Announcer:
0:00
Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts Hosted by cardiologist and top medical researcher, Dr Michael Koren.
Dr. Michael J. Koren:
0:11
Hello, I'm Dr Michael Koren, the executive editor of MedEvidence, and I have a really tremendous guest today and a friend, Ali Lankarani, who is a gastroenterologist and part of our research practice, and I'm going to gloat a little bit today, Ali. I'm going to gloat about the fact that I'm a cardiologist and you actually admitted before we got on air that gastroenterologists were learning from cardiologists
Dr. Ali Lankarani:
0:38
That is true. I stand by that, Mike.
Dr. Michael J. Koren:
0:41
Okay, and gastroenterologists are not always that willing to admit that.
Dr. Ali Lankarani:
0:46
That is very true and I hope, because of saying that, I would not be booted out from my society. But yes, we did learn many things from interventional cardiologists. I'm an advanced endoscopist so I do a lot of advanced procedures dealing with recurrence of structures, narrowings, tumors, those kind of things, and cross-pollination with all of the fields has been one of our ways of advancing, and a lot of things that we do do come from cardiology and also urology, believe it or not.
Dr. Michael J. Koren:
1:22
Interesting! Okay, we'll give our urological colleagues a little bit of love here. So tell the audience a little bit about yourself, how you got interested in gastroenterology and you started talking about being an advanced endoscopist, and I don't think most people really understand what that means. So go ahead and let us know about that.
Dr. Ali Lankarani:
1:40
Absolutely so. As you know, after finishing the training in medicine, people usually decide to go to two different routes. They can become an internist or become a surgeon. And, being a son of a surgeon, I decided to become an internist. Obviously, you want to go against your dad. So I became an internist and I really enjoyed just treating patients holistically with medications, not cutting them open. But after a while I realized that you cannot fix everything with molecules or pills.
Dr. Ali Lankarani:
2:16
So you might have- it is a good idea to have some sort of intervention in your toolbox and I found gastroenterology to be a very good mix of intervention and general internist kind of practice that we treat patients with medications; similar to cardiology - a little bit better. So I went to the field of gastroenterology, finished my training and at that point there was the introduction of some of the new technologies very new to the field of gastroenterology borrowed from radiology, and that was the advent of endoscopic ultrasound.
Dr. Ali Lankarani:
3:01
So, as our audience probably have seen, with ultrasound you can see through the walls of the organs, you can see on the other side what is happening. So we were doing the ultrasound from inside the GI tract; having a direct access to the pancreas, liver, gallbladder, bile ducts, all of those organs that if you want to target them from outside you have to go through other organs, and that was very attractive to me. So I decided to not finish;. after my general gastroenterology training was over, I did an advanced year and basically learned how to do endoscopic ultrasound and part of the training is also removing tumors, cancers in the GI tract, dealing with some recurrence of strictures, narrowing blockages, and basically doing procedures that used to require a surgical intervention, meaning opening up the body. Now we can do it endoscopically, through the natural orifice, through the mouth or rectum.
Dr. Michael J. Koren:
4:15
Nice.
Dr. Ali Lankarani:
4:16
We have even experimented with doing some surgical procedures that you might not be aware of. For example, there are some described cholecystectomies, or gallbladder removals, with no scars to the vagina, and you might find that interesting. Imagine if you're a model, if you're an actor. You don't want to have scars.
Dr. Michael J. Koren:
4:48
Oh, my goodness, wow, you gave me a lot to unpack there. But before I get there, you're not planning on doing heart catheterizations to the esophagus, are you?
Dr. Ali Lankarani:
4:57
No, but I do do echocardiogram because as I'm going in I have seen myxomas, which are tumors for the audience that can happen in the chambers of the heart and they only were found if you do an ultrasound. And, incidentally, I have found blood clots in the heart and directed the patient to see a cardiology because those can be very detrimental to their health and cause strokes and bad other consequences.
Dr. Michael J. Koren:
5:32
Yeah, just a little anecdote. So when I came to town some years ago I introduced transesophageal echo, so I've been doing endoscopy for a while also, so stealing something from the gastroenterologist.
Dr. Ali Lankarani:
5:42
Very good! Cheers to that, there we go.
Dr. Michael J. Koren:
5:44
But anyhow, the funny part about that was I got some feedback saying well, ultrasound is non-invasive. Why do you want to turn it into an invasive modality and put it into all these orifices?
Dr. Ali Lankarani:
5:57
So the enemy of ultrasound is air. Ultrasound waves, which are basically sound waves, transmit better through solid surfaces and the air will eliminate that. If you remember as a child two cups with a string attached that was, we didn't have walkie talkies. That was our walkie talkie.
Dr. Ali Lankarani:
6:20
Talking to my, sister and brother in the other room. So the same concept applies when you use the ultrasound waves for medical purposes. If you do ultrasound from outside the body, through the skin, there are a lot of air in your bowels. Therefore you do not get a good view of the bowels or pancreas or liver, but when you're inside you eliminate that.
Dr. Ali Lankarani:
6:48
The same concept that cardiologists use, because you have to deal with the air in the lungs. So when you do it through the esophagus you see better. But I don't need to tell you that.
Dr. Michael J. Koren:
6:58
We live it right, Beautiful. So we work together on research and tell the audience a little bit about how you got interested in clinical research, clinical trials, and maybe tease some of the things that you're doing now that might be of interest to the audience
Dr. Ali Lankarani:
7:13
efinitely. So, clinical research has been very important in my life, and the reason for that is that I went to the field of medicine to help people with their pain and suffering.
Dr. Ali Lankarani:
7:29
At the end of the day, I hope if somebody sees me after we are done, their quality of life is improved. So when that is your motto in life, you know that there are limitations to what we have currently, and nothing bothers me more than when I have to tell the patient that we have done whatever we have and we don't have anything else to offer you.
Dr. Ali Lankarani:
7:56
And I understand that we can only push the envelope by experimenting in a vert systematic manner, looking at the outcomes and see if what we think or the experts think that is helping, is it really in reality improving the quality of life, taking away the pain and suffering. So that's why I, very early in my years of education, I was drawn to this. Um, something that you might not know about me I had my first patent when I was a medical student.
Dr. Michael J. Koren:
8:35
Oh fabulous.
Dr. Ali Lankarani:
8:37
That was my dissertation we had I. I went to a seven-year medical school and we had to have a dissertation and I invented a machine called O-F-S-R. Optical Foot Shape Recognition Device. That came because I have flat feet and there was no objective way to measure that.
Dr. Ali Lankarani:
9:07
Being a son of an orthopod, I found that very disturbing, that they just look at you and they feel that this is the way, this is the diagnosis. So I invented something that can classify the degree of flatness of your feet to help with the treatment. So everything started from there and, after going through the residency and fellowship, I got involved with clinical trials. In private practice, which is my practice. Right now, it is harder to do research, but thanks to you and ENCORE, I was able to continue my passion and bring the cutting-edge technology to patients that are not necessarily in an academic institution, providing them with the latest and the best techniques available and, at the same time, being able to measure and see and show that hopefully, we improve their quality of life.
Dr. Michael J. Koren:
10:18
Sure, and just to clarify that for the audience, Dr. Lankarani and myself work in a group called the ENCORE Research Group, and ENCORE is an acronym for Encouraging Community Research and Education. And what that does is it brings cutting-edge research to community-based physicians and the patients of community-based physicians. So it's a wonderful thing. We've been working together in this partnership for five years and it's been fabulous.
Dr. Ali Lankarani:
10:46
Thanks to you and thanks for giving me the opportunity. I'm very excited, and that's why I'm here today to tell you about one of our newest studies.
Dr. Michael J. Koren:
10:56
Yeah, jump in. Yeah, I'd be really curious to know about it. So give us the scoop, as they say, or the poop because you're a GI guy. I like that.
Dr. Ali Lankarani:
11:05
No pun intended, right? So one of the frustrating situations that, as advanced endoscopists, I deal with are narrowings or blockages in the lumen of the GI tract. So, as you can imagine, the GI tract is just a plumbing system that starts from the mouth, go to the esophagus stomach, small intestine and large intestine. Now sometimes, for various reasons, you will have narrowings or blockages. That can happen anywhere, starting from esophagus going all the way to the anus. So the standard of care that we had was to dilate or stretch that area of narrowing and by mechanical force of expanding that lumen let's say a tube we would provide relief of some of the symptoms that patients are experiencing.
Dr. Ali Lankarani:
12:16
The problem with that approach is that most of the time when you just use a mechanical force to open up a narrowing, you will have some cuts or fissures or ulcerations, inflammation in that site as a result of mechanical expansion.
Dr. Ali Lankarani:
12:32
And whenever you have a cut or ulcer, we all know when you get a cut, the next thing is that scab forms and scar tissue builds up until the healing happens. That's scab formation from inside, which we call fibrosis, can can work against us when you're dealing with a narrowing, so mechanically you're expanding, but shortly after, the body is designed to heal and because of that fibrosis, the healing, the narrowing come back. So our colleagues in cardiology for the past 20 years and more recently our colleagues in urology, have found out if they combine a mechanical dilation with some sort of medication that can delay or postpone the fibrosis happening, we can improve the quality of life and keep the lumen open for a longer period of time. Interesting, you probably can talk to this more than I do, but I remember that for coronary disease first was just angioplasty, putting a balloon and just expanding.
Dr. Ali Lankarani:
13:57
And then we started having the coated balloons and then the stents, which are intra, like a straw that goes inside the blood vessel or a lumen, and those keep the lumen open and then coating it with these medications to prevent the narrowing from coming back. So that medication that is used for a long time in cardiology and urology and now we are borrowing that, it's called paclitaxel or PTX. It's very hard for me to pronounce that, so I will use PTX going forward.
Dr. Michael J. Koren:
14:36
In cardiology we've been saying paclitaxel for a while.
Dr. Ali Lankarani:
14:39
Right.
Dr. Michael J. Koren:
14:40
It kind of rolls off your tongue, but PTX works for me as well
Dr. Ali Lankarani:
14:56
So the hypothesis or the theory was that if we have a balloon that is coated with this medication at the time of the dilation, maybe we'll have better results and we can have a longer period of patency for the strictured area.
Dr. Michael J. Koren:
15:09
Ali, tell me a little bit more about these strictures and like what's a typical patient that might come in and why would they want to get involved in some of the research you're doing on strictures?
Dr. Ali Lankarani:
15:19
Sure, very good question, Mike. So one of the most common scenarios that we see are people coming and saying "when I'm swallowing, I feel the food gets hung up in my esophagus, doesn't go down. Some people say that they might have to have a sip of water, or sometimes they have induced vomiting because it doesn't want to go down, and usually, most commonly, those are because of the benign scar tissue formations in the esophagus what we call peptic strictures, or this can be related to reflux disease or other conditions. Obviously, people need to keep in mind that there are other causes that are not benign and if you ever have problem with swallowing, you definitely need to see a gastroenterologist to have endoscopy to check for esophageal cancer.
Dr. Michael J. Koren:
16:13
That is a really important point. So having difficulty swallowing is not a normal thing by any stretch of the imagination.
Dr. Ali Lankarani:
16:20
Absolutely not, and it is sad for me to admit, but our audience need to know that esophageal cancer is the fastest growing cancer in United States and it is directly related to GERD, or reflux, and one of the biggest causes for reflux is obesity and, as we know, there is a pandemic of obesity.
Dr. Michael J. Koren:
16:48
Now, how common is it to have difficulty swallowing that leads to a medical evaluation? 10%, population, 20?. What do you think?
Dr. Ali Lankarani:
16:56
I would say probably you have to look at different age groups, but it is probably around 10% to 15% of people around 60 or above will have some difficulty in swallowing and some of them are not related to cancer, but obviously we have to keep that in mind. So, going back to the benign structures, which is because of reflux, you're having a scar tissue forming in your esophagus, or food doesn't want to go down. First is once every year or whenever.
Dr. Ali Lankarani:
17:29
We are all you know busy, sometimes inhaling our food to just get to the kids to work and instead of being once a year, it becomes two times a year and more frequent. So in those situations a gastroenterologist generally just go with a flexible tube which is the diameter of my pinky nine millimeter from the mouth under sedation, so the individual is completely out. We go to the esophagus and evaluate the esophagus with a camera and a light source that is connected to our flexible scope and if we see that this is as a result of a benign, let's say structure, because of the reflux, at the same setting we use balloons that we inflate to different diameters to break those scar tissue bands and stretch the esophagus and that will alleviate their problem. And very commonly after the procedure I hear from the patient so I should be good forever and unfortunately that's not the case.
Dr. Michael J. Koren:
18:40
Forever is a very long time.
Dr. Ali Lankarani:
18:42
Exactly. And, as we know, in medicine usually there is nothing that lasts forever. So we know from research that 30 to 40% of the patients that have symptomatic improvement of their swallowing; they have a recurrence within one year. So 40% need another endoscopy, another sedation semi-invasive it's not surgery, but still invasive losing work and everything and have a dilation of their esophagus and they are good for another year or so. There are some situations - I call them my super healers - where this can happen even faster. I have had patients that I had to stretch their throat every two weeks or every four weeks. Yikes, in some situations we even have devices that we give to the patients and they do self-dilation. So this is a bougie. It's imagining a tube with a pointy tip. Have you ever seen, mike, people that swallow swords?
Dr. Michael J. Koren:
19:50
Yeah, yeah, yeah.
Dr. Ali Lankarani:
19:50
So it's basically the same thing, they extend their neck and they do a self-dilation of their esophagus. Oh my goodness. Now this talks to my age a little bit. It is less common nowadays.
Dr. Michael J. Koren:
20:04
Wow, yeah.
Dr. Ali Lankarani:
20:05
But this is what we had to do when we didn't have the expertise or knowing to look into other subspecialties and learning from them.
Dr. Ali Lankarani:
20:16
So now, with the invention of this balloon, which we are evaluating, the idea is that if we get the balloon coated with PTX and put it in the structure, PTX after the dilation will have a better local absorption because there is disruption of the lining of the esophagus so that area is open, blood vessels are exposed and the medication can penetrate easier to the lower layers, preventing those fibroblasts to make the scar tissue. And we can prolong this process.
Dr. Michael J. Koren:
20:56
And that drug you're using is Paclitaxel we talked a little bit about last session which is anti-proliferative, and PTX is the term we're using to make it simpler to say it but it seems to be effective at preventing the scarring from returning.
Dr. Ali Lankarani:
21:11
Definitely, and I am happy to have the report of the first 20 patients that prospectively dilated.
Dr. Michael J. Koren:
21:20
Is that something we can share publicly?
Dr. Ali Lankarani:
21:22
We can share this publicly it hasn't published yet.
Dr. Michael J. Koren:
21:26
You got to be a little careful about that. But if it is in the public domain, then we'll share it. But we typically have a footnote to these podcasts and we'll be able to do that.
Dr. Ali Lankarani:
21:34
Absolutely, so from the first 20 patients that have been enrolled in the study, we have learned that with only one dilation with a drug-coated balloon we get 30% improvement of the symptoms compared to the uncoated balloon or standard of care and if you repeat that for two times, we find a 73% improvement of symptoms.
Dr. Michael J. Koren:
22:04
Oh, wow.
Dr. Ali Lankarani:
22:04
That is very significant improvement. Usually in medicine you can tell me getting numbers like this are not that easy.
Dr. Michael J. Koren:
22:14
And it sounds like it's safer than swallowing a sword.
Dr. Ali Lankarani:
22:17
Definitely, definitely, less archaic.
Dr. Michael J. Koren:
22:21
Wow, that's fabulous. Well, that's really exciting. So congratulations on the work to date. These studies are still looking for folks still enrolling.
Dr. Ali Lankarani:
22:29
Absolutely. We are having two subsets of patients that we are looking to enroll in these studies. The one of them is just focusing on the esophagus and the other study focuses on the rest of the GI tract. So the scar tissue formations do not only happen in the esophagus, as you can imagine, small intestine and colon less common because they have a larger diameter but especially in situations that, let's say, somebody needed to have surgery, and at the anastomosis where the hookup of the two lumens are just because of the sewing and the foreign material that is used, the staples, any foreign material in the body can cause fibrosis and structure formation. In those folks we will see a good improvement as well.
Dr. Michael J. Koren:
23:24
So using these drugs is something that's brand new? You don't have anything on the market now for this purpose, or are there other products in the market?
Dr. Ali Lankarani:
23:32
This is the only available study.
Dr. Michael J. Koren:
23:35
But only in clinical trials. So there's nothing commercially available, right now?
Dr. Ali Lankarani:
23:39
No commercial.
Dr. Michael J. Koren:
23:41
And just so the audience understands, this is part of a clinical trial. So you would come in, you would get a full description of what's involved, you would sign an informed consent form and then, ultimately, if somebody like you felt you were an appropriate patient, then you can become part of this research.
Dr. Ali Lankarani:
23:58
Definitely, Yes.
Dr. Michael J. Koren:
23:59
You can't just walk in and do it. Just to be clear, Absolutely not.
Dr. Ali Lankarani:
24:04
This is a very systematic approach and we continue to watch the patients. Actually, the protocol for the study is very specific. There are some inclusion criteria, but if you pass that and you're a good candidate, you will get endoscopy at the index. And then after a month, and then three months and six months later we measure the diameter. We collect the symptom diary of the patients and make sure
Dr. Michael J. Koren:
24:36
So it's a commitment on the patients as well.
Dr. Ali Lankarani:
24:38
For five years commitment, yeah.
Dr. Michael J. Koren:
24:40
So I think it's important that we're not trying to sell a product here. This is a process by which medicine gets better. We will screen people and make sure that they're good candidates. If you see something that you don't like, that you think would compromise the safety of a participant, you'll say no, of course. And then, once they get involved, we need their commitment to stick with the program so that the data can ultimately make a decision about whether or not other physicians should be using this.
Dr. Ali Lankarani:
25:07
Absolutely correct, mike. This is like any other clinical trial. First of all, the participants should know that these are trials, so that's the way we learn if it is working or not, and obviously they will receive this as a part of the clinical trial, usually without any financial burden on them, because they're participating. But as a result of that, we collect their data in an anonymous manner. Nobody will know that you were part of the study, but those data will be extracted and calculated at the end to make sure that we are actually getting the effect that we are looking for.
Dr. Michael J. Koren:
25:48
Interesting. So in a crazy way we're talking about cardiologists and gastroenterologists before I can be a referring doc for the study. Because when I do a trans-esophageal echo sometimes I get resistance when I'm trying to pass the probe and, unlike you, I don't have a camera on that probe. It's pure ultrasound. So I can't see what's in the esophagus, just what's outside of the esophagus. So next time I run into an obstruction I'll give you a call and maybe we'll find somebody that can benefit from the work you're doing.
Dr. Ali Lankarani:
26:16
Absolutely! But we touched upon this. I want to again make sure that all of our audience know difficulty swallowing is not normal. It needs to be evaluated. Unfortunately, some situations are found by doing tests, but hopefully people can pay better attention to this fact that they should not have any trouble.
Dr. Michael J. Koren:
26:39
So let's build on that point, because I've learned through my association with you and your colleagues that there are other things that we can treat that can cause difficulty swallowing. And one of the things that I learned is that eosinophilic diseases can also cause problems with swallowing and that can happen in young people. I was surprised to learn that teenagers can have eosinophilic problems with their esophagus and maybe never get diagnosed properly. So maybe just touch base on that as we end our little time together.
Dr. Ali Lankarani:
27:06
Absolutely so. Any condition that causes ongoing inflammation in the esophagus; over time that inflammation translates to fibrosis and scar tissue forming and eventually trouble swallowing and narrowings. And one of the reasons for chronic inflammation in this lining of the esophagus are autoimmune related diseases. Autoimmune diseases are the diseases are derived from attack of your fighter cells in your body to your own organs. The fighter cells are designed to attack bacteria and cancer ce lls, but in some situations you have those fighter cells attacking your internal organs by mistake and one of those branches of fighter cells are called eosinophils. You can imagine that as different branch of army and navy that we have.
Dr. Ali Lankarani:
28:11
So eosinophils start attacking your esophagus and causing that ongoing inflammation in the esophagus and over time that can cause difficulty swallowing. And we see that very frequently in starting at a very early ages in children, as you mentioned.
Dr. Michael J. Koren:
28:27
Yeah, fascinating. So I think the take-home lesson is that if you have any kind of problem swallowing, get medical attention and then let gastroenterologists do their work, figure out what's going on and whether it's a eosinophilic problem with this infiltration of these cells or a stricture that you can identify or something more ominous, you're going to be there and figure it out for them. And in situations where we don't know how to best approach the problem, we have a research option to help us figure that out.
Dr. Ali Lankarani:
29:00
Absolutely. And the nice thing about being part of the research is that not only you will hopefully improve your own situation, your own pain and suffering, but also you're adding to the wealth of knowledge that will be used to help other people.
Dr. Michael J. Koren:
29:18
And so people don't get frightened. But sometimes it's a benign thing. It could just be reflux or something that's relatively easy to treat. It doesn't mean that you have some sort of death sentence when you have trouble swallowing, that you would want to avoid medical attention because of your concerns.
Dr. Ali Lankarani:
29:33
No, Majority of the diseases by far. I am not sure about exact numbers, but I would say probably 1 out of 10 or 15 are only conditions that might be related to cancer. Nine or 14 out of 10 or 15 are benign.
Dr. Michael J. Koren:
29:53
That's great. Thank you, Ali. That was fabulous information. Thank you for educating me. I thank you on behalf of the MedEvidence audience and we'll definitely have you back, and we want to hear more follow-up on some of the great work you're doing. Thank you, Mike.
Dr. Ali Lankarani:
30:05
I appreciate for giving me the opportunity. I will be happy to come back anytime you want Good deal.
Announcer:
30:11
Thanks for joining the MedEvidence podcast. To learn more, head over to MedEvidence. com or subscribe to our podcast on your favorite podcast platform.
