NASHVILLE, Tenn. ( Ivanhoe Newswire) - Sixteen thousand new cases of liver cancer are diagnosed each year. Surgery can help remove the tumors but it's risky and can lead to serious complications. Now a new technology is giving doctors directions to help kill a killer.
Richie Ruben has a passion for all things sports and he keeps it where he can see it. What he didn't see coming was liver cancer.
"I thought actually it was a gall bladder problem," Richie Ruben, told Ivanhoe.
It was a tumor. Surgery to remove it would be dangerous because of its location. So Doctor William Jarnigan of Memorial Sloan-Kettering used an organ positioning system. Similar to a GPS, the OPS uses cameras instead of satellites as guidance.
"It's pretty much like the GPS system in your car where you can actually see the road, the route you are taking," William R. Jarnagin, M.D., FACS, chief of hepatopancreatobiliary service and director of the hepatobiliary fellowship program at Memorial Sloan-Kettering Cancer Center, said.
Developed by engineers at Vanderbilt University the system uses an optical probe to safely enter the organ's surface.
"Turns out in the process of presenting a liver for surgery, you deform it, you change its shape from what it looks like pre-operably," Dr. Michael Miga, an associate professor of biomedical engineering and co-founder of the Vanderbilt Initiative in Surgery and Engineering (VISE), said.
The 3D model makes it easier for surgeons to target unhealthy tissue and steer clear of healthy tissues.
"It allowed us to place the probe precisely and deliver the energy that needed to be delivered to kill the tumor," Dr. Jarnagin said.
Richie was out of the hospital in two days and back to work in two weeks cancer free.
"I feel great," Richie said laughing.
The OPS is currently being tested in hospitals across the U.S. Doctor Miga said if it continues to be a success, the device could create a bigger safety margin allowing doctors to perform more aggressive surgeries with much less risk.
BACKGROUND: The percentage of Americans that develop liver cancer has been slowly rising for several decades. Liver cancer is more common in men than women, though it is rare in the US in both groups. More than 90 percent of people diagnosed with liver cancer are older than 45 years of age, and the average age for diagnosis is 63 years old. Around 3 percent are between 35 and 44 years old and less than 3 percent are younger than 35.
This cancer is substantially more common in countries in sub-Saharan Africa and Southeast Asia than in the United States. It is the most common type of cancer in many of these countries. Liver cancer is diagnosed in more than 700,000 people worldwide as a leading cause of cancer deaths, accounting for more than 600,000 deaths each year. (Source: www.cancer.org)
TYPES: Hepatocellular Carcinoma: most common type of liver cancer where cancer cells form in liver tissue. It affects an estimated 24,000 people in the US each year.
Cholangiocarcinoma (Bile Duct Cancer): a rare cancer which occurs in ducts that drain bile from the liver to the small intestine. Every year, 2,000 to 3,000 people are diagnosed in the US.
Liver Metastasis: Cancer that starts in another part of the body and spreads to the liver. The most common cancers to spread to the liver are colorectal cancers, gastrointestinal cancers, and melanoma. (Source: www.upmccancercenters.com)
TREATMENT: There are many different options to treat liver cancer, depending on what stage you are in. Treatment options include surgery to remove a portion of the liver, a liver transplant, freezing cancer cells, heating cancer cells, injecting alcohol into the tumor, injecting chemotherapy drugs into the liver, radiation therapy, and targeted drug therapy. (Source: www.mayoclinic.com)
NEW TECHNOLOGY: The goal of creating this system was to develop a laparoscopic method for three-dimensional localization of tissue and organ surfaces during minimally-invasive, image-guided surgery. It would hopefully bring the benefits of image-guided surgery to abdominal laparoscopic procedures. The system has the potential to track tissue movement in real time and to measure the shape of visible anatomic structures via rapid localization of large numbers of surface points. Localization can be performed at sufficiently high data rates to track tissue motion due to respiration, guide coregistration with preoperative anatomic image sets, and provide the constraints required by deformable tissue models. The system was designed around conventional laparoscopes so image guidance can be provided with very little change to normal clinical procedures. (Source: bmlweb.vuse.vanderbilt.edu)
Dr. Michael Miga, an Associate Professor of Biomedical Engineering Co-founder of the Vanderbilt initiative in Surgery and Engineering (ViSE), talks about a high-tech road map to help destroy tumors.
Why the GPS system for liver surgery?
Dr. Miga: Colorectal carcinoma is a common cancer. There are about a hundred forty thousand cases per year, and about half of those are going to metastasize to the liver. So, the need to resect tumors in the liver is a very important thing. It's also done with curative intent. That means, if you can resect the tumor and get rid of it clean you've cured the patient of liver cancer. It has that benefit. When you think about seventy thousand cases per year that's a lot of patients. This technology can really translate nationally and internationally. The types of things that we're doing are very reasonably affordable by a conventional hospital.
Is this something any surgeon could learn how to use?
Dr. Miga: That's one of the challenges with image guided liver surgery, it's not done right now. Image guided surgery has really only been in the brain. Now we're asking liver surgeons to take a piece of technology and invest some time in it and use it within the liver and see what it can do.
Why the liver after the brain?
Dr. Miga: If you look in the literature, there is evidence that aggressive liver surgery has better outcome. It's clear, studies have looked at less aggressive surgery versus aggressive surgery and have shown better five year survival rates with aggressive surgery. The ability to do aggressive surgery is a good thing if the patient can survive that initial surgery. What this technology is really focused at doing is making that surgery safer. While the idea is certainly to resect all the cancer, it is also about navigating a highly vascularized organ. There are a lot of blood vessels. What surgeons don't want to do is cut through a lot of blood vessels and create a lot of bleeding which may cause the patient to bleed out. What this system is good for is making safer surgeries for liver.
How does it work?
Dr. Miga: Essentially you have the ability to track all your instruments in relation to the organ, the liver itself. When the surgeon presents the liver for surgery they have all these nice tracked instruments. Now they have a TV monitor that can display the CT images of the liver. Now the Pathfinder technology allows you to touch the patient's organ with an instrument and determine where that is on the CT images. What you can now do is use the TV monitor to visualize what's underneath the surface, blood vessels as an example. Even though you can't see them when you're actually operating, the images allow you to navigate through the organ and get to the cancer and resect while avoiding major vessels so the patient will not bleed too much. There is a twist. It turns out in the process of presenting a liver for surgery the surgeon tends to deform it, you change its shape from what it looks like preoperatively. In addition, as you go through it during surgery, you can change its shape more, perhaps the cancer moves around and shifts a bit. In some of the new research, we're going to try to figure out a way to update those images, update that map to the cancer. The way we're doing that is with a computer model. We take data within the operating room about how the surface has changed. The data is limited but that's why the model is important. From the little bit of data, we can infer where everything in the organ has shifted to so the surgeon's map is improved. The process is not too intrusive to work flow so the surgeon is not overly delayed in performing the surgery. The bottom line is that this new technology is going to make that navigation path to the cancer more accurate.
Has it been FDA approved?
Dr. Miga: The process of doing image guided liver surgery without the deformation correction by the computer model has been FDA approved. You can get one today. The work began in the laboratories at Vanderbilt. It then was commercialized with Pathinder Therapeutics where it became FDA approved. It is now being tested at many different sites around the country. The NIH research award is taking it to the next phase, which is to make it even more accurate by correcting the shifting and changing shape that occurs during surgery.
How far along are you in the project right now?
Dr. Miga: We have a prototype of a correction system that's integrated in to the Pathfinder system that we are going to test with our clinical partner which is Memorial Sloan Kettering Cancer Center in New York City.
How much do you think this is going to change the way we see surgery for livers?
Dr. Miga: I think it will become commonplace. I think right now surgeons do things without the benefit of guidance other than perhaps using ultrasound and there understanding of the surgery learned over years of conducting surgeries. What we would like to be able to do, and I think we will be able to do, is increase the number of liver surgeries, and conduct them more safely. Specifically, right now it's a risky procedure and you've got to evaluate many different aspects when you want to conduct this procedure. Well, if you know that with a device like this you can be a bit more aggressive without losing any safety, you'll have more surgeons conducting surgeries. It's really about making more patients candidates for the surgery. In fact, if you look at the literature, you'll find some physicians prescribing chemotherapy to allow patients to become surgical candidates. They'll make the tumor shrink a little bit to make a patient a viable surgical candidate. What you hopefully will see is an elevated number of surgeries that will then go after these cancers. You'll have better patient outcomes, better five year survival rates, that's what you hope for.
What is it that is special about this effort?
Dr. Miga: A little over ten years ago the concept of image guided liver surgery began at Vanderbilt. In about five to seven years that had gone from testing in the lab to an FDA approved product. Now you're seeing it again, which is, we have a prototype for deformation correction that started out about five years ago and now it's getting ready to be deployed and clinically evaluated. Hopefully that will be approved very shortly too. One of the strengths of Vanderbilt is that we have an extremely good capability of translating work from the bench to the bedside. We have an extremely good collaboration between surgeons and engineers. Surgeons and engineers typically speak the same language. We're all about trying to improve the care of our patients. At Vanderbilt we have a very unique partnership with our surgeons so we sit in the same meetings, we discuss what is needed, we work the problems together. The speed at which we translate things is really remarkable. We're interested in helping the patients that walk through the doors today not twenty years from now or thirty years from now. All the research or a good portion of the research we're doing is really targeted at patient care today. If you get liver cancer, the kinds of technologies we're developing will help you in your lifetime not just your children or grandchildren.
What's next for this technology?
Dr. Miga: One of the things I think that's important to recognize is this work is sponsored by The National Institutes of Health and they've done that through a very interesting mechanism. They call it an academic industrial partnership. For our grant, our award, we have three partners. The Vanderbilt team and what we're doing is a lot of the research and development towards this idea of correction and image guided liver surgery. What Pathfinder Therapeutics is doing, our industrial partner, led by Dr. Jim Stefansic, is really in charge of the integration and the ability really to disseminate this technology. The third partner of this team is our clinical partner that's independent of us so we can get a really credible assessment. That's being headed by our clinical collaborator Dr. William Jarnagin of Memorial Sloan Kettering Cancer Center in New York. The data we are getting from them is the sense of how the technology performed? How well did it work? And we're updating our designs and changing our methods to accommodate the real surgical work flow.
If this goes well and it gets approved, what other parts of the body should we expect medicine and technology to merge?
Dr. Miga: We have work going on in kidney surgery; we have work going in orbital surgery which you wouldn't think, cochlear implants. We have robotic work that's looking at applications in otolaryngology, and cardiology. There is also work directed towards breast surgery.
Can you give me a number of how many people this is going to help?
Dr. Miga: When you normally work up for a surgical procedure, the amount of diagnostic information can be extensive. There can be a mountain of data available prior to a procedure. Why not use this data in the operating room to help make decisions, it only makes sense. I believe you're going to see this idea of translating all the information you can to address the patient in the operating room as a continuous development helping patients more and more in the future. In time, I believe almost every patient that goes into surgery will experience guided interventions in the future.
What makes you excited about working on a project like this?
Dr. Miga: The late Steve Jobs talked about doing things that you love because it makes the job fun. When you have the surgeons, the industrial partners, and the researchers all caring about patient outcome, when it is the one thing that makes them all go in in the morning, that's a fundamental game changer in terms of the way we do things. It makes it fun!
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