'm a radiation oncologist in Cancer Care of Western New York and these are my disclosures. I have prepared this chart over here that compares Barrigel and SpaceOAR, and I have omitted the BioProtect because it's not FDA approved. I went on the website to look at some information, couldn't get much and it hasn't published the results as yet. But what Barrigel shows is that it's a controllable, sculptable gel.
It's control placement and when you have time to deliver the bolus or the product, you can place it where you want and it's reversible. You have hyaluronidase that can, if you go into the rectal wall, that inadvertently obviously that you can reverse this. It's also a single step assembly and with SpaceOAR you have about 14 different steps. You have two different syringes and it's a polymerization of the product you can visualize Barrigel very well. SpaceOAR view, you can visualize that as well with the contrast. On transrectal ultrasound Barrigel is very, very clear. On CT scan you can visualize this as well. Our therapists who treat on the machine with Barrigel do not have any problems identifying Barrigel and on MRI it is also is highly visible. Here you can see there's the Barrigel on the left, there's SpaceOAR on the right.
Being privileged enough to be the principal investigators on both the Barrigel and the SpaceOAR, and being the author of the SpaceOAR trial, I was privileged to compare these different placements of SpaceOAR and Barrigel and what I saw more commonly with SpaceOAR was this off the starboard side looking picture that you see on the MRI here? But what I see on the Barrigel is consistent placement across the prostate rectal interface from the left lobe to the right lobe. It is sculptable because you don't have polymerization, you have your time to place it where you want. It is visible on the ultrasound as you can see in these slides here. And it's got this lifting power that once you put it in, it can truly just lift that side of the prostate. You can take your time and your pace. You can go as fast as you want or as slow as you want.
Here you've got to give credit to my colleague and friend Dan Wilkins, who was just proctored on placing Barrigel. He has no experience in brachytherapy or in the SpaceOAR, and what he did after being proctored with Barrigel about a few weeks later, he brought in seven of his patients that we have non-selected. These are all the patients that he did on an afternoon at the clinic under local anesthesia. And you can see he's got great spacing, excellent quality, excellent placement from the left side to the right side of the prostate on axial views. On sagittal views, you can see greater than 10 millimeter spacing throughout. Here's the next three patients. Again, these are unselected. His first go with Dan. So Dan, if you're out there, thank you very much.
There's some miscommunication, misperceptions that you cannot use hydro dissection and you actually can. In the trial we had seven patients that had hydro dissection and we tell the operators you can use hydro dissection if you want. But what happened was that most of the operators put this by the wayside as soon as they saw that they were really comfortable. And you can see the Barrigel and it's so hypoechoic compared to the hydro dissection and there were zero reports of embolism. That's another thing that is just going out there. But to tell you a little bit about the study, it is the only FDA approved hypofractionated trial with 60 gray in four weeks. We had 201 patients very similar to the SpaceOAR trial at 13 sites. And what we found was 98.5% achieved a 25% reduction in the rectum V90. I know a lot of you urologists here, what that means is that we're keeping the anterior rectal wall outside that green line to keep the dose down over there.
The Barrigel's on the right side and you can see that the anterior rectal wall is completely out, in good spacing, about 12.9 millimeters. Barrigel is safe. In the trial, there was a superior reduction in grade two GI toxicity. There were no severe adverse events. There were 5,000 cases done worldwide. But what you may not know, is that hyaluronic acid is also used in VOR, reflux in the pediatric population, and there's over 200,000 of those patients that have been treated with it as a bulking agent. So it's very safe. There's about 4 million cases performed on cosmetic surgery. So it's safe.
So I'll end off with this slide. In my experience here being privileged to try both these products out, I find that you need to know where you can place it. You need to know if you can view it on CT. And over here our therapists have had no problem seeing it on CT in the middle series there. And I think that this is an extremely good product and I think Barrigel is the future. Thank you very much.