Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial |
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Authors: | Jeffrey W Hazey Vimal K Narula David B Renton Kevin M Reavis Christopher M Paul Kristen E Hinshaw Peter Muscarella E Christopher Ellison W Scott Melvin |
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Institution: | (1) Division of General Surgery, The Ohio State University Medical Center, Columbus, OH, USA;(2) Department of Surgery Assistant Professor of Surgery, The Ohio State University Medical Center, N724 Doan Hall, 410 West 10th Avenue, Columbus, Ohio 43210-1228, USA |
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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. |
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Keywords: | Transgastric Surgery Endolumenal Surgery Natural Orifice Translumenal Endoscopic Surgery |
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