[Music] foreign [Music] thank you for taking time from your busy day to watch this special presentation from the El Paso County Medical Society I'm Dr Joel Hendricks president of the El Paso County Medical Society and it is my hope that you will find our program of great interest educational and informative about the medical care provided by some of our best physicians in our country right here in the Borderland from all of us at the El Paso County Medical Society please enjoy tonight's program [Music] have you ever felt like you were having digestive issues like your stomach just not emptying into where it needs to be and there's just a rock in your stomach we're going to talk about that this evening it could be a lot of things but what we're talking about this evening is gastroparesis and to Define that gastroparesis is a disorder that slows or stops the movement of food from your stomach to the small intestine it's when your stomach muscles don't work properly and your stomach takes longer than usual to empty into the intestines and thus delays digestion and it results in what Dr McCallum calls the wicked three which is nausea vomiting and severe abdominal pain we actually have a gastroparesis research team here in El Paso and we have three of them here with us this evening and we want to say thank you for Texas Tech University Health Sciences Center in collaboration with the University Medical Center for underwriting this program and also a big thank you to the El Paso County Medical Society and all the doctors for underwriting the show and producing the show for 26 years now I'm Catherine Berg and you're tuned into the El Paso physician [Music] thank you thanks for tuning in we are talking today about gastroparesis that is a digestive issue we in regards to the stomach muscles and how it enters into the food enters into the small intestine and with us this evening we have three doctors who are on a research team that deals with this and we have Dr Richard McCollum who has the longest title Vinnie doctor I think we've ever interviewed but he is Professor of medicine they're all very important so I want to make sure I get this right professor of medicine founding chair of the Department of internal medicine and the director of the center of neurogastroenterology and gastrointestinal motility research hi Dr McCollum nice to see you you're doing cancer well done as usual it's uh it's great to be with you you're the the queen of GI so to speak we've done many many shows together and uh always enjoyable you're educated prepared and the audience is going to hear a great show tonight well there's a lot I learned just doing some research on this show so I'm looking forward to learning more uh we also have Dr Irene sarochek and she is a professor of medicine director of GI motility and neural stimulation research also at Texas Tech Health Sciences Center University of university medical center and then we have Dr Brian Davis who is Professor of surgery and medicine and the director of robotic surgeries at University Medical Center in El Paso welcome to all of you uh Dr McCullum is a veteran and so I'm going to start with him but for our audience it's always nice for them to have a bit of a background even though I gave your titles they'd like to know okay what what does that really mean um so Dr McCollum in reference to what we're talking about today is I know you you know we've done many shows before forbid in reference to today how is it that that you are on this program today and talking about what we're talking about again gastroparesis which is not an easy thing to say 20 times right Catherine well we've had many shows and uh they've often brought up a specific little new procedure a new diagnostic a test new treatment but really today what we're talking about is what I've done you know most of my academic career which is to study Gaston test for motility EG how the stomach empties and works as you've pointed out and to try to treat some of the problems with have sabotaged our stomach so I do gastrointestinal motility slash gastroparesis research that's my reputation and that's what brought me really in some ways to Texas Tech to enhance the research here on a given day on a card carrying gastroenterologist doing the right things to try to help diagnose some GI problems endoscopically clinically and by teaching our students residents and GI fellows just a little bit of a job right that that's a lot but I want to say also the good thing about tonight is and the audience may not have had this often this is not how to continue an entity how to give them a insight into something that's continuing and progressing tonight we are bringing you the solution of a problem we have treated overcome and resolved this problem gastroparesis so the audience is going to get insight into the future the real deal not just another chapter and I like those again to me a lot of the golden nuggets are dropped prior to the show when you all are talking with each other and how things are done so we're going to actually have some some neat um gadgets so to speak that we're going to refer to this evening uh Dr sarochik Sato check I would love for you you've been doing this research for a really long time and uh Dr Davis is giving you lots of Kudos and I think he will give you some more in a little bit too but to describe your discipline in regards of what we're talking about tonight how would you do that I probably should start with the fact that um 26 years ago when I started to work in the United States I'm a daughter McCallum and he said let's do something what nobody wants to do it and I got very happy and enticed to be pioneered with whatever he was on agenda I had no idea this was Castro parisis it was long time ago this was at the University of Virginia Charlottesville the VA we worked for a very short time there I learned what gastroparesis means I know you have a cat girl it is worth in half Castro means stomach Perez's always means something is paralyzed so here for patients to remember the name of this condition is paralyzed stomach it cannot work and we are looking for the reason how we can diagnose how we can help and what we can do on the end to help them out so beyond the clinic which actually is very limping if it comes to the gastroparesis as a condition with symptoms which you mentioned very debilitating symptoms nausea is very underappreciated actually symptom patients they talk about it but it's very hard to even feel sorry for them because we don't see absolutely anything how this affects their quality of life how they function we see when they vomit and that's another very prominent symptom in this a condition with the abdominal pain early satiety there is a bloating fullness and lack of appetite so when everything comes together it just is very hard for patients to be happy with their daily activities and that's why the interest of gastroparesis was just something what we took together many years ago and moved with the idea and concept of moving forward from the area when Dr McCallum and years ago when we started to work together he was working on a device and here is the one prototype which actually was used on a patient but big bulky device which was used many many years ago before 1996 to stimulate the stomach with electrodes which were attached and this is external device while I'm showing this because that's how we started this is our history from UVA and because of the um passion for this because of the lack of a understanding how this condition even is generated and what we can do about to help our patients we are absolutely made a tremendous progress in the future and that's how we have done studies first in the whole entire world whenever at the University of Kansas Medical Center and one day we said we are going to implant devices in patients with gastroparesis and will be internal not external not big bugs we'll do something much more patient friendly and I think we'll talk about this a little later also but from here to here so here is our 26 years of work we have idea where we come from here further for a discussion but um that's how we started we were very brave we have done patients from all around the world they were coming to see Dr McCallum it's a legend Castro Paris is in mccallum's name absolutely that's how I called it probably doesn't even hear me you know in the clinic telling this but but that's the truth everybody knows he's he's very very passionate about this and very devoted to um make this um feel more understandable for our fellows and our residents and obviously helping patients so what we do here besides the clinic because clinic and the list of drugs for gastroparesis I think the mechanical relation is very short but on the top of this we're doing research and that's how I come in to help out all those clinicians to run around and do what they have to do but if patient is beyond what is on the market then we step in and we do research nice and that's how we were able to be approved by National Institute of Health to be on a Consortium for gastroparesis we are one of six sites and they are a other very prominent schools from United States which are working with us there is Harvard University Temple University there is Mayo Clinic we have Wake Forest uh Jacksonville also a school of medicine and John Hopkins in Baltimore so here we are in El Paso doing something called Big institutions are doing and we are very proud that we can contribute with our patients from El Paso because that's our practically yeah and they're part of that research but I'll tell you there's a mecca for the NIH grants and and investigations because we bring Hispanic patients right they are Priceless so that's why uh we we like to have the difference in a a not only NIH grants we also have Pharmaceuticals in Trials I'm going to apologize yeah what I'd like to clarify is that there's a huge underserved population of diabetics and what we recognize in a national level is the populations of the U.S Mexico border are receiving inadequate treatment for diabetes and often are misdiagnosed and ignored by the average medical practitioner which is where are having a disparity focus at Texas Tech and University Medical Center really allows dedicated clinicians such as Dr sorosi Who not only writes the NIH Grant but passionately follows the patient before and after surgery and has a keen sense of every symptomatic variation that can be recorded studied for research and also counseled for these patients because they're lifelong patients after they've entered our system right and I and I wanted to not reintroduce you but Dr Davis again you you've been part of this this big picture as well and I I know that you mentioned earlier about the vagus nerve and I want to talk a little bit about that because all three of you now have been in this in this world Dr McCallum explained that to our audience a couple of months back and this is the nerve that registers nausea the nerve that creates etc etc so the vagus nerve so again and I'll go back again you are professor of surgery and medicine and director of robotic surgeries at UMC um in that sense too though you were talking about how the stomach does not always communicate I guess is the best way to describe it with our uh our muscular system with our nervous system Etc and if you can kind of take it from there we'll talk about things in a pretty simple fashion the vagus nerve has fibers that go to the stomach that do multiple functions including opening the outlet of the stomach called the pyloris muscle it also directs as the central Governor the motility of the stomach it leaves the brain travels on both sides of the esophagus and then splits into multiple branches where the esophagus joins the stomach so in essence this is a prime driver for the motility it is also a prime driver for nausea and vomiting because it sends fibers from the stomach Too part of the brain Thalamus which is a fancy term for Grand Central Station that mediates the knowledge the vomiting response in the chemo receptor trigger Zone which is the same thing that happens when too much alcohol is ingested when poison is ingested or anything else the brain sets off the signal it says we must vomit so the big misperception with what we're dealing with in treatment is this is not driving the stomach to improve motility what we're doing is we're telling the Vegas to be quiet by quieting the Vegas we are able to say to the brain it is not a good time to have nausea and vomiting and this nauseated vomiting is the crippling symptom that brings people to the hospital prevents them from working taking care of their children having any kind of quality of life and that's what fascinates me because we talk often about the the motor skills so to speak of you know what's happening physiologically in this system it's like how do we get the muscles to do this but but how do you I mean that's where the nerves come in that's where the brain has to say something to the rest of your body to fix what's happening it should be noted in the developmental research that this team has attempted to stimulate the motility of the stomach to improve the trouble as a patient has to carry around a car battery to make that happen and you were talking about that earlier exactly the car battery to make that happen you had something you wanted to interject well this is very important for patients because it was mentioned we have a problem with diabetics here in El Paso a huge percent I think we have more than 20 percent of people here who have diabetes and how too easy you can understand why we have paralyzed stomach because that's what we're talking actually in a box we call Big Brain and a little brain which is our stomach so those two brains they have to talk with each other and through the vagal nerve which takes the message from one area and brings for you to understand so when you are crazy on your stomach I have to vomit because the foot which is there in a stomach like you can imagine balloon which is full of everything what you ate in last day or even longer and doesn't go anywhere so what happened something in a muscle something is there something is paralyzed so nerves they don't work they don't allow for muscle to make contractions but Statics is absolutely affected and this is happening because glucose when it's not very well controlled in diabetics and you go to very high level and you go later you jump to very low one those imbalances they are very harmful for the nerves so the nerves are killed and that's something of what our team is also very pioneered with and discovering what is happening um in a level of the cell that's how far we go and deep we go because you cannot see with your eye anything in the stomach when you sculpt the patient but when you take biopsy during the surgery that's what you are doing from different regions of the stomach and you send to pathology and you find out the cells which normally will be inside such a number present there they are called cells of kahal interstitial cells of kahal ICC we can use abbreviation if they are missing they are depleted this is the problem why the stomach cannot work and so it's almost like you can tell that the cell is stressed is that yes what it does is it sets up a level of chronic inflammation so we need to step back and talk about is it high blood sugar levels create a state of chronic inflammation and what happens is the arteries become brittle our nerves become brittle this is where we have lost Invasion loss of kidney function people have incredible pain in their toes and their feet and what they also have is this bloating of this first chamber of the abdomen it's basically bloating of that meat grinder it's supposed to work in the Vegas becomes brittle because the blood vessels are brittle it's not going to fire properly in the meantime it's not going to send signals properly the loss of cells of kahal indicate that there is an inflammatory process where cells that are meant to clean up inflammation start attacking the stomach itself okay so we call them neutrophils and macrophages they go and they eat the pacemaker this alcohol is the pacemaker of the stomach so that Vegas fires to the alcohol cells and says time to push in the right direction in the meantime the high glucose or sugar level creates that state of inflammation which creates end organ failure throughout body okay that makes sense to me so when you're talking about earlier too you're talking about organ Salvage and the stomach and fixing things but it's not necessarily fixing the stomach it's fixing the nerve I want to I want to back up a little bit go ahead sorry I'll back up first yes the public should know taking out that failing organ can be very dangerous can be fraught with complications also could be fraught with tremendous changes in the lifestyle in reference to how and what people can eat and how they can adapt so there are several people today that say take out the entire stomach or they say do the weight loss surgery living in a very small pouch but they're not talking about is the multiple functions of the stomach because when you have the weight loss surgery it creates vitamin deficiencies it creates anemia it creates osteoporosis multiple complications because we're ignoring by doing that the multifaceted complex function of that stomach in the entire system so when we say we're pioneering organ sparing surgery we're giving people quality of life while maintaining the multiple functions of the stomach as a immune organ as a nutrition organ as a reservoir and allowing people to regain quality of life with avoiding the complications normally seen with weight loss surgery and Dr McCallum you had a good point prior to the show too that people look at the abdomen like that's the stomach well it's not the stomach and so what I'd like to do um and we'll show a graphic too it may be almost simplistic but I'd like for you to describe uh the digestive system yes it goes through the esophagus it's in the stomach now and and with this specialty we're talking about today with gastroparesis what is happening how big is the stomach let's talk about that um how big is the small intestine where that's going so just kind of give a graphic description of of everything that we're talking about because Dr Davis was talking about the the function of the digestive tract which we think again is is so easy from A to B but there's this is an area where things are are being held up so to speak right so from the mouth to the end of the esophagus where Dr Davis describe transition into the stomach is about 40 centimeters okay and then from the top of the stomach to the end of the stomach the pylorus which Dr Davis implied is controlled by the vagus nerve and we enter the small vowel that's about another 30 to 40 centimeters and then we have 20 feet of intestine Smallmouth going down to the beginning of the cold then the Colon's another six feet to the rectum so it's really a huge organ and we we talk about Atomic doctor well the stomach gastrointestinal you know Anatomy doctor I'm in the true stomach which is about mixed in from the diaphragm to the pylorus which is not as long as most people think it is it's probably only about 30 centimeters so if you're looking at this cup just just visually how how big is the stomach in comparison to this cup would it be the fist of where the water is it filled up it could be about the size of that cup okay when totally sort of Thanksgiving dinner that might reach that size right okay so if it's okay for me yes please Dr Davis you know the stomach has so one thing we talk about in biology is the cow has a four chambered stomach allows it to eat grass the stomach itself does not have four chambers it has different areas with different patterns of motility and we know is is that the upper part of the stomach or on the esophagus is called the fundus which serves as a expanded Reservoir or a giant Sac that allows people to eat as much as they want on Thanksgiving and then we have the body which tends to push toward the Antrim which is right before we get to a circular ring that is the outlet and the goal in the movement from the body to the Antrim is to serve that meat grinder function because we have a large meal the body needs to break down with both acid and mechanical motion these large pieces of meats food into smaller particles that can be digested by enzymes in the small bowel so we talk about Transit which we'll talk about as part of the diagnostic Paradigm is that after that Thanksgiving meal there can be up to four hours of digestive time where the turkey needs to be crowned in order to be properly absorbed as proteins by the small intestine I understand when we talk to students about the stomach and gastroparesis I very often ask the question how big is your stomach you use the glass here but something for people to remember and have always available in them is as big as my fish right and that's what so so your hand is bigger of course that's mine so can you imagine to put your Thanksgiving dinner in this much of space I'm just thinking about this place so that's what we feel as a surgeon the capacity the capacity to expand and create pain can extend well below one's belly button and we have seen this comes back enlarge into an extent where it creates incredible gas bloating pain so we should we should watch the functionality is much more complex than a simple cup that fills it comes down to probably you know if I were to actually take you to the operating room would be three of your fists the first fist is that fundus the second being the body and the body squeezes toward that Antrim where you really get the mechanical motion so the body's main function is produce the acid the Antrim is where the food really gets ready to be ground and it provides feedback to produce more acid so what happens when you have complete loss of that grinder in the Antrim that you have overproduction of acid you have risk of ulceration you have risk of perforation you have increased size of the stomach which can extend it press on all other abdominal organs and create incredible pain and discomfort sometimes it still even migrates into the chest oh geez so the bottom line is for patients to know your stomach is not big is this is your abdomen yes and stomach is small organ on its own which is hanging in your abdominal cavity and we have to distinguish this because there's a liver they are the spin kidneys everything else on the horizon and this is just small stomach it's very important little brain little brain um Dr McComb how how common in general is gastroparesis I mean is this something that it's interesting we're talking about Thanksgiving and I think all of us have felt that right so we just ate too much and you're thinking oh if I can just have five more minutes for some of that to go down that I can fit some more in that's a whole different situation but if we're looking at someone truly that has gastroparesis how many people does that affect um and let's maybe talk about Thanksgiving and then talk about issues where oh you know what I really do have a problem I really need to go to a doctor and get this checked out well if we write a chapter we try to come up uh with that figure now sprue or celiac disease which is you know people would think it's endemic based on menus and restaurants that's about one to two percent of people okay hepatitis C which is rampant something degree is three percent of people we're actually above that we're in the five percent range so if you look at El Paso whereas a million people you could say we're talking almost five percent of those people which would be you know 50 000 patients oh could have forms of gastroparesis dominated by diabetes but there's other way there's other ways to get it an unexplained viral insult can damage your nerves and damage the muscle or the surgeon can accidentally cut the vagus nerve the conduct with the orchestra and the orchestra is very confused and the stomach stops but the dominant one at least in this area and around the country 50 or more long-standing diabetics okay which is our very large population here um when we're looking at and I'm just throwing this out to anyone and Dr McCollum I just kind of have your name on this but the diagnosis of gastroparesis so if you're if you're looking at you were talking about biopsies earlier and we're talking about looking at different cells Dr Davis um whoever wants to take that in but but how is true gastroparesis diagnosed I'm not the final answer we are experts with the National Institutes of Health and the National Institute of diabetes Consortium on taking biopsies and we have had studies where we have tried to take biopsies for cells of alcohol using a scope the mystery of this is this is a primarily underserved population because the average clinician does not know much about the disease and does not know when to refer and I'll let Dr sorosiak talk about the real diagnostic algorithm because the biopsy is actually the last thing that comes when I get to operate and we already mentioned that this is functional disorder which simply means nothing is obstructing on a way what you could remove during the endoscopy there's no answer which causes this because there is a different name of the condition but here actually endoscopy is done just to prove the point there is nothing that visible to the eye of the Doctor Who is coping the patient so what do we do stomach is not affected nothing visible with your eye many patients and actually I left today that one in four people in the United States has symptoms like gastroparesis so this is very popular and I have not all going to diagnose with the same condition that's why we had to have some steps in our diagnostic uh Paradigm to make sure we exactly know that this group of symptoms is called a orchestra playing in a stomach is actually due to the fact that stomach is paralyzed and there's only one test which is done by us here at the and many other centers academic centers when we use special protocol is conducted by the nuclear medicine Department Dr Jesus Diaz is our delegated person he collaborates with us on a NIH Grant also and they perform the test when the food which patients they have to eat before the test starts is labeled with the eyes atop and this is gastric empty nuclear medicine a test when the egg bitters with bread and some gem a little bit of water very often it's not very tasty tastes like metallically kind and patients who are nauseated and they are vomiting they don't appreciate the taste of this at all but they go for it because they know the result of the test will give very good yield to choose now this is gastroparesis or it's not so what will be the next what will be the treatment what we can offer at this point what will be in a future and the delayed gastric emptying is just the magical number which we get from nuclear medicine which tells us that for example if the 100 is the amount of food patients they eat with those labeled eggs after two hours they will have less than 60 percent left in a stomach slow let me say that again so after two hours they would have less than 60 left normally so in gastro but I think this will be delayed so they will have much more with patients who had 90 percent still present in a stomach at second hour when the test started but the magical number comes from the fourth hour this is when everything what was discussed in physiology and in a sense of this condition pathology of the disorder we have normally we expect to have only 10 percent or less than 10 percent left in a stomach at fourth hour because this whole test lasts for an hour but patients with gastroparesis when they I actually I have 54 70 sometimes even higher above 10 percent is allowed us to make a diagnosis that this is delay this is delayed gastric emptying which is related to the paralyzed a condition so this is a third hour centigraphy gastric empty test done by nuclear medicine department and we are utilizing this as a standard of care for our patients most recently we came up because we're doing studies before in 2004 in the University of Kansas we brought another a very important and sometimes actually this is very good I'll mention just for sake of being aware of this because we have this test available through Texas Tech right now and done many patients this is capsule which is called smart peel the smart pill and it's very smart it's very smart we have watched Smartwatch smart everything and here is smart peel this capsule is a size almost of the prenatal vitamins which women they take or they are pregnant and his Hearts feel pretty big but I tell you so smart because it has three different sensors inside and Those sensors are able to make the recordings of pH the level of acid in a stomach or any region of the GI tract when travels through there is a pH sensor and temperature sensor so the the patient swallows the capsule they have receiver under linear and they go home and they live normal life they have to fast on the beginning we just tell them how to follow but then on the end of the study what we are getting from the patient we can put on a computer and use motility software which will show us exactly how long this capsule was in a stomach for how long it was in a small intestine and in a colon and we can then calculate whole gut Transit time which is very important not only for gastroparetics but because diabetes doesn't have mercy on anything in a GI tract affects the stomach and many patients they have problem with constipation because they are nerves too and they are they are exposed to this kind of imbalance so we can exactly calculate how long those regions they last for and then we can come up with the idea and the decision this patient has a very delayed gastric empty and maybe it's 40 hours worth patients recently and then a small intestine normally six hours travels through this and it's like 50 70 hours through the column that's normal normal timing but if somebody will have this for seven days then 160 hours of holga Transit time yeah so this smart pill even though is small and it doesn't cause many problems patients they don't feel when it goes through the GI truck that's something what is available and we are very happy that we are able to give our patients in El Paso as another tool to measure their delayed gastric emptying but around the country it's Center graphic okay that's the gold standard okay and we discuss patients at meetings or presentations everyone says what was the four hour gastric empty show me the data so that that is what every hospital has to have so when we're in it just so I have this right to on a I hate using the word normal but I'm going to use the word normal and a normal digestive situation usually the majority of like 60 of the stomach is emptied out by two-ish hours Mossy Metals as we would say right if we're looking at 40 okay we're looking at so really a normal functioning uh stomach it would be between four or excuse me two in like almost four hours if you're up to four hours and you don't have the majority of your stomach emptied then there really is an issue and the reason I'm asking this is for the people who are watching and listening um I'm trying to figure out how they're putting their heads around it like okay this is what I am feeling I am feeling like I still have all of my food in my stomach as I said in the beginning of the show like there's still a rock in my stomach five hours later six hours later and this is this is the question right so you have to be aware that you know this meal was designed by us for patients who are nauseated getting up at eight o'clock in the morning to eat this not exactly great meal so we have to do a 250 calorie meal two percent fat and we know they'd eat it but you're not going to eat this tonight you know you're gonna have a three or four course dinner you're gonna have something else another day so we've never done a truly physiologic gastric evening this is not official small meal it's like the treadmill if you can't walk on a treadmill there's no way you're going to jog and there's no way you're going to run around the block so this is walking on the treadmill gotcha it's a very artificially small meal if you can't pass this test then your stomach is not ready for anything Dr McCallum is an expert at we do know there are other syndromes like cyclic vomiting rumination syndrome that do not have abnormal gastric emptying so what we have is a for a surgeon a simple reductionistic paradigm any family practice or internal medicine doctor can order this test the nuclear medicine team will interpret the test so we're talking about is a clear correlation of symptoms because the cyclic vomiting rumination do not respond to the gastric stimulator or pyloroplasty and in many cases cyclic vomiting and when you say cyclic vomiting this is just consistent vomiting is this what do you mean is an expert in okay multiple motility disorders of the esophagus and stomach so we talk about a half dozen disorders that could mimic gastroparesis we have to get reductionistic like surgeons and go simply what is the one test that will determine efficacy of surgical intervention and that efficacy of surgical intervention is delayed gastric emptying so the percentage for the patient they need to understand explaining their symptom complex is very important for the primary care doctor so that they're triggered to get that critical test and the other symptom is if they're not getting symptom relief from medications that are commonly prescribed they also need to consider seeing a specialist which is Dr McCallum who is also the world expert cyclic vomiting and rumination so on that note when the patient has the first person they're going to come see and I know usually it's a general medicine person whatever but let's say it's you and they come to Dr McComb now and they're like okay this what is the description that they give to you of what they're feeling like what are their symptoms and how did they describe those feelings well the most sensitive symptom is what's called early satiety doctor I can't finish a normal sized regular mail that I used to eat no trouble six months ago or a year ago I can't eat more than half the meal I go out with my husband wife to the restaurant I can't finish the meal then we talk about I feel nauseated I have to really stop eating too much I know if I eat too much two three hours later I'm going to vomit and I've got extensive feelings of fullness which may evolve into true pain and so there's a constellation of symptoms that evolve and we try to tease that out to the patient we are it's very leading questions to make them sort of admit that you meet the classic signs and and I I like the way you described it there and um Dr sarochik I would like to ask you because you I find are the ones that are pharmaceutical questions so there are different medications that people take that could also either complicate this or May look like something else is happening and the reason I'm bringing this up too is that depending on what the population is taking at any given time I'd like for you to talk about some of those other medications other Pharmaceuticals that are involved here that's actually very good question because before the patient goes for Saturday we use this as a last option and and it's a very good one but they have to be by the FDA they had to fail everything what is on the market so each drug which is presented and is a available for patients with gastroparesis they have to be tested they have to be failed patient becomes refractory to those drugs and then what else you do and that's why we want to tell patients here in El Paso and everywhere else please don't take answer from anybody I had nothing to do with you so please just go away from my clinic because and don't come back yes there is always as you know people are working on Research making a new um absolutely drugs available on the market and that's why we test everything and until we sent to Dr Davis so there are two major groups of drugs which were using condos patients and sometimes by the way by giving the drug on the patients based on the symptoms we don't know yet but trying the drug which helps to empty the stomach and they are not delayed those patients with gastric emptying is not going to help with symptoms because it's not the reason why they are nauseated why they vomit we have to look for another explanation like strictly vomiting contamination syndrome so those two groups one is prokinetic group of the drugs and second is anti-imetics so drugs for the the one which help to empty the stomach they're supposed to make Muscle contract much stronger and move food towards the pilarious and push this down into the duodenum and second is just to take care of nausea and vomiting a center for nausea and vomiting is is located in our brain it was mentioned before chemoreceptor Triggers on is very powerful Center which actually one gets the message through the vegan nerve can make patients to feel nauseated and vomit so we have the drugs which have different mechanisms of action and they are helping out with controlling nausea and vomiting on its own many popular drugs which are on the market and and they are acceptable for patients to try Phenergan we have promethazine we have zaffron on down syndrome we have actually um in Titan is not used right now very popularly compassing and something what I found out recently being very well actually accepted by the patients is couple I'm in touch and this is the patch which goes behind the ear for three days and maybe you have seen people going on the cruises and they have motions yes and for pregnant women these very good idea sometimes so that's what they use with the scope alarming patch behind their ear and is is very helpful and the other group just automation few drugs there's only one which is officially approved by FDA for gastroparesis is called metoclopramide many patients they try the drug has many side effects so we have to be very careful loud Doses and it's available not only in tablets but it could be given as injection and in emergency room also so this is the only drug which officially can be prescribed by doctors in a any kind of Center or clinic in town but then this is it practically and I have to tell you it hurts so much all of us who are working in a Arena of gastroparesis and going through the pharmaceutical studies we have done together with Dr McCarron probably 100 different trials with probably 20 new approach of the mechanism of action of drug which will help to empty the stomach and you know what until now we had one major one which was approved recently on me and this is red Landing spray from the evil company the drug which is available but we've failed with many others and the reason for it that's why I said well almost crying seeing the situation because we would love those drugs to work but because the condition is functional your brain is too powerful to distinguish sometimes how much is the true action of the drug and what is done by myself thinking this drug should help me because all those studies and very important studies they have to be done based on a design which is a double blind placebo-controlled study which simply means patients are getting the drug from us and they don't know and we don't know if they are getting the drug which is active or this is actually placeable and that's for the study we have a healthy debate because you've been studying this mechanical device known as the gastric free electric that was my next question so I'm glad we're talking we're getting into that here's what I'm going to tell you is quite clearly that the medical community and the medicines that are prescribed have little or no effect and leave people in a state of abject misery trying to cope with symptoms and I will tell you exactly from a surgical perspective what I debate with gastroenterologists Nationwide we do not have accurate staging of the disease so when you talk about reg gland which simply works on receptors to make the stomach push harder by the time the patient presents with chronic nausea and vomiting there are no receptors for regulator act on so when we talk about Nationwide the patient's doctor accountancies these are the patients that are so sickly cannot leave the hospital because the rig land won't work so having an accelerated Reglan is again getting down to the points the muscular motility is not the driver of this what we have to understand is that the effects of Compazine Phenergan Zofran is to basically try and get the chemoreceptor trigger Zone to be quiet now when you tell the brain to be quiet it's a very interesting problem side effect profile wise because it also puts people to sleep and most people do not appreciate living a life of chronic fatigue and sleep in the meantime we have to talk about options that return people to Quality of Life normal function and because your work for 26 years remember I've only been here with you a decade so you've got 16 other years to tell me how good your medicines work because I know where to be checked for the for the reason that FDA approves even the device gastric electrical stimulation system for patients who failed everything else therefore following the rules we have to try and we have to document because insurance has to come in and has to pay for it as many Logistics which are behind and we absolutely play cuts the right way there are drugs which are investigational and I won't mention the name on on this panel this is a great segue because study the Dr McCallum was pivotal in published in 2001. was a crossover study that you have told me was biased by patient recall bias in memory and the design of a randomized controlled trial means there can be no recall bias or memory of the device and what has happened is the great debate causing human device exemptions the human device exemption is this is the last resort the goal of the RCT is to make this planned standard of care therapy for gastroparesis because now we have proof death independent of other mechanisms and theories that this electrical stimulation has a clear effect on nausea and emesis that cannot be reproduced by other medications cannot be reproduced by other surgical therapies and is clearly indicated for every patient so in the meantime as the evidence mounts we expect within the next decade that when the disease is staged properly and recognized in its exact stage that people can progress to getting this is first line therapy through this we have done implantation of the device and many other centers are doing and this is the device for the term as Davis mentioned there are two electrodes and they are on the end of the lead which is 35 centimeters long um and there is an electrode here and it has to be put precisely in the wall of the stomach in a 9 and 10 centimeters from the pylorus on a greater curvature of the stomach so putting this electrode one centimeter just a little bit of this metal is there and then this is connected with the device which looks like pacemaker for the heart exactly the same size and shape and this device is actually put in an abdominal wall in a packet which is made there and is connected with um so you can imagine this in the stomach there are two of them and then devices on the top of in a abdominal wall for communication and interrogation for checking the devices what Dr Davis does a couple different questions you see the audience may want to know is we're putting needle through the wall of the stomach so in the meantime I drop a camera in the inside of the stomach and I make sure we do not penetrate the stomach now what Dr sorosiak has published on over years of researches is it really a big deal if the migrate if the device migrates into the stomach and you find the lead poking through them all the stomach and I will tell you surgically because of the Advent of laparoscopic and robotic surgery with small incisions this is quite a simple problem to resolve good without evidence of long-term infection and that people can safely have small incision surgery smaller than the size of my index finger removal and installation of both of these with very precise suturing and placement with minimal long-term risk of infection when proper care is taken of that surgical wound beautiful and so this device how is it controlled from the outside or is it is it yes okay this contract you can imagine if this is a in a patient and has to be positioned in a packet which is very visible we know what it is then it works on its own patient doesn't have any control over the parameters cannot stimulate stop turn off nothing very powerful magnets if there's somewhere around the patients without them just be careful then what we do when they come to see us we have a program a special programmer and we have the head of the programmer which goes on a tap you can imagine this is in a patient's wall inside is hidden it's not visible everything is internal then we put on the top of the abdomen and then I am able to interrogate and tell what is there in now actually impedance that is resistant between two electrodes because they are one centimeter apart they have to be precise so in late terms it generates a charge and the charge tells the vagus nerve to be quiet and the charge can be changed by the experts because if the charge the initial charge doesn't work then the charge can be increased in order to the algorithm to increase the charge there to get the vagus nerve to be quiet so some people are going to respond to lower settings and then some people are going to have to dial up the charge in order to do this you did mention that time was closing so in respect to the we have a whopping six minutes though we're good the great debate in the care is that many people in the surgical Community feel that cutting the Gateway muscle to the stomach called the pylorus which actually accelerates gastric emptying can cause Improvement of the symptoms but this goes back to staging Because by the time they come see Dr McCallum the motility is zero in most cases so even some improvement in motility does not improve nauseating vomiting and I have colleagues Nationwide who swear that cutting that muscle is the key to solving the symptom complex but what happens is from my colleagues at Cleveland Clinic as they admit that all of their patients do not wind up in the hospital they're outpatient therapies now everyone that comes sees Dr McCallum can not literally leave the hospital they're losing so much weight that they're in a tragic state of malnutrition so it's a different stage and we know that maybe cutting the muscle works when the muscle still can squeeze and that way the Gateway is open what we've done in this study is that over a extended period we do the muscle cutting and the stimulator at the same time and half the people don't have the stimulator turned on so a doctor is an expert in measuring is there's a real question does the people do the people in that off group have any effect on the nausea and vomiting and what the study says is that the pyloroplasty or cutting of that pyloric Muscle really does nothing for the nausea and vomiting and that's where we have seen this in published work that it is a very significant symptom correlation that can help this become standard of care for gastroparesis as in the reason we are here is only to tell everybody that we are were here present for patients to feel better we are not giving up on any of them even though we have done the stimulation for many years without ramacan starting in Virginia in Kansas with Dr Forrester we were able to control the symptoms of the patients but we could not improve gastric emptying because the door was closed the pillars were stuck so that's why we came up with the idea to add two things together because in a science when you show somebody your symptoms are better but mechanically you do nothing right because gastric ending is not improving then we decided to go with a double blind Placebo control study when we implant the device and we do pyloroplasty at the same time so patients are getting combat combination two sets two procedures at the same time but that's what is very tricky here because half of those patients and nobody knows Nobody Knows the device is on or off they don't fear any stimulation they shouldn't if everything is working well so those patients they go for three months without even knowing if device is helping them or only paleroplasty which is again Open Door clarify for a moment so in looking at the entire body of research we talk about these symptoms that people have we know that pyloroplastic and accelerate gastric MTN can help symptoms of early satiety and can help symptoms of abdominal pain what we do know is these people do not get adequate relief of the nausea and vomiting complex so as we're talking about the two separate disease processes that I debate with people across the country that is the neuropathy which causes the knowledge environmenting versus the motility and the motility in the end stage patient cannot be salvaged therefore we've done with the randomized controlled trial that separated these two groups and said the people in the off position with the stimulator have relief of the satiety and some relief of the pain but they do not have relief of that Cardinal thing that keeps people from going to work taking care of your children and contributing to society which is the nausea and emphasis is where I make the argument that when more people receive this therapy at accredited centers with experts within a decade we will have evidence to make this first line therapy not Last Hope Therapy as we've studied the brain Imaging with pet scanning and this device although it's in the stomach sends a message up the vagus nerve up the effort limb the century them and goes to the brain so we send a message which tells the brain don't be nauseated it's a direct image a direct connection to the chemo receptor trigger zone so we we're helping the stomach locally but we're also sending a central message and then we open the pylorus and food empties faster or normally at the end of the day so we cover all the bases basically the vagus nerve seems to be the superstar in all of this absolutely it is it is it's it's super I you I don't know when the last time we had a good debate on the study design that proves the theory yeah so we know as per Dr Soros he acquired the 2001 study he started a human device exemption and we know over two decades later from this study group clearly what the mechanism is because we have a non-biased study that says this is working with the neuropathy in the brain well the pyloroplasty is working with the muscle I would love to do this exact same topic five years from now because I know that just again healthy debate is where it's all at but we literally have like 32 seconds left so we can't but because can you imagine right now what we're discussing with Dr McCallum actually Dr Davis is involved in this too now we have another company which oversees this device can you imagine this device to be possible to program the way it will work only during the day during the meals no it would be so during the night is quite more than half of this device the the value of this device is is battery yeah so we have to save the battery we have so it lasts longer I'm sorry this is the future we're going to continue the debate you all have been tuned into the El Paso physician I'm Catherine Berg [Music] foreign [Music] [Music] [Music] foreign