Abstract
Background
Most natural orifice transluminal endoscopic surgery (NOTES) procedures to date rely on the hybrid technique with simultaneous laparoscopic access to protect against access-related complications and to achieve adequate triangulation for dissection. This is done at the cost of the potential benefits of this new minimally invasive technique. This study aimed to evaluate the feasibility and safety of a transgastric (TG) pure-NOTES procedure in a diagnostic setting.
Methods
A TG pure-NOTES procedure with endoscopic ultrasonograpy (EUS)-guided access and over-the-scope-clip (OTSC) closure was performed for 10 pigs in a survival and feasibility study. A full macroscopic necropsy with subsequent histologic evaluation was performed on postoperative day (POD) 14. The outcome parameters were uncomplicated follow-up assessment, survival, intraoperative complications, intraabdominal pathology, macroscopic full-thickness closure, and histology-proven full-thickness healing of the gastrotomy.
Results
An uncomplicated postoperative course was reported for 9 of the 10 pigs, and survival was reported for all 10 pigs. For all the pigs, EUS-guided access was performed successfully with a median duration of 25 min (range, 12–62 min) and without intraoperative complications or access-related lesions at necropsy. An OTSC closure was achieved with a median duration of 11 min (range, 3–28 min). The OTSC provided immediate closure, but according to the authors’ definition of a full-thickness healing evaluated by histologic examination, this was not achieved in any of the cases. Although all the animals survived until POD 14, intraabdominal chronic abscesses were present in 3 of the 10 pigs at necropsy.
Conclusions
The EUS-guided TG access proved to be feasible without access-related complications. Although OTSC provided an immediate closure, the histopathology raised concerns regarding the risk of perforation. Together with the high risk of intraabdominal infection, TG pure-NOTES is not yet ready for routine clinical practice.
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Acknowledgments
The authors thank Olympus Corporation for supplying the endoscopic hardware necessary for this study. They also thank the EURO-NOTES Foundation, Toyota Foundation, Axel Muusfeldt Foundation, University of Copenhagen, the Research Council at Copenhagen University Hospital Herlev and the Capital Region of Denmark, and the Foundation for Health Research for financial support.
Disclosures
Barbara Juliane Holzknecht has received funds for travel from Pfizer and Merck Sharp & Dohme. Peter Vilmann has received a consultanship honorarium from MediGlobe GmbH, Grassau, Germany, and reimbursed travel from Olympus, Denmark. Søren Meisner is a consultant with Boston Scientific, Olympus Europa, and Coloplast Denmark. Lars Nannestad Jørgensen has received a travel grant from Olympus and lecture fees from Covidien. Jacob Rosenberg has received payment for expert testimony from Baxter Healthcare and research support from Covidien and Baxter Healthcare, and has had travel/accommodation expenses for international meetings covered by Johnson & Johnson. Anders Meller Donatsky, Luise Andersen, and Ole Lerberg Nielsen have no conflicts of interest or financial ties to disclose.
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Donatsky, A.M., Andersen, L., Nielsen, O.L. et al. Pure natural orifice transluminal endoscopic surgery (NOTES) with ultrasonography-guided transgastric access and over-the-scope-clip closure: a porcine feasibility and survival study. Surg Endosc 26, 1952–1962 (2012). https://doi.org/10.1007/s00464-011-2135-x
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DOI: https://doi.org/10.1007/s00464-011-2135-x