OBJECTIVE(S): We validated Natural Orifice Translumenal Endoscopic Surgery (NOTES) in a human trial of ten patients undergoing diagnostic transgastric endoscopic peritoneoscopy (DTEP) for staging of pancreatic head masses. Reported herein is an update with 10 additional patients.
METHODS: Patients in this IRB approved human trial were scheduled to undergo diagnostic laparoscopy for abdominal staging of a pancreatic mass. Findings of traditional laparoscopic exploration were compared to that of transgastric endoscopic peritoneoscopy (TEP). A second surgeon, blinded to the laparoscopic findings, performed TEP using a therapeutic gastroscope. Diagnostic findings, operative times and clinical course were recorded in 20 patients and compared to findings at staging laparoscopy. Definitive care was rendered based on the findings at laparoscopy.
RESULTS: Twenty patients underwent diagnostic laparoscopy followed by successful DTEP under laparoscopic guidance. The average time for completion of diagnostic laparoscopy was 10 minutes compared to 21 for the transgastric route. Experience acquired during the initial 10 procedures equated to a 7.4 minute decrease in TEP time in the second 10 cases. DTEP corroborated laparoscopic findings for surgical decision making in 19 of 20 patients (95%). Peritoneal or liver biopsies were obtained in three patients by traditional laparoscopy, and one by transgastric endoscopy. Eighteen patients underwent a pancreaticoduodenectomy. Two palliative gastrojejunostomies were performed. There were no significant complications related to either the endoscopic or laparoscopic approach.
CONCLUSIONS: This study supports our previous conclusions that the transgastric approach to diagnostic peritoneoscopy is feasible, safe and accurate. Technical issues, including visualization, intra abdominal manipulation and gastric closure require further development. Investigation as multicenter trial without laparoscopic visualization with comparison to a historical cohort of staging laparoscopy is essential to validate this use of NOTES.
Session: Podium Presentation
Program Number: S083
« Return to SAGES 2009 abstract archive
