Early in July, the 6th annual NOSCAR sponsored Conference on NOTES was held in Chicago near O’Hare airport. I thought now would be the perfect opportunity to update you on the current status of the journey – what’s been accomplished, where are we now, where might we be going. The Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) was launched in 2005 through the vision of SAGES and ASGE past presidents David Rattner and Robert Hawes, as a dual-society collaboration to explore the feasibility, safety and challenges associated with translumenal surgery. Our collective imaginations were sparked by the preclinical work of Tony Kalloo and Sergei Kansevoy at The Johns Hopkins Hospital and the trans-gastric appendectomy performed by Rao and Reddy in India using off the shelf flexible endoscopic tools. How would this be developed? Would we repeat the frenzy (good and bad) of laparoscopy of the late 80’s and early 90’s? NOSCAR was formed as a SAGES/ASGE collaboration to responsibly guide the introduction of these techniques. I remember that first NOTES conference in Arizona. The excitement was palpable. How were we going to accomplish safe and reliable gastric closure? Would we finally realize the dream of scarless and painless cholecystectomies and appendectomies? What new tools would be developed? The first white paper charted the initial course for a prudent physician-led introduction of NOTES. In the first few years the NOSCAR Joint Committee raised 2.65 million dollars for competitive basic research. Grants were reviewed and awarded by the research committee independent of the funding source. NOTES societies sprang up around the world often modeled after the NOSCAR. A few years later, around the world the first clinical cholecystectomies appeared using trans-gastric and trans-vaginal (I didn’t see that coming) approaches. The feeling then was that all NOTES cases should be done on protocol and small series emerged demonstrated feasibility of the NOTES techniques to the point where we decided that a prospective clinical trial could be organized comparing NOTES cholecystectomy to standard laparoscopic cholecystectomy. This is underway.
Ten Accomplishments as a result of SAGES and ASGE forming NOSCAR.
- A valuable and durable relationship between SAGES and ASGE which has opened a heretofore unseen dialogue between GI and Surgical colleagues at a national and international level. As a result there is also opportunity to work jointly on a panoply of non-NOTES but still communal issues such reimbursement, training, research and education.
- An outpouring of tool development that will benefit laparoscopic or endoscopic procedures regardless of the success or failure of NOTES as a technique.
- A re-energizing of the commitment to furthering the march toward reducing pain or improving cosmesis. The explosion of single port procedures can be attributed to this journey. The multiple reports of single port procedures were largely ignored for years until the formation of NOSCAR.
- The engagement of industry to work in a previously unseen collaborative fashion to fund first the basic research grants and then the human clinical trial. Companies providing funding for cases where competitors products might be employed at least borders on the altruistic since it has never happened before. NOSCAR seeks to discover in a prospective fashion information concerning the safety and efficacy of NOTES as a generic platform. Five competitors (alphabetic) Covidien, Ethicon Endosurgery, Olympus, Karl Storz and Stryker have jointly contributed funding NOSCAR research in an arm’s length fashion allowing the consortium total control of grant awards.
- The interest in NOTES has fostered development and human application of the POEM (per oral endoscopic myotomy) procedure for the totally endoscopic treatment of achalasia. This may very well become the standard of care for this disease in the near future.
- The development of a transrectal NOTES procedure for the treatment of rectal cancer has been fostered by the NOSCAR basic research grants and now is in clinical trial.
- Six international meetings, two white papers and more the 600 PubMed citations since 2005.
- The initiation of the Human Clinical Trial for NOTES versus laparoscopic cholecystectomy conducted as a Society as Investigator Trial by NOSCAR. More than 30 patients have already been enrolled at Baystate, Yale, Oregon Clinic, Northwestern, UCSD hospitals with several more sites about to join.
- The international engagement of surgeons on many continents to initiate their own NOTES development including the creation of many NOTES collaboration groups modeled after NOSCAR. Thousands of NOTES cases have been performed worldwide.
- The recognition that concepts that we thought were sacred need constant re-evaluation.
This year’s NOTES conference audience was polled: What percent of cholecystectomies will be performed via a natural orifice approach in 2020? As you might expect opinions varied, but no one (admittedly the group is biased) thought NOTES would be a historical footnote gone the way of gallstone lithotripsy.
Regardless of the future for NOTES, the creativity and imagination of surgeons around the world has been captured in a fashion similar to the early days of laparoscopy. Our surgical lives are not destinations; they are truly journeys. NOTES and the NOSCAR consortium embody the value of such an adventure. Most importantly, it has been traveled with great care and the foremost concern for the welfare of our patients.
If you have ideas, questions or concerns about SAGES or the future of surgery, please write me at [email protected]
Steve Schwaitzberg, MD