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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References
Kantsevoy SV, Hu B, Jagannath SB, et al. (2006)Transgastric endoscopic splenectomy: is it possible? Surg Endosc 20(3):522–525
Kantsevoy SV, Jagannath SB, Niiyama H, et al. (2005) Endoscopic gastrojejunostomy with survival in a porcine model. Gastrointest Endosc 62(2):287–292
Bergstrom M, Ikeda K, Swain P, et al. (2006) Transgastric anastamosis by using flexible endoscopy in a porcine model (with video). Gastrointest Endosc 63(2):307–312
Park PO, Bergstrom M, Ikeda K, et al. (2005) Experimental studies of transgastric gallbladder surgery: cholecystectomy and cholecystogastric anastamosis (videos). Gastrointest Endosc 61(4):601–606
Wagh MS, Merrifield BF, Thompson CC. (2006) Survival studies after endoscopic transgastric oophrectomy and tubectomy in a porcine model. Gastrointest Endosc 63(3):473–478
Jagannath SB, Kantsevoy SV, Vaughn CA, et al. (2005) Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model. Gastrointest Endosc 61(3):449–453
ASGE/SAGES Working Group on Natural Orifice (2006) Translumenal Endoscopic Surgery. October 2005. Surg Endosc 20(2):329–333
Sclabas GM, Swain P, Swanstrom LL. (2006) Endoluminal methods for gastrotomy closure in natural orifice transenteric surgery (NOTES). Surg Innovation 13(1):23–30
J. Hazey, B. Needleman, D. Mikami, V. Narula, C. Paul, K. Hinshaw, S. Melvin transgastric instrumentation and bacterial contamination of the peritoneal cavity (accepted for oral presentation SAGES, 2007 Las Vegas)
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Hazey, J.W., Narula, V.K., Renton, D.B. et al. Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial. Surg Endosc 22, 16–20 (2008). https://doi.org/10.1007/s00464-007-9548-6
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DOI: https://doi.org/10.1007/s00464-007-9548-6