Endoscopic Innovations

Utilizing New Technologies in the GI Suite: A Case Study

As a nurse manager of a busy endoscopy unit, it can be very challenging for me to keep staff engaged in their work. It is always nice to see new technology come out, and it is also nice to have the ability to bring that technology into your endoscopy lab. Of course there are challenges such as budgetary restrictions and physician buy-in to the technology, but once you get past those two major stepping stones, you should be home free, right?

Not so fast.

You then need to find the staff members who are interested and up to the challenge of learning the new procedures involved with the technology. I am lucky enough to be working in a department that received the excellence in professionalism award from the SGNA last year. This group is always up for a challenge and willing to learn and grow.

The timing was right when we introduced SpyGlass™ and BARRX to our endoscopy lab for several reasons:

1. We needed to increase our number of procedures due to other outpatient endoscopy labs opening up in the area.

2. We had not introduced any new technology into the lab since adding our new manometry system to our department last year.

3. We needed to bring in revenue that the outpatient centers could not touch.

In the United States, nearly half a million people annually have an ERCP to diagnose problems in their liver, gallbladder and bile ducts. Physicians at Pitt County Memorial Hospital (PCMH) in Greenville, N.C., are now using a new cholangioscopy technology to diagnose and treat conditions such as obstructions and stones within the biliary tract. The device, known as the SpyGlass Direct Visualization System, provides physicians with a direct view of a patient’s bile ducts.

Conventional ERCP procedures performed with fluoroscopy and contrast injection are two-dimensional black and white images that often do not provide enough information to obtain a complete diagnosis, make it difficult to determine where to obtain tissue samples, and may potentially lead to an inconclusive clinical diagnosis. It is estimated that approximately 50 percent of ERCPs performed using brush cytology or biopsy forceps for tissue diagnosis result in inconclusive diagnosis. This has a negative influence on the appropriate and timely treatment of cancer and other serious diseases.

The SpyGlass System takes advantage of several technology advances such as the development of miniature probes with improved optical resolution, increased maneuverability and dedicated irrigation channels, as well as the development of miniature accessory devices such as biopsy forceps. It provides direct visual access into a patient’s biliary duct to improve diagnosis by helping to identify stones and strictures (obstructions). This system includes a miniature 6,000-pixel fiberoptic probe that attaches to the camera head. The probe is inserted through a single-use access and delivery catheter that can be steered in four directions to access and inspect all four quadrants of the treatment area. As a result, physicians are able to achieve an improved diagnosis for patients. Thus, unnecessary surgery may be avoided. Large and difficultto- extract bile duct stones can also be crushed using this system. There are many other potential applications, including early detection of cancer and in pancreatic diseases.

This technology is best suited for endoscopists with advanced ERCP skills. PCMH is one of only three centers in North Carolina that can provide this advanced technology.

Heartburn and acid reflux is a very common problem and affects almost one in every four people. Some patients with acid reflux experience chronic cough, chest pain or asthma instead of, or in association with, heartburn. As a result of chronic acid exposure to their esophagus, many patients develop a condition called Barrett’s esophagus, in which the inner lining of the esophagus changes from the usual squamous cell type to an abnormal intestinal type. It is estimated that approximately 3.3 million adult Americans have Barrett’s esophagus. Patients may be completely unaware of this change, as it does not cause any additional symptoms other than those due to acid reflux. However, this is a serious condition, as it significantly increases the risk of cancer of the esophagus (40 to 130 times greater than the general population).

The incidence of this particular type of cancer, called adenocarcinoma of the esophagus, has been increasing at an alarming rate over the past few decades. It fact, its rate of increase, 300 percent to 500 percent in the last 30 years, is the fastest compared to any other cancer. Once diagnosed, this cancer has a particularly poor prognosis, with a five-year survival rate of only 15 percent despite aggressive treatment.

The only way to diagnose Barrett’s esophagus is by performing endoscopy and biopsy. Once the diagnosis is made, these individuals need to undergo regular endoscopy and biopsy every one to three years with a view to detecting early cancerlike changes. This meticulous method of surveillance, while quite intensive, is not perfect and may not prevent all cancers due to Barrett’s esophagus. Patients’ quality of life is affected as they continue to worry about the possibility of cancer as they live with this precancerous condition. Once cancer-like changes are detected, surgical removal of the esophagus is generally recommended. This is a rather debilitating surgery with relatively high mortality.

The BÂRRX Medical HALO³⁶⁰ System uses radiofrequency to generate a localized area of heat for less than 1 second in the Barrett’s segment, which destroys the abnormal lining. Because the depth of penetration is only about 1 mm, patients do not feel any significant discomfort. Clinical studies have demonstrated that Barrett’s tissue can be completely eliminated with the HALO ablation technology in 98. percent of patients. For patients, this procedure is not much different than having a routine endoscopy and is done as an outpatient procedure without the need for hospitalization. Patients may experience some chest discomfort and mild swallowing difficulty for a few days after the procedure, but both can be easily managed. Follow-up endoscopies are scheduled in two to three months to assess response, and for additional treatment of residual Barrett’s tissue.

With the addition of these two exciting procedures to our endoscopy lab, we have generated renewed interest in learning amongst our staff. We have generated a new line of revenue for the hospital that the outpatient centers can’t touch right now. And, most importantly, we are helping our patients in ways that we have not been able to before. Having the ability to visualize the intrahepatic ducts and take targeted biopsies of tumors is just amazing. We watch these procedures and see the results of the BÂRRX treatments when the patients return. The patient’s esophagus looks normal, and the patients feel so much better. That is why we are in GI nursing, isn’t it?

Additional Tools

2007 has been a banner year for innovative products that make the healthcare worker’s job easier. Some tools are for direct use on patients, while others are intended to improve the provider’s knowledge.

For example, new tools are now being offered to improve nurses’ clinical and technical skills in endoscopy. The use of Immersion Medical Corporation’s surgical simulators in training programs has been shown to improve performance and to lead to shorter response time and less deviation from practice standards than non-simulator training.¹ Using a surgical simulator can increase trainee confidence and competence,² and many believe it helps improve patient safety, says Immersion’s public relations contact, Laura Cunningham.

Immersion has five comprehensive simulation platforms that allow users to emulate the look and feel of procedures. These platforms play an increasingly important role in medical training for complex, minimally invasive medical procedures.

But improving patient safety involves more than the surgeon’s technique. The Joint Commission (formerly The Joint Commission on Accreditation of Healthcare Organizations), has listed effective communication as No. 2 of the 2008 National Safety Goals.³

The Agency for Healthcare Research and Quality (AHRQ) has identified human factors, which include team training, as one means for bringing about a revised cultural mindset regarding medical errors.⁴

Medical simulators equipped with widely viewable monitors, realistic graphical renderings, and easy-to-access didactic content can be used to put surgical team members on the same page. Consider what could be learned by the surgical team if a physician had the luxury of explaining what he or she was doing, what he or she sees on the screen, where the scope is within the body, and how the team could or should respond given what was happening.

Teams that work together often have the opportunity to develop a familiarity and may have a better chance of improving the confidence and competence of each of its members, Cunningham says. “A simulated surgical experience can help establish familiarity among team members that might otherwise take years. Simulation team training, which may be especially valuable for understanding how to respond to complications, provides the luxury of a no-risk learning experience that allows teams to discuss each member’s role to improve response.

To use the simulator, the nurse would choose a training module, then review the training objectives and the didactic material. This might include indications and contraindications, an interactive 3D anatomy model, or videos and text about how the examination is performed.

In the bronchoscopy simulator, films of leading surgeons demonstrate how to hold, insert, operate, and navigate the bronchoscope, as well as how to anesthetize various points on the patient anatomy. In the bronchoscopy training, a user would then select the option to begin the case and wait for the prompt to insert the bronchoscope into the interface device. The screen then changes to an internal view of the body as would be seen through the bronchoscope.

The trainee may encounter complications that should be treated as well. Many metrics of the trainee’s performance are recorded and can be automatically stored. This report supplies immediate feedback for the trainee and can also be reviewed by program administrators to help customize training.

Other manufacturers have also produced invaluable improvements for endoscopy. Smith & Nephew offers a high-definition camera system, the 560 series, which is a surgical system designed to capture and display broadcast-quality images in arthroscopy and other minimally invasive surgical procedures.

Sony, too, offers high-resolution options — the PDW-70MD XDCAM HD recorder captures and stores up to two hours of highdefinition video of medical procedures, and is designed to store data for 50 years. Users can view thumbnail still-shots of footage, instead of manually forwarding or rewinding through hours of recording.

US Endoscopy continually improves its offerings for netted retrieval — now offering the Roth Net® Platinum™ series with a larger capacity, ergonomic design, and spring-like action. The tool can retrieve food impactions and polyp fragments, and has been designed with a deeper pouch to handle larger volumes of material.

Additionally, Olympus offers the Single Balloon Enteroscope System, which aims to improve efficiency during examination and treatment of the small bowel. Designed for use in either antegrade or retrograde fashion, and working with the EVIS EXERA II™ platform, the system offers high-resolution images and improved insertion ability. It can be used in concert with EndoTherapy devices for tissue sampling, hemostasis, and foreign object removal.

Endoscopic innovations don’t end with the peri-procedural tools — they also extend to the cleaning and reprocessing of these important devices. The new EvoTech™ endoscopic cleaner and reprocessor can be used to eliminate manual cleaning of endoscopes, freeing up time for technicians to use for other tasks. The reprocessor also provides automated leak testing, and aims to make cleaning and reprocessing techniques consistent by automating them as much as possible. Of course, precleaning is still required, but the EvoTech is designed to handle nearly everything else.

US Medical Systems offers the ENDO-VIEW SYSTEM, which is a fiberoptic video system that allows examinations of the biopsy channel of flexible endoscopes. Potential problems are identified before they become a major issue. The system is also designed to evaluate the cleaning process of the channel.

References:

1. Sedlack, Robert E. and Joseph C. Kolars. 2004. Computer Simulator Training Enhances the Competency of Gastroenterology Fellows at Colonoscopy: Results of a Pilot Study. American Journal of Gastroenterology. Jan; 99(1):38–9.
2. Wang, Tom, Ara Darzi, Rodney Foale, and Richard Schilling. 2001. Virtual Reality Permanent Pacing: Validation of a Novel Computerized Permanent Pacemaker Implantation Simulator. Journal of the American College of Cardiology (Supplement). 37(2): 493A–494A.
3. The Joint Commission. 2007. 2008 National Patient Safety Goals. http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/ Accessed Oct. 2, 2007.
4. The Joint Commission. 2007. Joint Commission International Center for Patient Safety: Chapter 4, Medical Team Training. http://www.ahrq.gov/qual/medteam/medteam4.htm Accessed Oct. 2, 2007.

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