So, I have no, I have no disclosures. And so, coming to the, so Matruta's talk is going to be on the limitations and the complications and the potential pitfalls of capsule endoscopy. And so, the panelists have kind of touched upon a lot of things, and it was an excellent discussion. So, I may have to repeat a few of them, but, you know, the PILCAM has been a revolutionary process in the examination of the small intestine, and it has done a great job so far in the diagnosis and led, you know, a path to also the double balloon endoscopy so that we can evaluate the small intestine. So, so far, there are these, the FDA-approved capsules that are available right now. They share most of the features, but they differ in a few technicalities, you know, such as the Matronix PILCAM3 has a real-time viewer, while the NAVICAM has the AI technology. So, only the capsule CAM vision has the 360 view that gives a panoramic view of the small intestine. And almost all the PILCAMs have the longer battery life now, you know, it used to be eight hours, but the current ones have like more than 12 hours. The Matronix is the one, as I said, is the only one with the real-time viewer. So, the learning objectives of today's talk is going to be to identify potential pitfalls and how to steer clear of them, and also to kind of learn about the proactive strategies on managing and prevent complications of capsule endoscopy. So, when it comes to the limitations of capsule endoscopy, that can be kind of broadly put into like a few categories. The topmost one is the incomplete examination and followed by the challenges to interpret the capsule endoscopy pictures, which Dr. Harris has given a very nice review about, and that can lead to poor diagnostic yield. And the main thing here nowadays, you know, even though we have made a lot of advances in the PILCAM, it still lacks therapeutic capability, you know, there's no insufflation and we cannot take any biopsies. So, it is still a diagnostic tool that we have within our disposal. So, the complications can be classified into like the main important one is a capsule retention, and the other ones are aspiration, you know, which is rare, and bowel obstruction that can lead sometimes to perforation requiring surgery. And the other important one is the misdiagnosis, kind of missing lesions that are significant and also, you know, over-diagnosing, like mislabeling the findings that can lead to further testing, which can add to the patient expense and also the healthcare cost. And regarding the interference with the electromagnetic devices, Dr. Harris and Dr. Cave during the panel discussions have nicely kind of explained. I will go over this a little bit on that. So, coming to the limitations of the PILCAM, of the capsule endoscopy, the main thing is that incomplete examination, which is kind of defined as when the PILCAM does not reach the cecum or the stoma within its battery life. So, right now, you know, the PILCAMs that are available have a battery life of more than 12 hours. And it is seen in about like 16 to 20% of patients, and there are certain risk factors by which we can identify in the pre-procedural phase to see which patients are at more risk of having an incomplete examination. And elderly people, people who have diabetes with their slow gastric mortality and intestinal mortality, Crohn's disease, who can have strictures, and any causes, including medications that can prolong the gastric transit time. And if a patient has had previously an incomplete exam, and also patients who are hospitalized. These are the patients, you know, who are at more risk for having an incomplete exam. As Dr. Vance has said previously, patients having an altered surgical anatomy, such as gastric bypass or gastrogynectomy, has not been shown to have increased risk of having an incomplete examination. So these patients can swallow the PILCAMs, they need not have to have it deployed endoscopically. So among the limitations, I'm going to focus a little bit on the prolonged gastric transit time, which is kind of, you know, defined as failure to reach the small intestine, like the duodenum, within one to two hours of ingestion. There are several diseases, you know, the patient-related factors, including their comorbidities, having diabetes or gastroparesis, can cause this. And I just want to touch base briefly about the GLP-1 agonist, you know, nowadays there are many people who are on GLP-1 for, you know, weight loss and also for diabetes. So there's this nice study that was done, it's a retrospective cohort study of 136 patients with diabetes with matched controls. So they looked at these patients who were on GLP-1 versus the matched controls who were not on GLP-1. And what this study showed was that there was a significantly prolonged gastric transit time in patients with diabetes who were taking GLP-1s. It's 99 minutes versus 25 minutes who had diabetes, but not taking GLP-1s. And also there was a higher rate of incomplete small bowel evaluation, 23% versus 4.4% if you were taking GLP-1. Even though there is a prolonged gastric transit time, but only about, you know, 7.4% of patients who were on GLP-1, they did not have the pill camp passed from the stomach. So basically only 7.4% had a gastric retention of the pill camp. So it eventually passed, even though it took a much longer time. So what are the strategies to mitigate the incomplete exams? So before we decide a patient needs to get a pill camp, there are certain things that should be considered. Is that use a capsule that has a longer battery life and then, you know, have the patients come back after 12 hours. Generally what happens is that, you know, patients do come in the morning around eight o'clock and then are told to come back in the evening around five o'clock before the clinic closes. So that's an eight hour time, but I think, you know, having them come back the next day would actually improve, you know, the completeness of the exam. Then there is this role of prokinetics, which the panelists have kind of touched upon previously. So there is a selective role, but you know, it is still kind of up in the air. And whether to use a real-time ureter to make sure that the pill camp has exited the stomach and also using artificial intelligence to improve the interpretation of the findings. So these are the things that can be deployed, even though they are not readily available, but you know, something to consider in the future. So I'm going to touch upon briefly on the role of prokinetics to improve the completion rates. So the one thing is that even though they kind of improve the gastric mobility time, there hasn't been any yield in increasing the diagnostic yield or also kind of increasing the small bowel transit time. So one thing is that using the promotory agents may adversely affect findings because as soon as, you know, you do that, the pill camp just kind of bounces off in the small intestine and that may miss significant lesions. So it may improve the passage of the pill camp from the stomach, but it may affect the findings. So that's one thing that needs to be considered. So then who are the patients, you know, that will benefit from having the prokinetics? So the patients who have had an incomplete study previously and have had some risk factors for an incomplete study, including, you know, non-delayed gastric emptying, if they have anything, if they have diabetic neuropathy, because if they have neuropathy, then there is increased risk of having gastroparesis. If they are on any psychotropic medications that affect the intestinal mobility in an adverse way, and if they had any previous surgery of previous abdominal surgery without any risk for bowel obstructions. So you can also consider using prokinetics if the pill camp remains in the stomach for more than 60 minutes, when you use a real-time ureter on the sp3 capsule. So the European Society of Gastrointestinal Endoscopy, they recommend deploying the pill camp endoscopically in the duodenum if it remains in the stomach for more than 60 minutes during the real-time monitoring. So but not everybody, even though the recommendations are there, it's not widely used. So does real-time viewing really improve the completion rates? That's one question. Do we need to use that? And if you are using the pill camp sp3 one in our practice. So there was a study that was done that looked into 858 small bowel capsule studies that were done over a period of seven years using the sp3 pill camp. And surprisingly, and there was an impressive completion rate of 94.6% in the studies. And the incomplete exam was only about 0.7%, even with the prolonged gastric transit times. So the risk factors that were identified in the study for an incomplete exam is that when they had a prolonged gastric transit time, if the patients were hospitalized, they tend to have incomplete small bowel studies, or if they have had a prior incomplete small bowel exam. But so, okay, so these are the risk factors. Once you identify the risk factors, is it cost effective to deploy the real-time viewing? Because you have to have the patient at the hospital, and then someone has to kind of be there who's trained to do that. So when they looked into that, they said that the direct cost of systematic real-time viewing, and along with the prokinetics, if the pill cam retained in the stomach was about 5,000 euros. So it is not, you know, like it adds to the cost of that. So still, it's not widely recommended yet, but you have to kind of take it by case by case and see like which patients would benefit using the real-time viewer. So some of the pitfalls of capsule endoscopy is low diagnostic yield, and there are certain factors that might contribute to that. And the main important thing, which was discussed by Dr. Cave and the rest of the panelists, was the patient selection. So it is really important to choose the patient in whom, you know, you think the pill cam is useful and that can direct their future care. The second thing is that timing of the procedure, you know, in relation to the GI bleed. And the third one is the quality of the bowel preparation. So when it comes to the patient's selection, Dr. Vance has kind of discussed on this. There are appropriate indications, you know, that have like a high yield. Those are patients who are having obscured and over-GI bleeding, if they had iron deficiency anemia, and especially if you think the anemia is coming from a small bowel source, and Crohn's disease, polyposis syndromes, if they had obviously an abnormal small bowel imaging, and also to further investigate any complicated or refractory celiac disease. So when the pill cam is used for conditions other than that, for like to investigate abdominal pain or for diarrhea, for a diagnosis of Crohn's disease or celiac as a cause of the diarrhea or for malabsorption, or for iron deficiency without any evidence of overt or occult GI bleeding, the yield is low. So the second thing is the timing of the procedure in GI bleeding. So if the pill cam is done within 48 hours of the onset of GI bleeding in hospitalized patient, the diagnostic yield of finding the culprit lesion is more than 90%. So that kind of helps with decreasing the mortality, obviously the hospital stay, and also the readmission rate. And also, the sooner the small bowel pathology is discovered, then, you know, the patients can have an earlier intervention. So if the patient has had the GI bleed, and then if you decide to do it as an outpatient, in outpatients in a positive study, like it has to be done within 15 days, two weeks of that. So the third thing is that, you know, the quality of the bowel prep, right? So do we give the prep, you know, what are the effects and what do we see? So basically, when you do the exam, what we come across is that lots of bubbles and foam and food particulates and the pill residues. So that obviously kind of limits the visualization and decreases the diagnostic yield. And sometimes, as Dr. Harris was telling, is that, you know, the bubbles may be misdiagnosed as something, you know, having like a polyp. So that can also be a problem. So coming to the quality of the bowel prep, you know, the practice patterns are very variable, as we have discussed before. The European Society of Gastrointestinal Endoscopy says that, you know, you can be like NPO two hours prior and then, you know, two hours later, you can have the clear liquids and solid food, like light solid food for four hours later. In our practices, generally, you know, we do like eight to 12 hours overnight fast. And then another important thing that was asked in the Q&A session was that, you know, having the bowel prep, is it necessary for the patients to drink the bowel prep? You know, the one thing I have noticed is that, you know, patients, you know, they're OK for having a pill cam as soon as they hear that, oh, by the way, like you have to drink a prep. You know, it's not the full Golightly, but it's half the Golightly, but it's still the prep. You know, sometimes that may deter the patients in pursuing the procedure. So the purpose of the bowel prep, you know, theoretically is to decrease, you know, the bile and the terminal ileum and the distal ileum. So generally, you know, the several types of bowel preps, you know, have been kind of advocated, a bottle of magnesium citrate, no prep to begin with, no prep or like a bottle of magnesium citrate or the common ones that we use is that, you know, two liters of Golightly to improve the visualization. But, you know, does it increase the diagnostic yield or, you know, when should the patients take the bowel prep? Is it the same thing as the split prep that we use for colonoscopies or, you know, like a one-time prep the night before, but there is no definitive conclusions to say that, you know, taking a bowel prep will increase the completion rate or also like increase the diagnostic yield. So this is kind of a little bit, you know, not very clear, but, you know, whatever works for your practice or for your patients, I think it's the best thing to do. But if a patient has had like a very poor prep before, I think it may be prudent, you know, to add some polyethylene glycol solution in that. So the use of anti-foaming agents like the samethacone, you know, does this improve the diagnostic yield? So using the samethacone, it improves the visualization of the mucosa, you know, you know, the mucosa are busted and there is no more foam, but there is no consensus on the optimal dose. So what dose is used and how soon before, you know, they need to take it and, you know, are higher doses of samethacone much more effective than the lower doses? So the higher dose of samethacone did not show any benefit over the standard dose. So it is generally like we do not give that in our practice, but, you know, that's one thing that you can also consider using the anti-foaming agents. So coming to that interpretation challenges, which are also some of the pitfalls that Dr. Harris has touched upon, is that reading a pill cam is very time consuming. It takes about like the mean reading time, especially like at the beginning, like the diagnosis is like 40 to 60 minutes, but the majority of the time is actually trying to find the history, looking at the patient's medical history and trying to find the reason and looking at their medications and what diagnostic tests that they had before and afterwards actually finalizing the report is the one that takes time, even for the experienced ones. So there is a reader fatigue, how many can you read in a day, especially when you have an, when your institution allocates a time, so how many can you read it? It is not recommended generally because there is also like a reader fatigue, so there is no clear number that is out there that it is better to read like two or three or four versus five or six, but we need to consider the reader fatigue also. Then the main thing also is that reader competency, as Dr. Kaif has kind of said in his talk previously, the European society has set some training standards to kind of determine the competency of the reader. So do you view it in a single frame or a dual frame or a multi-frame? Generally, the dual frame or the four card view is recommended. And what is the maximum speed? Like if you're in a single frame, then it should not be more than 15 images per second. And if it's a dual frame or a quad frame, no more than 20, because anything more than 20 is associated with an increased risk of miscellanies. So what are the strategies to kind of mitigate that interpretation challenges? Is that some of them, the AI-assisted softwares, they can remove the duplicate images and also reduce the reading time. But even with the AI software and everything, if you use a single frame lesion, I think there is increased risk of missing lesions, especially in the proximal small bowel. So generally single frame lesion is not recommended. And how about like, I'm sorry, the automated software algorithms, not the AI ones, that are available now. So what is the, so right now, there's a lot of interest, everything is in AI. So AI-assisted reading of the studies has decreased the reading time significantly, like 3.8 minutes versus 30 minutes. So we have to see how AI can work and help us better manage interpretation of the capsules and also add to the quality of life of the doctors. So coming to the reader competency, what are the minimum number of capsule procedures that one has to read before they become good at it? It is generally between from like 20 studies to like 30 to 50 studies. And ESG has recommended a formal curriculum for competency, you know, like a structured core curriculum that involves a direct observation and also supervised observation too. And coming to the mimickers and the over-diagnosis, you know, they also kind of contribute to the pitfalls of the pill can. And some of the common ones are, you know, when people take a lot of non-steroidals and they don't stop it, like before the pill came or even like having a cancer like lymphoma. And sometimes, you know, what we have seen is that get referrals for having like a double bone endoscopy because, you know, they suspected the patients having small bowel Crohn's disease because it's kind of subtle, it's not very clear, but as it was previously said, if there are no increased, if the inflammatory markers were normal and, you know, the yield of finding or even like finding, like having the Crohn's disease in small intestine is like really low. So the pretest probability will be low. Then there is Lewis code that is embedded in the pill cam software itself, where you can easily differentiate between what is a significant inflammation versus a non-significant inflammation and also can categorize to the degree of inflammation. So this is just a slide kind of telling the score just for the readers and everything. If the score is more than 135, then the oral diagnostic accuracy of a significant lesion is high. Another pitfall is the mislabeling the findings and also missing, you know, high misrates of significant findings. So the pylorus, as we go, like it can come in the retrograde view and it can show the Brenner's gland in the duodenal bulb. And those things can be misinterpreted as not having like a polypoid mass. And sometimes, you know, ampullar water, better like that, that can also be misrepresented as a polyp. So the readers should be kind, readers should be very experienced in identifying the normal findings, you know, both of the normals, submucosal bulges, the lymphangiectasius and the phlebactasius. So the misrate of lesions is high in the proximal small bowel, especially for the malignancies. Possibly, you know, the reason behind that, the hypothesis is that when you have a large mass near the ligament of trite, it kind of stretches the fold, like if it's behind the fold and it can stretch it so the pill can will just kind of, you know, look in the forward direction rather than in the sidewards direction. So the misrate of other lesions, such as vascular lesions of ulcers, it is low, but it's still kind of, you know, 0.5 to 6%. So when you have like a submucosal bulge versus a tumor, right? How do you differentiate that? You know, when you're reading a pill cam and you're looking at it and all of a sudden you see a little bulge and then you go back and then look at the frames and you kind of think about, okay, you know, is this something significant? You know, what should I do with this? The prevalence of small bowel tumors is about like 1.3%. And then I said that the misrate, if they're present in the proximal jejunum is high, but you can look at some features, you know, that can raise the alarm and say that, okay, this is not a normal or a benign lesion. So you have to look at for the change in the villus pattern and if there is any ulcers or any amplications or if the mucosa is stretched or if they have like a thickened folds. But having said that, you know, about half of the small bowel tumors, you know, they don't have this alarm signs. You know, they may just have like a smooth running, protruding lesion. And that may be, so that's hard to kind of say whether that's a benign submucosal bulge versus a tumor. So there is a criteria that has been developed, you know, to kind of determine whether a bulge, submucosal bulge is benign versus tumor. So the SPICE criteria. So this is basically takes into four things into consideration. It is the borders of the lesion and also the ratio between the diameter and the height of the lesion. And the third thing is that is a lumen visible in these frames. And the fourth one is, does the same image last for more than 10 minutes? So if more than there are two criteria for that, then is a high likelihood of submucosal lesion being something more significant than a benign bulge. Another thing is that if the mucosal angle is more than 90 degrees there, it may represent a benign bulge versus a significant tumor. So this slide, it kind of, you know, shows the characteristics of the submucosal bulges based on the SPICE criteria. So the first one where you can see that is like ill-defined border with the surrounding mucosa and the diameter is larger than the height and you cannot see the lumen. So this is just kind of a fold, you know. So this can be categorized as like a SPICE zero to one. And the second one is where the surrounding mucosa is sharper and the diameter is larger, but the lumen is still not visible. And when you come to the significant lesions, and now you see the protrusion with the sharp edge. So this does not have like ill-defined borders. Now you can clearly see the borders and the diameter is shorter than the height and the lumen is not visible. And in the most significant ones is that they have sharp borders, the surrounding mucosa, the diameter is shorter and you can see the lumen. So these are the ones that has to, then we have to think about, okay, this is not like a benign one and it may be a tumor. So moving on to the complications, talk about perforation. So perforation is kind of rare and due to capsule retention but they're having cases about that. And the risk is higher in patients with like a severe Crohn's disease, like structuring Crohn's disease or they have a lot of adhesions. So the theory behind how a retained capsule can cause perforation is that when there is underlying mucosa that is already inflamed and the capsule kind of sits at that place for a long time, it kind of causes stretching and fissuring and kind of decreases a mucosal integrity and then merely to perforation. So other complication is the aspiration, very, very rare, but can happen. But the one thing is that, you know, like it can be asymptomatic and it is important to kind of select your patients who are at high risk for aspirations. You know, the risk factors are patients with obviously with thoropharyngeal dysphagia or they have a zincus-riveticulum or if they have esophageal dysmodility problems or a prolonged gastric transit time. And obviously, you know, patients with altered mental status, they are at a high risk for aspiration. So if a capsule has been aspirated, then we have to call our pulmonary colleagues, you know, to take it out via the Rothnat. Capsule interference, you know, with implantable cardiac devices, as we have said before, it is safe to use, you know, with a pacemaker, with the ICD and the LVAD. So LVAD, you know, it was said before, LVAD can interfere with the capture of the images of the pill cam, so you may lose some of the images. So the risk is like, so they have a good safety profile, so they can be safe to use with implantable cardiac devices. And so when a capsule gets retained, like when a capsule retention, that's one of the complications. So what do you do, right? So the pool prevalence is about 1.4 to 2.5%, and then it is higher in patients who have non-Crohn's disease. So capsule retention is defined as when the capsule is present in the intestine for more than two weeks, and the risk factors are if they have previous small bowel resection, or they had like abdominal or pelvic radiation therapy, or they have been using a lot of non-steroidals that are causing like NSAID strictures. Those kinds of things can do that, or if they have like Crohn's disease. So even though it has been, the previous studies have said that the capsule retention rate is 2.5%, the poor one, but careful patient selection, and also now using patency capsule as a preemptive test before has decreased retention rates. So this is a study that had looked at the capsule endoscopy procedures over a period of 20 years almost, and the pool retention rate in the study was 0.7%. And obviously the common cause of retention were the patients that have had Crohn's disease. And in those patients who had the retention, about half of them had to have surgery to remove the capsule, and about like 25% of them had a balloon asymptomy, had a balloon-assisted, device-assisted endoscopy to remove it. But if you look into that, about like 23%, you know, like there was no intervention done because they were asymptomatic. So as I said, the capsule retention, the most of the cases can be asymptomatic. So if the capsule has retained in a patient with the Crohn's disease, so you can use a trial of steroids, you know, to see that the inflammation has gone down. And if the capsule can pass spontaneously, and obviously like if that doesn't happen, then it has to be removed by device-assisted endoscopy. So what do you do to mitigate the capsule retention? And again, you know, careful patient selection, identifying who will be at risk. And so using cross-sectional imaging with like CT entrography or MR entrography to determine the disease activity, you know, like if they have like any strictures, the degree of inflammation. But, you know, there's a caveat up here, though. The unstrictures may be missed with a CT entrography or a MR entrography. So even that's normally the patient has had significant non-steroidal history, then there may be increased risk of capsule getting retained. So in those cases, you can use a patency capsule. Obviously the patency capsule, it is dissolvable. It dissolves after 30 hours, and it rules out, you know, the small bowel obstruction in almost majority, like 99%, but there are still, it doesn't exclude, there are still some case reports here and there where the patency capsule caused like an obstruction. But, you know, it kind of adds to the overall cost of the procedure. If there's a concern that the patient, you know, you have to get like abdominal imaging after the patient was given the patency capsule, with a KUB or maybe a SWAT CT scan. So when to use endoscopy for capsule placement? These are the indications, you know, children more than two years, if they have suspected or established non-obstructive swallowing disorder, or if they have increased risk for gastric retention that they're using narcotics or gastroparesis. I want to do as a panelist too, like if they have considered endoscopic deployment of capsules in patients having large hiatal hernias. So when I say large, is it like, you know, more than five to six centimeters. Do you use endoscopy to deploy the capsule if they had prior incomplete study? And obviously, you know, bed-bore patients who cannot walk around, so that they are at increased risk for gastric retention. So what is the role of device-assisted endoscopy? I'll touch briefly on that. It can be used to retrieve the retained capsule, it can be therapeutic in treating the lesions, and it also used for histological confirmation to aid in the diagnosis. So when there is an abnormal capsule study, then that requires a device-assisted endoscopy, then what approach do you use, right? So do you use an undergrowth approach or do you use a retrograde approach? So because there are no landmarks like in the study that we can say, oh yeah, we are in the proximal jejunum, we're in the mid-jejunum or distal jejunum or the ileum. So generally kind of it is considered that if the lesions are identified within the first 60% two-thirds of the small bowel transit time, then it's better to use like an anti-grade approach. But if you see a lesion like during the more than 60%, then you have to use retrograde approach for that. So to summarize, you know, what are the strategies to minimize pitfalls and complications? The most important thing is that appropriate patient selection with a detailed history, and also to kind of, you know, getting an informed consent from the patients explaining about the risk of retention and using the capsule endoscopes with a longer battery life and doing a risk assessment for capsule retention. And in that case with a CT entrography or MR imaging when using a patency capsule test and in hospitalized patients with bleeding, doing the capsule study within 48 hours and in outpatient setting like within two weeks, increases the diagnostic yield and deploying the capsule endoscopically if they are at high risk for aspiration or gastric retention and also having a good competency in recognizing the normal and the abnormal findings. So when you're doing that interpretation, you using the view speed less than 20 frames per second. When you're examining the proximal small bowel, you can use even, you can use like a slower rate, you know, because there is increased risk of missing lesions in the proximal small bowel and, you know, can consider the real-time viewing with prokinetics if there is a high risk for gastric retention or if the patient has had like a prior incomplete studies. And it is also important to get an imaging study at two weeks or more, if there is any concern that the capsule has not reached the C-cum. So with this thing and thank you for your attention.

capsule endoscopy

PILCAM

small intestine diagnosis

complications

battery life

interpretation challenges

AI in healthcare