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.

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.