BlueCross BlueShield of Tennessee Medical Policy Manual

Natural Orifice Transluminal Endoscopic Surgery

DESCRIPTION

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is being investigated as a less invasive surgical approach that combines endoscopy and surgery.  NOTES refer to the method of accessing the peritoneal cavity through a natural orifice (e.g., mouth, anus, and vagina) under endoscopic visualization.  As an example, NOTES may access the gallbladder by internal incision in the stomach and remove it though the mouth.    

Peroral endoscopic myotomy (POEM) is being investigated as a NOTES approach to Heller myotomy for treatment of esophageal achalasia.  A surgeon performs the myotomy by cutting only the inner, circular lower esophageal sphincter (LES) muscles through a submucosal tunnel created in the proximal esophageal mucosa.  Cutting the dysfunctional muscle fibers that prevent the LES from opening allows food to enter the stomach more easily.  POEM differs from laparoscopic surgery, which involves complete division of both circular and longitudinal LES muscle layers.  This procedure has the intent of reducing the total number of incisions needed and, thus, reducing the overall invasiveness of surgery.   Treatment options for esophageal achalasia traditionally include pharmacotherapy such as injections with botulinum toxin, pneumatic dilation, and laparoscopic Heller myotomy.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Well-designed studies in peer-reviewed journals that compare the natural orifice transluminal endoscopic surgery (NOTES) procedure to traditional surgery are not available.  Well-designed evidence based guidelines to address this technology from The Natural Orifice Surgery Consortium for Assessment and Research™ (NOSCAR®) are not available at this time.  Therefore, available evidence is insufficient to determine whether NOTES is at least as safe and beneficial as established surgical intervention/treatment. 

The literature on the efficacy of peroral endoscopic myotomy (POEM) as a NOTES approach for the treatment of esophageal achalasia primarily consists of small, case series and one non-randomized trial with historical controls. There are no controlled studies to determine the efficacy and safety above a control group, and there are no comparative effectiveness studies to evaluate long-term outcomes of POEM compared to alternative treatment (e.g., pharmacotherapy, pneumatic dilation). Therefore, it is not known if this technology is a safe and effective approach to the treatment of esophageal achalasia.

SOURCES

American Society of Gastrointestinal Endoscopy. (2008, May). Antibiotic prophylaxis for GI endoscopy. Retrieved October 10.2010 from http://www.guideline.gov/content.aspx?id=12809.

BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2013). Peroral endoscopic myotomy for treatment of esophageal achalasia (2.01.91). Retrieved October 15, 2013 from BlueWeb. (10 articles and/or guidelines reviewed)

Friedel, D., Modayil, R., Iqbal, S., Grendell, J. H., & Stavropoulos. (2013). Per-oral endoscopic myotomy for achalasia:  An American perspective. World Journal of Gastrointestinal Endoscopy, 5 (9), 420-427.

Inoue, H., Minami, H., Kobayashi, Y., Sato, Y., Kaga, M. Satodate, H., et al. (2010). Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy, 42 (4), 265-271.

Kurian, A. A., Dunst, C. M., Sharata, A., Bhayani, N. H., Reavis, K. M., & Swanstrom, L. L. (2013). Peroreal endoscopic esophageal myotomy:  Defining the learning curve. Gastrointestinal Endoscopy, 77 (5), 719-725.

Rattner, D. & Kalloo, A.; ASGE/SAGES Working Group. (2006). ASGE/SAGES working group on natural orifice transluminal endoscopic surgery white paper. Surgical Endoscopy, 22 (1), 329-333. (Level 5 Evidence)

Rattner, D. W., Hawes, R., Schwaitzberg, S., Kochman, M. & Swanstrom. L. (2011). The second SAGES/ASGE white paper on natural orifice transluminal endoscopic surgery: 5 years of progress. Surgical Endoscopy, 25 (8), 2441-2448.

U.S. Food and Drug Administration. (2007, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062875. Retrieved October 26, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062875.pdf.

U.S. Food and Drug Administration. (2009, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K092400. Retrieved March 17, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092400.pdf.

U.S. Food and Drug Administration. (2010, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082102. Retrieved October 7, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082102.pdf.

Vaezi, M. F., Pandolfino, J. A., & Vela, M. F. (2013). ACG clinical guideline:  Diagnosis and management of achalasia. American Journal of Gastroenterology, 108 (8), 1238-1249.

White, W., Haber, G., Doerr, M. & Getman, M., (2009) Natural orifice transluminal endoscopic surgery. Urologic Clinics of North America, 36 (2), 147-155. (Level 5 Evidence)

ORIGINAL EFFECTIVE DATE: 5/9/2009

MOST RECENT REVIEW DATE:  3/13/2014

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additional keyword(s): Transoral NOTES