Medical Device Daily Contributing Writer

LOS ANGELES – At last year's edition of Digestive Disease Week (DDW), it was called Per-oral or Transgastric endoscopy. This year it is Natural Orifice Translumenal Endoscopic Surgery – happily acronymed to NOTES.

But by either name it is the most talked-about new procedure – mostly, but not 100% in a positive way – at the '06 DDW meeting, a monstrous assembly of about 16,000 clinical, research and academic physician attendees and four medical associations: American Society for Gastrointestinal Endoscopy (Oak Brook, Illinois), American Gastroenterological Association (Bethesda, Maryland), Society for Surgery of the Alimentary Tract (Beverly, Massachusetts), and the American Association for the Study of Liver Diseases (Alexandria, Virginia).

Together, these diverse attendees are discussing how to advance research and turn “Science into Medicine,” this year's DDW title theme.

In the past 12 months NOTES has developed into a proactive research endeavor carried out by a collaborative group of surgeons, endoscopists, gastroenterologists, device manufacturers and other members of the four societies to pursue a “scarless” gastroenterology procedure.

The origin of NOTES is rumored this way: that “Miss India” had a ruptured appendix but insisted, “you cannot touch my skin.”

This prompted a surgeon to take an endoscope through her mouth, esophagus, stomach, making a small incision through her stomach, enter her peritoneal cavity, remove her appendix, and withdraw it back out through her mouth, suturing her stomach closed in the process of exiting.

Thus she was rescued from a life-threatening condition and without leaving a scar on her body.

While most believe this story to be a rumor, the first NOTES appendectomy performed on a human in fact was done in India, with most procedures being done in research labs. (See box for procedures done on humans and in animal research).

NOTES represents a model of cooperation between surgeons and gastroenterologists using a hybrid delivery system. While most surgeons have expertise using a rigid laparoscope inserted into the abdomen, and most gastroenterologists are comfortable with a flexible endoscope that follows a natural body tube, NOTES is a hybrid – a flexible yet somewhat rigid scope that can transmit force while incorporating multiple working channels in order to perform procedures within the peritoneal cavity.

Some industry experts are comparing NOTES to that of laparoscopic surgery of the '80s when the industry exploded with new techniques and devices that enabled surgeons to perform procedures that they had been doing in an open setting and now performing that same procedure through a laparoscope.

The first NOTES procedures began in a few labs in 2002 and, in an unprecedented event in the fall of 2005, this small, fragmented group of interested gastroenterologists and laparoscopic surgeons met in New York to discuss how best to proceed with this research, while at the same time making it safe and transparent for all interested parties.

Following that initial meeting, those interested parties were invited to participate in a symposium to discuss best ways to proceed – and more than 200 gastroenterologists, surgeons and manufacturers attended that meeting this past March in Phoenix.

Derived from that meeting was a list of directives that state the steps to be taken in going forward in pursuing NOTES research.

To that end, Lee Swanstrom, MD, of the Oregon Health Sciences University (Portland), presented “Development of a Platform for Transluminal Surgery” to a standing-room-only DDW crowd as he delivered the NOTES concepts, agreements and preliminary research. He described the goals and discussions from those first meetings of surgeons and endoscopists as being “a platform for a myriad of surgeries – not just a technique for specific procedures.”

He said “that what is direly needed, now that this group has determined how they are going to proceed with their research, is enabling platform technologies including those that can provide safe access through transesophageal, transcolonic and transvaginal routes.”

He continued: “we also need safe exiting of these hollow organs, tools for organ retraction, grasping, tissue approximation and an energy source that does not deliver collateral damage.”

In the meantime, these clinicians are using what is available, or adaptations thereof, in order to explore this new frontier.

As examples, he said that for scopes the R-Scope from Olympus (Hamburg, Germany), Shapelock from USGI Medical (San Clemente, California), and the endoscope from NeoGuide Medical Systems (Los Gatos, California) had been used.

Examples of tools they were using for closure were the Plicator from Ndo surgical (Mansfield Massachusetts) and the EndoCinch for closing the stomach from C.R. Bard (Murray Hill, New Jersey), and, for grasping tissue, the Eagle Claw from Apollo Medical .

Swanstrom stressed that “although they were using existing tools to advance the research, as they moved forward, they would need tools designed to optimize usability, be cost effective, and have patient safety in mind.”

Presenting a contrarian position concerning NOTES was Pankaj Jay Pasricha, MD, of the University of Texas (Galveston). He questioned the appropriateness of performing NOTES procedures, stating that there is “no great unmet need, the costs would not be cheaper” and asking the question: “Is having no visible scar really a reason to do this?”

Pasricha said he feels that NOTES needs to simplify complex procedures or enable physicians to perform procedures not currently being performed in order to be a viable platform for new technologies. He felt that the incremental improvement to laparoscopic procedures currently being performed would not be significant and that it would not justify pursuing this new frontier based on that alone.

However, he said he does consider the use of NOTES for addressing large populations of patients who currently can only be treated by medications. Should they be developed, these applications, he said, might include non-ulcerative dyspepsia, irritable bowel syndrome and morbid obesity, and are all worthy of further research.

In the final presentation of this symposium, Christopher Swain, MD, claimed “that just like laparoscopic surgery in the '80s, patients will want it.”

In addition to patient demand, he said that “the other driving force will be that NOTES allows access to areas that are less accessible to laparoscopy and that the stomach heals quicker than abdominal wounds and with less pain. There is also speculation that there could be fewer adhesions. The biggest barrier to this new frontier will be payment.”

One of the more compelling stories for NOTES procedures is that of bariatric surgery.

In the very obese, the fat layer creates a great distance between the surgeon and the operating field, even when using the extra long laparoscopic instruments created for bariatric surgery. The transgastric route for access to the peritoneum to perform the same RouxnY procedure simplifies the actual procedure significantly, making it an ideal procedure to be done using NOTES.

Swain then took a poll of the audience to determine its makeup and discovered that it was about 50% surgeons and 50% gastroenterologists, confirming the hypothesis that this is a hybrid specialty entailing both laparoscopic surgery and endoscopy.

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