title: Diagnostic transgastric endoscopic peritoneoscopy: extension of the initial human trial for staging of pancreatic head masses.
abstract: BACKGROUND
  The validity of natural orifice transluminal endoscopic surgery (NOTES) was confirmed in a human trial of 10 patients undergoing diagnostic transgastric endoscopic peritoneoscopy (DTEP) for staging of pancreatic head masses. This report is an update with 10 additional patients in the series and includes bacterial contamination data.
  
  
  METHODS
  The patients in this human trial were scheduled to undergo diagnostic laparoscopy for abdominal staging of a pancreatic head mass. A second surgeon, blinded to the laparoscopic findings, performed a transgastric endoscopic peritoneoscopy (TEP). The findings of laparoscopic exploration were compared with that those of the TEP. Diagnostic findings, operative times, and clinical course were recorded. Bacterial contamination data were collected for the second cohort of 10 patients. Bacterial samples were collected from the scope before use and the abdominal cavity before and after creation of the gastrotomy. Samples were assessed for bacterial counts and species identification. Definitive care was rendered based on the findings from laparoscopy.
  
  
  RESULTS
  In this study, 20 patients underwent diagnostic laparoscopy followed by DTEP. The average time for completion of diagnostic laparoscopy was 10 min compared with 21 min for TEP. The experience acquired during the initial 10 procedures translated to a 7-min decrease in TEP time for the second 10 cases. For 19 of the 20 patients, DTEP corroborated laparoscopic findings for surgical decision making. One endoscopic and five laparoscopic biopsies were performed. Pancreaticoduodenectomy was performed for 14 patients and palliative gastrojejunostomy for 6 patients. No cross-contamination of the peritoneum or infectious complications were noted. No significant complications related to either the endoscopic or laparoscopic approach occurred.
  
  
  CONCLUSIONS
  This study supports the authors' previous conclusions that the transgastric approach to diagnostic peritoneoscopy is feasible, safe, and accurate. The lack of documented bacterial contamination further supports the use of this technique. Technical issues, including intraabdominal manipulation and gastric closure, require further investigation.
authors.affiliation: Division of General Surgery, The Ohio State University School of Medicine and Public Health, 410 West 10th Avenue, Columbus, OH 43210-1228, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Nau
authors.forename: Joel
authors.initials: J
authors.lastname: Anderson
authors.forename: Benjamin
authors.initials: B
authors.lastname: Yuh
authors.forename: Peter
authors.initials: P
authors.lastname: Muscarella
authors.forename: E
authors.initials: E
authors.lastname: Christopher Ellison
authors.forename: Lynn
authors.initials: L
authors.lastname: Happel
authors.forename: Vimal K
authors.initials: VK
authors.lastname: Narula
authors.forename: W Scott
authors.initials: WS
authors.lastname: Melvin
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Hazey
mesh_terms: D000368:Aged; D001706:Biopsy / Q000379:methods; D003937:Diagnosis, Differential; D020776:Endoscopes, Gastrointestinal; D005240:Feasibility Studies; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods*; D010179:Pancreas / Q000473:pathology*; D010180:Pancreatectomy / Q000379:methods; D010190:Pancreatic Neoplasms / Q000175:diagnosis* / Q000601:surgery; D015203:Reproducibility of Results