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.

ABSTRACT

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.