title: Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial.
abstract: BACKGROUND
  Natural-orifice translumenal endoscopic surgery (NOTES) is a possible advancement for surgical interventions. We initiated a pilot study in humans to investigate feasibility and develop the techniques and technology necessary for NOTES. Reported herein is the first human clinical trial of NOTES, performing transoral transgastric diagnostic peritoneoscopy.
  
  
  METHODS
  Patients were scheduled to undergo diagnostic laparoscopic evaluation of a pancreatic mass. The findings of traditional laparoscopy were recorded by anatomical abdominal quadrant. A second surgeon, blinded to the laparoscopic findings, performed transgastric peritoneoscopy. Diagnostic findings between the two methods were compared and operative times and clinical course were recorded. Definitive care was based on findings at diagnostic laparoscopy.
  
  
  RESULTS
  Ten patients completed the protocol with an average age of 67.6 years. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic endoscopic peritoneoscopy. The average time of diagnostic laparoscopy was 12.3 minutes compared to 24.8 minutes for the transgastric route. Transgastric abdominal exploration corroborated the decision to proceed to open exploration made during traditional laparoscopic exploration in 9 of 10 patients. Peritoneal or liver biopsies were obtained in four patients by traditional laparoscopy and in one patient by the transgastric access route. Findings were confirmed by laparotomy in nine patients. Eight patients underwent pancreaticoduodenectomy and two underwent palliative gastrojejunostomy and/or hepaticojejunostomy.
  
  
  CONCLUSIONS
  Transgastric diagnostic peritoneoscopy is safe and feasible. This study demonstrates the initial steps of NOTES in humans, providing a potential platform for incisionless surgery. Technical issues, including instrumentation, visualization, intra-abdominal manipulation, and gastric closure need further development.
authors: Division of General Surgery, The Ohio State University Medical Center, Columbus, OH, USA. jeffrey.hazey@osumc.edu
authors: Jeffrey W
authors: JW
authors: Hazey
authors: Vimal K
authors: VK
authors: Narula
authors: David B
authors: DB
authors: Renton
authors: Kevin M
authors: KM
authors: Reavis
authors: Christopher M
authors: CM
authors: Paul
authors: Kristen E
authors: KE
authors: Hinshaw
authors: Peter
authors: P
authors: Muscarella
authors: E Christopher
authors: EC
authors: Ellison
authors: W Scott
authors: WS
authors: Melvin
mesh_terms: D000368:Aged; D016145:Endoscopy, Digestive System / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D009055:Mouth; D009367:Neoplasm Staging; D010149:Postoperative Pain / Q000503:physiopathology; D010190:Pancreatic Neoplasms / Q000175:diagnosis* / Q000601:surgery*; D010865:Pilot Projects; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D013270:Stomach; D016896:Treatment Outcome
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