Costs remain a significant problem. Those of you who are golfers who put titanium in your woods to hit the ball farther know that’s a very expensive metal. So some of these stents using nitinol and other compounds, the cost is still very high and that’s a major concern when we look at cost effectiveness. Our group last spring presented some information. This was a randomized study, a small number of patients, but we tried to really get to this issue of cost and cost effectiveness. Comparing patients who only received laser photoablation therapy to stent placement. Again, this was the Schneider Wallstent that was used. Again, a small number of patients but effectiveness was about the same, but the patients in the stent group had fewer initial treatment sessions, fewer need for re-interventional sessions, and total endoscopic sessions overall were much less than the patients in the laser group. If you look at the cost – although the stent itself was $1,700 or so – overall the cost to the patient in their remaining lifetime was much higher for those patients who received laser therapy than for stent therapy. So our conclusions were that it’s a more cost-effective form of therapy for patiens for palliative care.

One point to keep in mind, those patients who have a tracheoesophageal fistula, as seen here – a little small slit, or a much more significant opening here, we can almost see the lung parenchyma – what can you do? There are three stents on the market, the Wallstent, the Z stent and the Ultraflex which are covered and again the covering is designed to kind of fit against the esophageal wall and provide a barrier for secretions and other things. Actually the Ultraflex, as shown here, because it is so flexible it can nicely conform to the esophageal wall. It works well for tracheoesophageal fistulas, just to kind of serve as a good barrier.
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In summary, it’s important to keep in mind the characteristics of the tumor; is it exophytic? Is extrinsic compression present? What are your goals of palliative therapy? Is the patient going to undergo adjuvant therapy? If that’s the case, we usually don’t recommend placement of an expandable metal stent as hopefully with shrinkage of the tumor you wouldn’t want the stent to just to simply fall into the stomach. The expandable stents have certainly gained a strong hold in the 1990’s. Generally they are thought to be very safe. They are technically much easier to put in place, rather than the rigid devices. Their effect is immediate, and generally minimal follow-up is necessary for most patients. The main drawback is their cost, but as I mention, I think cost-effectiveness still weighs towards the stents. The ideal situation, what’s in the best interest of your patients, will certainly … if the endoscopist is comfortable and can offer the patient a complete spectrum of palliative techniques.
Esophageal Cancer

What are the complications? Well they are slowly going down as operators gain more experience, but most significantly perforations now are occurring at a less than 1% rate. Serious complications including major bleeding, sepsis, perforation, across the board are somewhere in that 2.5-3% range all together. One caveat to keep in mind, your patients who have already received radiation therapy, bleeding, perforations, other complications occur much more frequently in this sub-population of patients.

What about migration? When the stents were first produced, migration remained a significant problem but the companies have come up with little tricks. Flaring out the ends, putting barbed wires or little hooks on each end, hoping to keep the stents in place. This has been partially successful in reducing the rates of stent migration.

This is just showing the stent now in position. The guide-wire and delivery system is very carefully being removed, but you can see the annulated portion of the tumor in this region here with plenty of stent on each side. This device can actually be removed, or you can adjust this position after its placement. Keep in mind, be very careful when you remove the delivery system. It’s possible to snag on any of the stents and pull it out. This is just showing an endoscopic view of the lumen. This is an 18 mm diameter and the patient is now swallowing contrast material and you can see that pass through quite nicely off the distal end. So again, a successful placement.

A second video clip just showing the placement of Wilson-Cook Z stent. Again it comes in different sizes. It’s coded and it has flared ends on both sides. That’s hopefully to anchor the stent once it is positioned. The delivery system here is a bit different. More of the typical sheath retraction delivery system. But just watch. The tumor is located here and the upper margin is about there, but just watch as this stent is deployed there will be very minimal retraction. So fairly precise measurements can be made and hopefully you can maintain that precision when the stent is deployed. Here you can see the stent being slowly released as the sheath is being withdrawn, and you’ll see the delivery system and guide-wire have been carefully removed through the stent. This kind of device doesn’t quite have the radial force, as mentioned, of the EsophaCoil so you have to be very careful. It may not be fully opened for a minute or two. Always allow plenty of time for full deployment of the stent. In some situations you may actually want to go back down with the scope afterwards and carefully pass a TTS balloon to kind of aid in the full expansion of the stent. So here we are removing the guide-wire, you can look inside and if you think you need to, suggested by the radiographs, you may want to pass a TTS balloon and help the stent deploy a little bit further.

Those are two examples where things went pretty well. Does it always go that way? Of course not. This is called a “birds nest sign”. This is an EsophaCoil where the distal and proximal portions of the stent were beautifully released, and in the mid-portion unfortunately the whole thing just coiled up. Just kind of happened that way. Fortunately this can be taken care of. You can remove the EsophaCoil by grabbing the proximal end and just carefully removing the stent, and then a second was placed allowing for adequate lumen stenting.

How accepted are the stents right now? Well things really changed in 1993. This was the first randomized controlled trial comparing the plastic rigid-type stents to the … this was actually the Wallstent that was used, a randomized trial and following this the stents really gained a lot of acceptance and began to be used much more frequently. This study, as you will recall, isn’t a perfect study in that patients were kept in the hospital for a long time for the plastic stents, for dilation and general anesthesia and such, but the important take-home message is that the expandable metal stents were just as effective technically and functionally, but the complication was much less significant for the expandable metal stents. Perforations, pneumonias, migrations, didn’t occur in this limited study. And that’s really held true over the last six or seven years. Self-expanding stents require minimal pre-stent dilation. As I mentioned, the smaller caliber stents can be placed typically without any dilation whatsoever. The technical success across the board, looking at different series, between 90-100% – and most importantly – the functional success. The patient actually gets relief of dysphagia again at a very significant rate.

Finally, the last self-expanding stent is the Wilson-Cook Z stent. This is a stainless steel product with interlocking mesh triangles, again with a polyurethane coating to prevent tumor ingrowth. It comes in different sizes. One of the nice features of this stent is when it is deployed there is very minimal retraction. That is, when the stent pops in it doesn’t shrink down very much, so you can very accurately gauge the placement of this stent and that is really handy when you are placing a proximal esophageal stent where you are worried about respiratory compromise, and a few other applications as well.
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This table is in your syllabus but it kind of outlines some of the specs of the different stents. But keep in mind, the size of the delivery system is very important. If you have a large delivery system that is going to require a number of dilation maneuvers perhaps to place that, whereas if you have a very small delivery system, 18 French or 24 French, it’s quite easy to pop this in without even a single dilation maneuver. Four of the five stents are now covered, and that’s important for preventing tumor ingrowth and also for sealing tracheoesophageal fistulas. The radial force is quite different. If you’ve ever felt the EsophaCoil, it has kind of a firm, strong feel. Whereas the Ultraflex seems quite flimsy but they have different properties there. And again, degree of shortening is very important. I’ve mentioned the Z stent has very little shortening that occurs.

I’m going to show a little video tape again. The placement of a couple of stents. For those of you who haven’t been doing this much, just to show … first, the EsophaCoil. This is typical adenocarcinoma of the distal esophagus. It’s important to note where the tumor is so you have to mark the tumor margins both externally and internally. This is injecting radiocontrast, either lipid or water soluble. There’s already a mark distally. I think you can just see it, and now injection proximally into the margin of the tumor so you can gauge your stent placement. You have to size your stents. They come in different sizes, different diameters of course. We try to get at least 2-3 cm of stent beyond the proximal and distal margins in order to allow for the shrinkage which may occur. Once the stent is passed through the stricture area, the EsophaCoil has kind of a tricky delivery system. You have to release three different tabs. The first tab is the distal release, which releases the … kind of a string release device which allows the distal part to be released. And you turn the device and release the proximal portion of the stent. Again, you notice the shrinkage which occurs, a fairly significant amount. It kind of bunches up and then finally the middle part right across the stricture is released, which allows the full deployment of the stent and hopefully the coils are all fitting together nicely like they are supposed to. Again, keeping in mind that this is important when you gauge what size of stent you should put in. If you have a 6 cm tumor you probably want at least a 10 cm or 12 cm stent, especially when using a device like this.

What about rigid prostheses? Those of you who have passed a couple of the Celestin type or other rigid type tubes probably get a visceral response just looking at this slide. It’s a fairly uncomfortable procedure both for the endoscopist as well as the patient, but basically this is where a rigid plastic tube is shoved through the distal tumor with the use of a pusher-tube device. What’s the problem with this technique? Well, technically it’s difficult to perform. These tubes are big. The outside lumen is about 18, the outside of the diameter of the tube is typically 16-18 mm in size, so it requires fairly aggressive either single or serial dilatation maneuvers in order to allow the tube to be eventually advanced. Frequently general anesthesia is necessary for the patient to tolerate this procedure. Again, when you are pushing fairly vigorously with this device, or with the dilation maneuvers, perforation is a concern. Looking at all series, it averages about 10%. These are not small perforations. These are usually the big rips. The mortality per procedure, across the board for placing this type of tube, is about 2-4%. So it’s quite significant. Once these tubes are in position they don’t always stay there. The migration rate averages between 20-40%. They can pop proximally or distally as well. So again, migration and perforation, significant problems.

Laser photoablation is ideal for an exophytic, non-circumferential type of tumor. Again that fleshy type of tumor. And with a couple of laser sessions you can see that the tumor melts away, and with further efforts you can see the laser being fired. This is again with the YAG laser. You can create a pretty significant lumen. What are the downsides? Obviously it is expensive technology. It typically takes a couple of sessions at least to get the patient to this point where the lumen is a relatively decent patent size, and also downstream the tumors come back, the patients have to return. On average, patients who have laser photoablation therapy as their only endoscopic therapy average 4-5 endoscopic therapies during their remaining lifetime. So that’s one of the downsides as well.
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The new kids on the block are the self expanding metal stents. Brent showed us a picture earlier of their use in the biliary tract. They were first modified for esophageal use about 1991. This is an example of the Schneider Wallstent in place. The advantage of this type of device – obviously those of you who place it are quite aware of this – but it can be mounted onto a delivery catheter where it’s held in check with a sheath. When the sheath is withdrawn the stent is deployed, and then it provides a force against this esophageal tumor, hopefully providing a nice lumen such as seen here where the lumen is about 18 mm. There are now currently four commercially made stent devices. This is an example of the EsophaCoil, made by Medtronic. This is a nitinol device, nitinol alloy which is a combination of nickel and titanium. It is kind of a flat ribbon which has a nice memory feature, so the stent kind of recoils back to its original position after deployment. It has excellent radial force. It’s a nice stent to use in the distal esophagus, for example, when extrinsic compression is a concern. Once deployed, the coils are supposed to slide nicely and snug together hoping to prevent ingrowth of tumor. This is the Ultraflex device, both in the uncovered and covered. Again, a nitinol-type of compound metal. It has a very soft flexible feel to it so it’s a handy stent to use when there is a sharply angulated stricture. This is the Schneider Wallstent. The version on the right is the Wallstent I, which has a good radial force but the trouble was it was packaged into a 38 French catheter. Fairly stiff delivery system, which then allowed this stent to be deployed. Schneider has subsequently made the Wallstent II version which still provides a good lumen size, 18-19 mm lumen size, but this device is now packaged onto a 6 mm diameter catheter. So a very thin flexible catheter that can be placed much more easily and without the usual pre-dilation maneuvers compared to the old Wallstent version.

There are 10,000 cases of esophageal cancer per year in this country, and, unfortunately, most of those are un-resectable at time of presentation. The five-year survival was quite poor, and the life expectancy averages about six months in patients with un-resectable disease. Now as endoscopists, and physicians, our goal is to relive the most bothersome symptom for the patient, that is, the one that affects their quality of life most significantly, and that is dysphagia, and at the time providing nutritional access and also a means to prevent aspiration.

In the modern era it is important to at least consider now radiation therapy. There are special protocols designed to shrink tumors rapidly over a short period of time, such as over ten fractions, but importantly, the response rate is quite variable especially for the responses for adenocarcinomas. The time to see tumors shrink is also quite variable. It can take as long as six weeks, even in the responders, before you’ll get a significant effect – although the duration is usually around the time of five or six months where the benefit will be maintained. Importantly, stricture formation in patients who have radiation therapy can be a significant complication where endoscopic therapy is again called upon.

Since the advent of the fiberoptic endoscope, a number of interventional technologies have evolved, and listed here in the order in which they appeared. Dilation therapy, simply using a bougie or a balloon dilator is simple, quite easy to perform, but as you would imagine, the benefit is quite short-lived and typically, repeated dilatations are necessary. Aggressive dilatation can result in a dilatation in up to a quarter of the patients. Injection therapy is also quite simple, technically. You basically inject absolute alcohol or some other solutions into a kind of fleshy, soft, exophytic tumor where it works the best, and you may see some fluffage which occurs with that. But again, as you can imagine, with extensive fibrotic circumferential tumors this therapy doesn’t work very well.