A prospective, randomized trial of esophageal submucosal tunnel closure with a stent versus no closure to secure a transesophageal natural orifice transluminal endoscopic surgery access site - 11/08/11
Reprint requests: William R. Brugge, MD, Gastroenterology Unit, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114.Résumé |
Background |
Secure esophagotomy closure methods are a critical element in the advancement of transesophageal natural orifice transluminal endoscopic surgery (NOTES) procedures.
Objective |
To compare the clinical outcomes in swine receiving an esophageal stent or no stent after a submucosal tunnel NOTES access procedure.
Design |
Prospective, randomized, controlled trial in 10 Yorkshire swine.
Setting |
Academic center.
Intervention |
An endoscopic mucosectomy device was used to create an esophageal mucosal defect. An endoscope was advanced through a submucosal tunnel into the mediastinum and thorax, and diagnostic mediastinoscopy and thoracoscopy were performed. Ten animals were randomized to no stenting (n = 5) or stenting (n = 5) with a prototype small-intestine submucosa–covered stent.
Main Outcome Measurements |
Gross and histologic appearance of the mucosectomy and esophagotomy sites as well as clinical outcomes.
Results |
There was a significant difference in the overall procedure time between the animals that received a stent (35.0 min, range 27-46.0 min) and those with no closure (19.0 min, range 17-32 min) (P value = .018). The unstented group achieved endoscopic and histologic evidence of complete re-epithelialization and healing (100%) at the mucosectomy site compared with the stented group (20%, P = .048). Stent migration into the stomach occurred in two swine. Both groups had complete closure of the submucosal tunnel and well-healed esophagotomy sites.
Limitations |
Animal study, small number of subjects.
Conclusion |
The placement of a covered esophageal stent significantly interferes with mucosectomy site healing.
Le texte complet de cet article est disponible en PDF.Abbreviations : NOTES
Plan
| DISCLOSURE: Funding for this project was provided by a grant from the Center for Integrative Medicine and Technology. D. Rattner disclosed a speaker relationship with Olympus and receipt of an honorarium. W. Brugge is a consultant for Boston Scientific. Cook Medical, Inc donated the prototype stent and additional endoscopic supplies essential for completing this trial. No other financial relationships relevant to this publication were disclosed. |
Vol 73 - N° 4
P. 785-790 - avril 2011 Retour au numéro
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