This article is more than 5 years old. Information may no longer be current.

Transluminal Stents Represent the Next ‘Revolution’ in Therapeutic Endoscopy

Issue: April 2018

ByDouglas G. Adler, MD, FACG, AGAF, FASGE

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

For the past 30 years, rules 1, 2 and 3 of endoscopy were “Don’t perforate,” “Don’t perforate,” and “Don’t perforate.” These were the laws by which we lived until the idea arose to do procedures through the lumen by intentionally perforating the esophagus, stomach, bile duct and pancreas (among other locations) and going directly in through a perforation to conduct therapeutic maneuvers to treat the patient.

The idea is not brand new, but it’s only in the last couple years that it has really taken off. A decade ago, we were all talking about NOTES (natural orifice transluminal endoscopic surgery). That was a forerunner idea where you could perforate the stomach or bowel, enter the abdomen and perform a cholecystectomy or an appendectomy. Despite millions of dollars in research and some promising results, NOTES unfortunately did not receive widespread adoption, and, sadly, few are conducting NOTES research now.

Then, the technology changed. Late 2013, the FDA approved the first lumen apposing metal stent (LAMS), the first transluminal device commercially available in the United States. This stent on a catheter was designed for use through an endoscopic ultrasound scope to access and drain pancreatic pseudocysts and pancreatic necrosis.

Taking Off

Very quickly, LAMS underwent widespread adoption because it made what was previously a very cumbersome and time-consuming procedure – draining a pseudocyst or accessing pancreatic necrosis through the stomach or small bowel – a very appealing and quick procedure. LAMS created a more stable platform for gateway; the stent bridged the two organs and allowed easy traverse of that gateway on the index procedure and on subsequent procedures to perform debridement. Now, this once complex and cumbersome procedure that could easily consume an hour takes, without hyperbole, as little as 5 minutes.

Once people started doing these transluminal drainage procedures not just once or twice a year, but very frequently, they became easier, faster and physicians became much more facile and comfortable performing them. After people developed familiarity with pancreatic fluid collection drainage, they started looking for other transluminal targets.

For example, people like myself are now performing endoscopic gallbladder drainage. Under the NOTES dogma, we would have perforated the stomach (or other luminal organ), entered the abdomen and removed the gallbladder, which in practice proved extremely difficult and has not been widely adopted. A better solution for a poor surgical candidate is not to remove the gallbladder but simply to drain it internally. With a LAMS, you can connect the gallbladder to the stomach or the small bowel and drain it using the tools and techniques you’d use to drain pseudocysts on the gall bladder. Patients can have their gallbladders drained in a non-surgical manner. High-risk patients can avoid surgery entirely and they avoid a percutaneous drain in the gallbladder, which is deeply undesirable to many patients.

People have also looked at and developed techniques for transluminal access to drain the bile and pancreatic ducts in patients who are not candidates for standard ERCP given anatomic or post-surgical limitations. Some centers are currently using LAMS to create gastrojejunostomies in people who have, for example, gastric outlet obstruction from cancer. From early data, this appears to be really promising.

Another important use of these procedures is to conduct ERCP in patients who have had gastric bypass where normal route of the bile ducts has been made inaccessible. We can use transluminal procedures to go through the gastric pouch, enter the remnant stomach and re-access the small bowel so that ERCP can be done. This procedure is still relatively uncommon but is very promising.

The idea that’s common to all these procedures is violating a luminal intestinal wall – either the stomach or the small bowel or, rarely, the colon – doing everything we were taught not to do. We make a perforation and keep perforation open and use that perforation to access a different structure or organ to achieve another goal. It’s counterintuitive that a person could have a perforated stomach to their gallbladder or to their retroperitoneum and walk around and be just fine, but it turns out that it’s true.

Literature, Surgeons Following Suit

Although 2014 is recent, the number of papers on these procedures and their results has exploded. Obviously, the big target with transluminal procedures is drainage of pancreatic fluid collections such as pseudocysts and necrosis. For years, there was an ongoing debate regarding whether these patients go to surgery or to endoscopy. In the face of years of growing data where it looked like endoscopy was a better first-line therapy, people were still unsure.

Then, in December 2017, there was a well-done randomized clinical trial published in The Lancet. That study came down on the side of endoscopy as first-line therapy. This really changed the way many people see transluminal procedures given how the study was performed and the fact that it was published in such an influential journal.

All these things are happening in a short time. I’m not trying to be dramatic when I say revolution, but this is a sea change in our specialty.

By and large, surgery is a backup if we fail, although we often work on poor surgical candidates. Your goal with those patients is to typically have no surgical intervention ever.

We are working more with our surgeons to look at patients from a multidisciplinary perspective. We can typically decide as a group if a patient should receive surgery or endoscopy because people’s awareness and comfort with the transluminal approach is much higher than it was even 12 to 18 months ago.

Awareness Necessary

If you’re not a therapeutic endoscopist, you may never perform transluminal procedures, but you should be aware of them. For example, if a patient has a large pseudocyst, maybe they should be evaluated by GI first instead of a surgeon. If someone is turned down for cholecystectomy by surgery, maybe they shouldn’t go directly to a percutaneous cholecystostomy tube. Perhaps they should be evaluated by GI to see if they can have an internal tubeless drainage.

If you’re not doing these procedures, you should be aware so you can refer patients for the most modern and up-to-date treatment. If you are an advanced endoscopist and you want to learn these things, you can take courses and obtain hands-on training through the national associations.

I don’t want to over simplify. These are still high risk, complex interventions, but if you are comfortable doing ERCP and EUS, there’s no reason you can’t start to consider performing transluminal procedures if you are motivated and can accept that you’re treating very sick people. Even in the world of interventional endoscopy, not everyone is doing this and the bulk of the work is currently in tertiary care centers.

Outside of GI, many physicians have no knowledge of LAMS and think that a lot of these procedures can only be done by surgeons. It’s important for people to realize the world of endoscopy is changing and minimally invasive approaches for problems in pulmonary, GI, cardiology, vascular disease, etc., are being rapidly developed and implemented across medicine. There is a push to go the minimally invasive route because if you offer a patient surgery or any non-surgical alternative, they will almost always choose the non-surgical alternative.

On the cost front, LAMS are expensive although not all transluminal procedures use those stents. Overall, these procedures tend to be more expensive than regular endoscopy but whenever they’ve been considered from a cost-analysis basis, they’re almost always cheaper than surgery. That’s the lens through which we have to consider them.

Next Steps in the Revolution

More is coming. Medical device companies are very interested in these procedures. There is a lot of development. In the United States, we only have one transluminal stent, but in Europe and Asia, other LAMS have become available in the last 24 to 36 months.

We are going to see more and more FDA-approved devices either to perform transluminal procedures or accessories to assist these procedures. People are going to get more experienced development and progress in this area will only continue to move forward.

Our group and other groups are actively doing prospective and retrospective trials right now in the various procedures. There will be new data coming at DDW that we are eager to see and share.

Transluminal procedures are extremely gratifying, both for physicians and patients. You feel as if you’re doing something you’re not technically supposed to do, but we are doing it repeatedly and reliably and, in general, the patients do extremely well.

• References:
• Adler DG, Taylor LJ, et al. Endosc Ultrasound. 2017;doi:10.4103/eus.eus_4_17.
• Adler DG. Am J Gastroenterol. 2017;doi:10.1038/ajg.2016.566.
• Adler DG. Dig Dis Sci. 2018;doi:10.1007/s10620-018-5024-5.
• Adler DG. Gastrointest Endosc. 2017;doi:10.1016/j.gie.2017.03.1536.
• Adler DG. Lancet. 2018;doi:10.1016/S0140-6736(17)32344-9.
• Barbera C, Grande G, et al. Endoscopy. 2016;doi:10.1055/s-0042-111391.
• Binmoeller KF, Shah J. Endoscopy. 2011;doi:10.1055/s-0030-1256127. Epub 2011 Jan 24.
• Guo J, Saftoiu A, et al. Endosc Ultrasound. 2017;doi:10.4103/eus.eus_85_17.
• He WH, Zhu Y, et al. Surg Endosc. 2017;doi:10.1007/s00464-016-5324-9.
• Patil R, Ona MA, et al. Ann Gastroenterol. 2016;doi:10.20524/aog.2016.0008.
• Ryan BM, Venkatachalapathy SV, et al. Gut. 2017;doi:10.1136/gutjnl-2016-313388.
• Shah RJ, Shah JN, et al. Clin Gastroenterol Hepatol. 2015;doi:10.1016/j.cgh.2014.09.047.
• van Brunschot S, van Grinsven J, et al. Lancet. 2018;doi:10.1016/S0140-6736(17)32404-2.
• Venkatachalapathy SV, Bekkali N, et al. Endosc Int Open. 2018;doi:10.1055/s-0043-125362.

• For more information:
• Douglas G. Adler, MD, FACG, AGAF, FASGE, is Director of Therapeutic Endoscopy at the Utah School of Medicine. He can be reached at the Huntsman Cancer Institute, 2000 Circle of Hope, Salt Lake City, UT 84112; email: Douglas.Adler@hsc.utah.edu.

Disclosure: Adler reports he is a consultant for Boston Scientific.